US 201603.13307A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2016/0313307 A1 Titmus et al. (43) Pub. Date: Oct. 27, 2016

(54) DIAGNOSTIC TEST STRIP FOR ORAL GOIN 33/543 (2006.01) SAMPLES AND METHOD OF USE GOIN 2L/78 (2006.01) THEREFORE (52) U.S. Cl. CPC ...... G0IN 33/521 (2013.01); G0IN 21/78 (71) Applicants: Ted Titmus, Mission Viejo, CA (US); (2013.01); G0IN 2 1/6428 (2013.01); G0IN William Pat Price, Henderson, NV 33/54366 (2013.01); G0IN 202 1/7759 (US) (2013.01) (72) Inventors: Ted Titmus, Mission Viejo, CA (US); William Pat Price, Henderson, NV (57) ABSTRACT (US) Some embodiments provide for a diagnostic test strip having a carrier strip, one or more test pads, and one or more (21) Appl. No.: 14/694,938 boundary projections which have an opening such that the (22) Filed: Apr. 23, 2015 boundary projections Substantially Surrounds three sides of each of the one or more test pads. Other embodiments Publication Classification provide for a method of detecting analytes in a patient sample, the method involving contacting an embodiment of (51) Int. Cl. a diagnostic test strip with a patients tongue Such that the GOIN 33/52 (2006.01) tongue contacts one or more test pads and reading the results GOIN 2L/64 (2006.01) of the analysis from the diagnostic test strip.

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DAGNOSTIC TEST STRIP FOR ORAL boundary projections which have an opening such that the SAMPLES AND METHOD OF USE boundary projections Substantially Surrounds three sides of THEREFORE each of the one or more test pads. From this description, in conjunction with other items, the advantages of the inven BACKGROUND OF THE INVENTION tion will become clear and apparent more so based upon the hereinafter descriptions and claims, which are Supported by 0001 1. Field of the Invention drawings with numbers relating to parts, wherein are 0002 The invention generally relates to diagnostic assay described in the following sections containing the relating materials. More specifically, the invention relates to diag numbers. nostic test strips for testing oral fluid and methods for the use 0008. In one aspect of the invention, a diagnostic test of said diagnostic test strips. strip is provided having a carrier strip, one or more test pads, 0003 2. Description of the Related Art and one or more boundary projections which have an 0004. Many types of assays have been used to detect the opening Such that the boundary projections Substantially presence of various Substances, generally referred to as Surrounds three sides of each of the one or more test pads. analytes, in physiological fluids such as urine and blood. Advantageously, the one or more test pads and the one or These assays often involve antigen-antibody reactions; syn more boundary projections are opposed on the opposite or thetic conjugates comprising radioactive, enzymatic, fluo same side of the carrier Strip. The one or more test pads and rescent, or visually observable metal Soltags; and specially the one or more boundary projections may be on the same designed reactor chambers. In all these assays, there is a side of the carrier strip and may be substantially at one end receptor; e.g., an antibody or chemical, which is specific for of the carrier strip. The opening in the one or more boundary the selected analyte; and a means for detecting the presence, projections may face toward the end of the carrier Strip and often the amount, of the analyte. While some tests are designed to make a quantitative determination, in many closest to the one or more test pads. Alternatively, the circumstances all that is required is a qualitative positive/ opening in the one or more boundary projections may face negative indication. However, in Some circumstances the away from the end of the carrier strip closest to the one or analyte of interest is present in the test sample in very Small more tests pads. concentrations. Such circumstances require an assay to be 0009. In some aspects of the invention, there are two or very sensitive in order to detect the presence, absence, more boundary projections on the same side of the carrier and/or concentration of the desired analyte. False positives strip. Optionally, at least one opening in a boundary projec and false negatives for qualitative assays can also be prob tion faces away from the closest end of the carrier strip lematic. closest to the one or more tests pads and the opening in 0005. Unlike other forms of fluid specimens, the collec another boundary region faces toward the closest end of the tion of oral fluid, such as Saliva, for diagnostic purposes is carrier strip. complicated by many factors. These factors include the low 0010. In another aspect, there are two or more boundary volumes of salivary fluid secreted into the oral cavity, the projections on the same side of the carrier strip and at least relatively high viscosity of salivary fluid, and the diverse one each of the two or more boundary projections are anatomic dispersion of the salivary glands. Because of these substantially at the opposite ends of the carrier strip and the factors, the testing of Salivary specimens has not been opening in each one faces toward the nearest end. Alterna extensively developed. However, it is known that human tively, the test strip may include two or more boundary saliva carries lymphocytes, plasma cells and immunoglobu projections on the same side of the carrier strip further lins that are directly related to the immunoglobulins found in wherein at least one each of the two or more boundary the blood. In addition, saliva carries immunoglobins that are projections are Substantially at the opposite ends of the believed to be peculiar to saliva, for example, the antibody carrier strip and the opening in each one faces away from the known as secretory IgA. Because of the association between nearest end. In still another embodiment, there are two or immunoglobulins of the blood and saliva, as well as the more boundary projections on the same side of the carrier occurrence of secretory IgA, antigen-antibody tests may strip and further wherein at least one each of the two or more prove useful for conducting diagnostic assays with Saliva. boundary projections are Substantially at the opposite ends 0006 Common techniques for collection of salivary fluid of the carrier strip and the opening in one faces away from involve the use of capillary tubes, micropipette Suctioning, the nearest end and the opening in the other faces toward the chewing on paraffin or foam, and/or aspiration from the nearest end. Optionally, there may be two or more boundary mouth into polypropylene Syringes. However, such tech projections on the same side of the carrier strip and further niques complicate the collection of salivary specimens and wherein at least two of the two or more boundary projections increase the likelihood of user error and/or false negatives. are placed substantially in the middle of the carrier strip and What is needed is a simple, accurate assay that provides the opening in each one faces away from each other and trustworthy Sample collection and detection of the presence, toward the nearest end. In another embodiment, there are absence, and/or concentration of one or more analytes two or more boundary projections on the same side of the present in oral fluid. These and other objects and features of carrier strip and further wherein at least two of the two or the invention will be apparent from the following descrip more boundary projections are placed Substantially in the middle of the carrier Strip and the opening in each one faces tion, drawings, and claims. toward each other. It will be appreciated that there may be SUMMARY OF THE INVENTION two or more boundary projections on the same side of the carrier strip and further wherein at least two of the two or 0007 Embodiments described herein are directed to more boundary projections are placed Substantially in the diagnostic test strips, and more specifically to test Strips middle of the carrier Strip and the opening in each one faces having a carrier strip, one or more test pads, and one or more the same end of the test strip. In some embodiments, there US 2016/03 13307 A1 Oct. 27, 2016 may be two or more boundary projections on the same side natively, there may be at least two boundary projections on of the carrier strip and further wherein at least one of the two the same side of the carrier strip each substantially in the or more boundary projections is placed Substantially in the center of the carrier strip and the openings in each one face middle of the carrier strip and the other is placed substan substantially away from each other. In still another aspect of tially at one end of the test strip and the opening in each one the invention, there may be three or more boundary projec faces away from each other and toward the nearest end. In tions on the same side of the carrier strip placed substantially other embodiments, there are two or more boundary pro at the edge of the carrier strip and substantially evenly jections on the same side of the carrier strip and further spaced from each other. The openings in the boundary wherein at least one of the two or more boundary projections projections may face Substantially toward the edge of the is placed substantially in the middle of the carrier strip and carrier strip or substantially away from the edge of the the other is placed substantially at one end of the test strip carrier strip. The openings in the boundary projections may and the opening in each one faces toward the same end of the alternate in facing Substantially to and away from the edge carrier strip. There may be two or more boundary projec of the carrier strip. In some aspects of the invention, the tions on the same side of the carrier strip and further wherein diagnostic test strip includes two or more concentric circles at least one of the two or more boundary projections is of multiple boundary projections on the same side of the placed substantially in the middle of the carrier strip and the carrier strip Substantially evenly spaced from each other. other is placed substantially at one end of the test strip and 0017. In some embodiments, the test strip includes two or the opening in each one faces toward the same side of the more boundary projections and at least one is on the opposite carrier strip. In some embodiments, there are two or more side of the others. boundary projections on the same side of the carrier strip and 0018. A method for detecting one or more analytes in a further wherein at least one of the two or more boundary patient sample is also disclosed. The method includes con projections is placed substantially in the middle of the tacting the test strip described above with a patients tongue carrier strip and the other is placed Substantially at one end so that the patients tongue contacts the one or more test of the test strip and the opening in each one faces Substan pads; and reading the results from the test strip. The method tially toward opposite sides of the carrier strip. may also include contacting the test strip with one or more 0011. In some embodiments, the sides of the one or more signaling reagents so that the one or more reagents contact boundary projections slope downward towards the opening the one or more test pads. The test strip may be contacted of the boundary projection. The sides of the one or more with the top and the sides of the patients tongue in a boundary projections may extend substantially for the entire substantially back and forth motion from substantially the length of the one or more test pads in other aspects of the tip to substantially the back of with the tongue. Optionally, invention. A diagnostic test strip is also contemplated, the test strip is contacted with the top and the sides of the wherein the sides of the one or more boundary projections patients tongue in a Substantially side-to-side motion along extend partially along the length of the one or more test pads the width of the tongue or the test strip may be contacted inside and closest to the end the boundary projection. with the top and the sides of the patients tongue in a 0012. In one aspect, the diagnostic test strip includes two Substantially circular motion. test pads. Optionally, the test strip comprises one test pad. 0019. The one or more test pads and one or more bound The one or more test pads may each contain a test reagent. ary projections may optionally be present on any side of the The one or more test pads may each contain the same or a carrier strip in any desired arrangement. Furthermore, the different test reagent. Advantageously, the diagnostic test openings in the boundary projections may be oriented in any strip includes one or more test pads that are on the same side arrangement relative to the carrier strip. Consequently, the of the carrier strip and contain two test reagents on different boundary projections direct the application of samples, such regions of the test pad. The test reagents may be arranged in as saliva, to the one or more test pads. Optionally, the one a pattern to give a signal to the user. or more test pads contain test reagents and/or signaling 0013 The carrier strip may be porous or non-porous. reagents that detect the presence, absence, and/or concen Similarly, the one or more test pads may be porous or tration of one or more analytes of interest. Other embodi non-porous. ments provide for a method of detecting analytes in a patient 0014. In certain embodiments, there are at least two or sample, the method involving contacting an embodiment of more test pads each with a different test reagent and each a diagnostic test strip with a patients tongue Such that the reagent tests for a different marker on the same analyte. tongue contacts one or more test pads and reading the results Optionally, at least one test pad further contains a signaling of the analysis from the diagnostic test strip. reagent. 0015 The diagnostic test strip may also include a sub BRIEF DESCRIPTION OF THE DRAWINGS stantially non-porous handle attached on one end or side of 0020 FIG. 1A is a side view of an embodiment of a the carrier strip. The carrier strip may be shaped in a number diagnostic test Strip having boundary projections Substan of configurations. It may be substantially square shaped, tially surrounding one test pad with an opening directed oval shaped, or Substantially circularly shaped. substantially toward one end of the test pad. 0016. In another embodiment, there are at least two 0021 FIG. 1B is a top view of an embodiment of a boundary projections on the same side of the carrier strip and diagnostic test Strip having boundary projections Substan the projections are placed Substantially opposite on Substan tially surrounding one test pad with an opening directed tially the edge of the circularly shaped carrier strip. The substantially toward one end of the test pad. openings in the boundary projections may face toward the 0022 FIG. 1C is a side view of an embodiment of a edge of the carrier strip or away from the edge of the carrier diagnostic test Strip having boundary projections Substan strip. Optionally, there may be at least one boundary pro tially surrounding one test pad with an opening directed jection in the substantially center of the carrier strip. Alter substantially toward one end of the test pad. US 2016/03 13307 A1 Oct. 27, 2016

0023 FIG. 1D is a top view of an embodiment of a 0038 FIG. 6A is a top view of an embodiment of a diagnostic test Strip having boundary projections Substan diagnostic test Strip having four test pads, each of which has tially surrounding one test pad with an opening directed multiple test pad layers. substantially toward one end of the test pad. 0039 FIG. 6B is an expanded view of an embodiment of 0024 FIG. 2A is a top view of an embodiment of a a test pad having two test pad layers. diagnostic test Strip having boundary projections Substan 0040 FIG. 6C is a perspective view of an embodiment of tially surrounding two test pads with openings directed a test pad having two test pad layers. Substantially towards each test pad. 0041 FIG. 6D is an expanded view of an embodiment of 0025 FIG. 2B is a top view of an embodiment of a a test pad having four test pad layers. diagnostic test Strip having boundary projections Substan 0042 FIG. 6E is a perspective view of an embodiment of tially surrounding two test pads with openings directed a test pad having four test pad layers. Substantially away from each test pad. 0043 FIG. 6F is an expanded view of an embodiment of 0026 FIG. 2C is a top view of an embodiment of a a test pad having three test pad layers. diagnostic test Strip having boundary projections Substan 0044 FIG. 6G is a perspective view of an embodiment of tially surrounding two test pads with openings directed a test pad having three test pad layers. 0045 FIG. 6H is an expanded view of an embodiment of Substantially away from each test pad. a test pad having six test pad layers. 0027 FIG. 2D is a top view of an embodiment of a diagnostic test Strip having boundary projections Substan 0046 FIG. 6I is a perspective view of an embodiment of tially surrounding two test pads with openings directed a test pad having six test pad layers. Substantially towards each test pad. DETAILED DESCRIPTION 0028 FIG. 2E is a top view of an embodiment of a diagnostic test Strip having boundary projections Substan 0047. The present application relates to U.S. patent appli tially surrounding two test pads with openings directed cation Ser. No. s filed entitled “DIAGNOS Substantially towards one side of the diagnostic test Strip. TICTEST STRIPS WITH MULTIPLE LAMINATED LAY 0029 FIG. 3A is a top view of an embodiment of a ERS CONTAINING ONE OR MORE REAGENT diagnostic test Strip having boundary projections Substan CARRYING PADS IN ONE OR MORE LAYERS, tially Surrounding three test pads with openings directed Attorney Docket Number TTUSA.005A2, U.S. patent appli Substantially towards one side of the diagnostic test strip and cation Ser. No. s filed entitled “MECHANI Substantially away from a handle. CAL ATTACHMENT OF TEST PADS TO A DIAGNOS TIC TEST STRIP, Attorney Docket Number TTUSA. 0030 FIG. 3B is a top view of an embodiment of a 006A2, U.S. patent application Ser. No. , filed diagnostic test Strip having boundary projections Substan entitled MECHANICAL ATTACHMENT OF tially Surrounding three test pads with openings directed TEST PADS TO A DIAGNOSTIC TEST DEVICE, Attor Substantially towards one side of the diagnostic test strip and ney Docket Number TTUSA.007A2, U.S. patent application Substantially towards a handle. Ser. No. , filed entitled “DIAGNOSTIC 0031 FIG. 3C is a top view of an embodiment of a TEST STRIP WITH SELF-ATTACHING TEST PADS diagnostic test Strip having boundary projections Substan AND METHODS OF USE THEREFORE, Attorney tially Surrounding three test pads with openings directed Docket Number TTUSA.008A2, U.S. patent application Ser. substantially away from the cluster of test pads. No. , filed entitled “DIAGNOSTIC TEST 0032 FIG. 3D is a top view of an embodiment of a STRIPS WITH FLASH MEMORY DEVICES AND diagnostic test Strip having boundary projections Substan METHODS OF USE THEREFORE, Attorney Docket tially Surrounding three test pads with openings directed Number TTUSA.009A2, U.S. patent application Ser. No. substantially away from the cluster of test pads. , filed entitled “DIAGNOSTIC TEST 0033 FIG. 3E is a top view of an embodiment of a STRIPS HAVING ONE OR MORE TEST PAD LAYERS diagnostic test Strip having boundary projections Substan AND METHOD OF USE THEREFORE, Attorney Docket tially Surrounding three test pads with two openings directed Number TTUSA.011A2, U.S. patent application Ser. No. substantially towards one side of the test strip and a third , filed entitled “SINGLE USE MEDICAL opening directed Substantially towards the opposite side of TEST PACKAGING”, Attorney Docket Number TTUSA. the test strip. 012A2, U.S. patent application Ser. No. , filed 0034 FIG. 4A is a top view of an embodiment of a entitled DIAGNOSTIC TEST STRIPS FOR diagnostic test Strip having boundary projections Substan DETECTION OF PAST OR PRESENT INFECTION OF VARIOUS STRAINS OF HEPATITIS Attorney Docket tially Surrounding nine test pads with openings directed Number TTUSA.013 A2, and U.S. patent application Ser. substantially away from the center of the cluster of test pads. No. , filed entitled “DIAGNOSTIC TEST 0035 FIG. 4B is a top view of an embodiment of a STRIPS FOR DETECTION OF PRE-SPECIFIED BLOOD diagnostic test Strip having boundary projections Substan ALCOHOL LEVEL' Attorney Docket Number TTUSA. tially Surrounding nine test pads with openings directed 014A2, all of whom have the inventors Ted Titmus and substantially towards the center of the cluster of test pads. William Pat Price, all of which are filed herewith this even 0036 FIG. 5A is a top view of an embodiment of a date, all of the disclosures of which are hereby expressly diagnostic test strip having boundary projections Surround incorporated by reference in their entirety and are hereby ing seven test pads. expressly made a portion of this application. 0037 FIG. 5B is a perspective view of an embodiment of 0048 Features of the present disclosure will become a diagnostic test strip having boundary projections Surround more fully apparent from the following description and ing seven test pads. appended claims, taken in conjunction with the accompa US 2016/03 13307 A1 Oct. 27, 2016 nying drawings. It will be understood these drawings depict 0.052 Any methods results may be read visually by an only certain embodiments in accordance with the disclosure embodiments user, if the application so desires, and/or any and, therefore, are not to be considered limiting of its scope; methods results may be stored in a memory device for the disclosure will be described with additional specificity recordation and later access. Alternatively, the results may and detail through use of the accompanying drawings. be read by someone other than the user or the supplier of the Descriptions of unnecessary parts or elements may be omit sample. In some circumstances, the results of the method ted for clarity and conciseness, and like reference numerals will be restricted from the user of the embodiment and/or the refer to like elements throughout. In the drawings, the size Supplier of the sample analyzed. and thickness of layers and regions may be exaggerated for 0053 Embodiments of the invention can be used to detect clarity and convenience. An apparatus, system or method any analyte which has heretofore been assayed using known according to some of the described embodiments can have immunoassay procedures, or known to be detectable by Such several aspects, no single one of which necessarily is solely procedures. Furthermore, it is envisioned that known meth responsible for the desirable attributes of the apparatus, ods can be modified as needed to afford suitable test reagents system or method. After considering this discussion, and and/or signaling reagents that will detect analytes that are particularly after reading the section entitled “Detailed similar to analytes that have been previously detected using Description one will understand how illustrated features known procedures. serve to explain certain principles of the present disclosure. 0054 Referring to the drawings, FIG. 1A illustrates sche 0049. Some embodiments of the invention provide for a matically a side view of an embodiment of a diagnostic test diagnostic test strip having a carrier Strip, one or more test strip, 100, having a carrier strip, 120, and one test pad, 130, pads, and one or more boundary projections. Moreover, the located on carrier strip 120. Optionally, test pad 130 may be boundary projections have an opening such that they Sub recessed into carrier strip 120. The embodiment in FIG. 1A stantially surround three sides of each of the one or more test also possesses boundary projections 140 and 150. Boundary pads. The one or more test pads and the one or more projection 140 serves as a backstop in this embodiment boundary projections are optionally opposed on any side of while boundary projections 150 serves as sides. Optionally, the carrier strip, and specifically on the opposite or same side diagnostic test strip 100 may have a handle. FIG. 1B of the carrier strip. In this regard, the one or more test pads illustrates schematically a top view of diagnostic strip 100. and the one or more boundary projections may be located on From FIG. 1B, one can see that test pad 130 is surrounded any side and/or any end of the carrier strip. by boundary projections 150 on two sides and boundary projection 140 on one side such that there is an opening in 0050. Other embodiments provide a method for detecting the boundary projections located substantially towards the one or more analytes in a sample, including but not limited end of diagnostic test strip 100. With such an arrangement to saliva, having contacting an embodiment of a diagnostic of boundary projections 140 and 150, this embodiment is test strip with a patients tongue so that the patients tongue Suited for Scraping a patients tongue Substantially towards contacts the one or more test pads; and results can be read the back of the patients throat. Such a scraping movement from the diagnostic test strip. These methods include con will afford collection of a sample of oral fluid within the tacting the test strip with one or more signaling reagents so boundary projections that Substantially Surround test pad that the one or more reagents contact the one or more test 130. pads. Furthermore, the embodiments may be contacted with 0055 FIGS. 1C and 1D illustrate schematically an alter the top and the sides of the patients tongue in a Substantially native embodiment which has openings in its boundary back and forth motion from substantially the tip to substan projections such that the embodiment is Suited for placement tially the back of with the tongue. Alternatively, embodi on a patients tongue towards the back of the patients throat ments may be contacted with the top and the sides of the and scraping the tongue by pulling the embodiment towards patients tongue in a Substantially side-to-side motion along the patient’s teeth. FIG. 1C illustrates schematically a side the width of the tongue. Likewise, embodiments may be view of an embodiment of a diagnostic test strip, 100, having contacted with the top and the sides of the patients tongue a carrier strip, 120, and one test pad, 130, located on carrier in a Substantially circular motion. strip 120. Optionally, test pad 130 may be recessed into 0051. As disclosed below, various features of the carrier strip 120. The embodiment in FIG. 1A also possesses embodiments and methods of using the embodiments enable boundary projections 140 and 150. Boundary projection 140 both trained and untrained personnel to reliably detect the serves as a backstop in this embodiment while boundary presence, absence, and/or concentration of one or more projections 150 serves as sides. Optionally, diagnostic test analytes in a sample. Indeed, features of the embodiments strip 100 may have a handle. FIG. 1D illustrates schemati and methods for their use allow for the detection of cally a top view of diagnostic strip 100. From FIG. 1D, one extremely small quantities of one or more particular analytes can see that test pad 130 is surrounded by boundary pro while avoiding false positives and false negatives. Further jections 150 on two sides and boundary projection 140 on more, features of the embodiments and methods for their use one side Such that there is an opening in the boundary allow for accurate and trustworthy attainment and/or storage projections located Substantially towards the middle of diag of information related to the tested sample. Optionally, nostic test strip 100 and away from its end. With such an embodiments may both produce a signal that communicates arrangement of boundary projections 140 and 150, a scrap information to the user and store information related to the ing movement will afford collection of a sample of oral fluid test sample in one or more memory devices. Consequently, within the boundary projections that substantially surround the invention is ideal for use in both prescription and test pad 130. over-the-counter assay test kits which will enable a con 0056 FIGS. 2A and 2B illustrate schematically an alter Sumer to self diagnose themselves and others, or test food native embodiment which has openings in its boundary and/or water prior to consumption. projections such that the embodiment is Suited for placement US 2016/03 13307 A1 Oct. 27, 2016 on a patients tongue and scraping with both backwards and substantially towards one side of the embodiment. Similarly, forwards motions to collect oral fluid. FIG. 2A illustrates there is an opening in the boundary projections Surrounding schematically a top view of an embodiment of a diagnostic test pad 235 directed substantially away from test pad 230 test strip, 200, having a carrier strip, 220, and two test pads, and substantially towards the other side of the embodiment. 230 and 235, located on carrier strip 220. Optionally, test With Such an arrangement of boundary projections, a side pads 230 and/or 235 may be recessed into carrier strip 220. to-side scraping movement will afford collection of a sample The embodiment in FIG. 2A also possesses boundary pro of oral fluid within the boundary projections that substan jections 240, 245, 250, and 255. Boundary projections 240 tially surround test pads 230 and 235. and 245 serve as backstops in this embodiment while 0059 FIG. 2D illustrates schematically a top view of an boundary projections 250 and 255 serve as sides. Optionally, alternative embodiment of a diagnostic test strip, 206, hav diagnostic test strip 200 may have a handle. From FIG. 2A, ing a carrier strip, 220, and two test pads, 230 and 235, one can see that test pads 230 and 235 are surrounded by located on carrier strip 220. Optionally, test pads 230 and/or boundary projections 250 and 255 on two sides, respec 235 may be recessed into carrier strip 220. The embodiment tively, and boundary projections 240 and 245 on one side, in FIG. 2D also possesses boundary projections 240, 245, respectively, such that there is an opening in the boundary 250, and 255. Boundary projections 240 and 245 serve as projections surrounding test pad 230 directed substantially backstops in this embodiment while boundary projections towards test pad 235. Similarly, there is an opening in the 250 and 255 serve as sides. Optionally, diagnostic test strip boundary projections surrounding test pad 235 directed 206 may have a handle. From FIG. 2D, one can see that test substantially towards test pad 230. With such an arrange pads 230 and 235 are surrounded by boundary projections ment of boundary projections, a back-and-forth scraping 250 and 255 on two sides, respectively, and boundary movement will afford collection of a sample of oral fluid projections 240 and 245 on one side, respectively, such that within the boundary projections that substantially surround there is an opening in the boundary projections Surrounding test pads 230 and 235. test pad 230 directed substantially towards test pad 235. 0057 FIG. 2B illustrates schematically a top view of an Similarly, there is an opening in the boundary projections alternative embodiment of a diagnostic test strip, 202, hav surrounding test pad 235 directed substantially towards test ing a carrier strip, 220, and two test pads, 230 and 235, pad 230. With such an arrangement of boundary projections, located on carrier strip 220. Optionally, test pads 230 and/or a side-to-side scraping movement will also afford collection 235 may be recessed into carrier strip 220. The embodiment of a sample of oral fluid within the boundary projections that in FIG. 2B also possesses boundary projections 240, 245, substantially surround test pads 230 and 235. 250, and 255. Boundary projections 240 and 245 serve as 0060 FIG. 2E illustrates schematically a top view of an backstops in this embodiment while boundary projections embodiment of a diagnostic test strip, 208, having a carrier 250 and 255 serve as sides. Optionally, diagnostic test strip strip, 220, and two test pads, 230 and 235, located on carrier 202 may have a handle. From FIG. 2B, one can see that test strip 220. Optionally, test pads 230 and/or 235 may be pads 230 and 235 are surrounded by boundary projections recessed into carrier strip 220. The embodiment in FIG. 2D 250 and 255 on two sides, respectively, and boundary also possesses boundary projections 240, 245, 250, and 255. projections 240 and 245 on one side, respectively, such that Boundary projections 240 and 245 serve as backstops in this there is an opening in the boundary projections Surrounding embodiment while boundary projections 250 and 255 serve test pad 230 directed substantially away from test pad 235. as sides. Optionally, diagnostic test strip 208 may have a Similarly, there is an opening in the boundary projections handle. From FIG.2E, one can see that test pads 230 and 235 surrounding test pad 235 directed substantially away from are surrounded by boundary projections 250 and 255 on two test pad 230. With such an arrangement of boundary pro sides, respectively, and boundary projections 240 and 245 on jections, a back-and-forth scraping movement will also one side, respectively, Such that there is an opening in the afford collection of a sample of oral fluid within the bound boundary projections surrounding test pads 230 and 235 ary projections that substantially surround test pads 230 and directed Substantially towards one end of diagnostic test 235. strip 208. With such an arrangement of boundary projec 0058 FIGS. 2C and 2D illustrate schematically an alter tions, a forward Scraping movement will afford collection of native embodiment which has openings in its boundary a sample of oral fluid within the boundary projections that projections such that the embodiment is Suited for placement substantially surround test pads 230 and 235. It is also on a patients tongue and scraping with side-to-side motions readily envisioned that the openings in the boundary pro to collect oral fluid. FIG. 2C illustrates schematically a top jections may both face any of the three remaining sides to view of an embodiment of a diagnostic test Strip, 204, having afford embodiments in which the pushing and/or pulling of a carrier strip, 220, and two test pads, 230 and 235, located test strip 208 towards the side with the open boundary on carrier strip 220. Optionally, test pads 230 and/or 235 projections will afford the collection of a sample of oral fluid may be recessed into carrier strip 220. The embodiment in within the boundary projections that substantially surround FIG. 2A also possesses boundary projections 240, 245, 250, test pads 230 and 235. and 255. Boundary projections 240 and 245 serve as back 0061 FIG. 3A illustrates schematically an embodiment stops in this embodiment while boundary projections 250 which has openings in its boundary projections such that the and 255 serve as sides. Optionally, diagnostic test strip 204 embodiment is Suited for placement on a patients tongue may have a handle. From FIG. 2C, one can see that test pads and Scraping Substantially towards the back of the patients 230 and 235 are surrounded by boundary projections 250 throat. FIG. 3A illustrates schematically a top view of an and 255 on two sides, respectively, and boundary projections embodiment of a diagnostic test strip, 300, having a carrier 240 and 245 on one side, respectively, such that there is an strip, 320, and three test pads, 330, 335, and 337, located on opening in the boundary projections Surrounding test pad carrier strip 320. Optionally, test pads 330,335, and 337 may 230 directed substantially away from test pad 235 and be recessed into carrier strip 320. The embodiment in FIG. US 2016/03 13307 A1 Oct. 27, 2016

3B also possesses boundary projections 340,345,347, 350, 355, and 357. Boundary projections 340,345, and 347 serve 355, and 357. Boundary projections 340,345, and 347 serve as backstops in this embodiment while boundary projections as backstops in this embodiment while boundary projections 350, 355, and 357 serve as sides. Optionally, diagnostic test 350, 355, and 357 serve as sides. Diagnostic test strip 303 strip 305 may have a handle. From FIG. 3C, one can see that also has an optional handle, 360, in contact with the carrier test pad 330 is surrounded by boundary projections 350 on strip. From FIG. 3A, one can see that test pad 330 is two sides and boundary projection 340 on one side such that surrounded by boundary projections 350 on two sides and there is an opening in the boundary projections directed boundary projection 340 on one side such that there is an substantially away from the cluster of test pads. Similarly, opening in the boundary projections directed Substantially test pad 335 is surrounded by boundary projections 355 on away from handle 360. Similarly, test pad 335 is surrounded two sides and boundary projection 345 on one side such that by boundary projections 355 on two sides and boundary there is an opening in the boundary projections directed projection 345 on one side such that there is an opening in Substantially away from the cluster of test pads. Likewise, the boundary projections directed Substantially away from test pad 337 is surrounded by boundary projections 357 on handle 360. Likewise, test pad 337 is surrounded by bound two sides and boundary projection 347 on one side such that ary projections 357 on two sides and boundary projection there is an opening in the boundary projections directed 347 on one side such that there is an opening in the boundary substantially away from the cluster of test pads. With such projections directed substantially away from handle 360. an arrangement of boundary projections a scraping move With Such an arrangement of boundary projections a scrap ment in a direction substantially away from backstops 340, ing movement in the direction Substantially away from 345, and 347 and in a substantially circular motion will handle 360 will afford collection of a sample of oral fluid afford collection of a sample of oral fluid within the bound within the boundary projections that substantially surround ary projections that substantially surround test pads 330, test pads 330, 335, and 337. 335, and 337. 0062 FIG. 3B illustrates schematically an alternative 0064 FIG. 3D illustrates schematically a top view of an embodiment which has openings in its boundary projections alternative embodiment of a diagnostic test strip, 307, hav Such that the embodiment is Suited for placement on a ing a carrier strip, 320, and three test pads, 330, 335, and patients tongue towards the back of the patients throat and 337, located on carrier strip 320. Optionally, test pads 330, scraping the tongue by pulling the embodiment towards the 335, and 337 may be recessed into carrier strip 320. The patient’s teeth. FIG. 3B illustrates schematically a top view embodiment in FIG. 3C also possesses boundary projections of an embodiment of a diagnostic test strip, 303, having a 340,345,347, 350,355, and 357. Boundary projections 340, carrier strip, 320, and three test pads, 330, 335, and 337, 345, and 347 serve as backstops in this embodiment while located on carrier strip 320. Optionally, test pads 330, 335, boundary projections 350, 355, and 357 serve as sides. and 337 may be recessed into carrier strip 320. The embodi Optionally, diagnostic test strip 307 may have a handle. ment in FIG. 3B also possesses boundary projections 340, From FIG. 3D, one can see that test pad 330 is surrounded 345,347, 350,355, and 357. Boundary projections 340,345, by boundary projections 350 on two sides and boundary and 347 serve as backstops in this embodiment while projection 340 on one side such that there is an opening in boundary projections 350, 355, and 357 serve as sides. the boundary projections directed Substantially away from Diagnostic test strip 303 also has an optional handle, 360, in the cluster of test pads. Similarly, test pad 335 is surrounded contact with the carrier strip. From FIG. 3B, one can see that by boundary projections 355 on two sides and boundary test pad 330 is surrounded by boundary projections 350 on projection 345 on one side such that there is an opening in two sides and boundary projection 340 on one side such that the boundary projections directed Substantially away from there is an opening in the boundary projections directed the cluster of test pads. Likewise, test pad 337 is surrounded substantially towards handle 360. Similarly, test pad 335 is by boundary projections 357 on two sides and boundary surrounded by boundary projections 355 on two sides and projection 347 on one side such that there is an opening in boundary projection 345 on one side such that there is an the boundary projections directed Substantially away from opening in the boundary projections directed Substantially the cluster of test pads. With such an arrangement of towards handle 360. Likewise, test pad 337 is surrounded by boundary projections a scraping movement in a direction boundary projections 357 on two sides and boundary pro substantially away from backstops 340,345, and 347 and in jection 347 on one side Such that there is an opening in the a substantially circular motion will afford collection of a boundary projections directed substantially towards handle sample of oral fluid within the boundary projections that 360. With such an arrangement of boundary projections a substantially surround test pads 330, 335, and 337. scraping movement in the direction of handle 360 will afford 0065 FIG. 3E illustrates schematically a top view of an collection of a sample of oral fluid within the boundary alternative embodiment of a diagnostic test strip, 309, hav projections that substantially surround test pads 330, 335, ing a carrier strip, 320, and three test pads, 330, 335, and and 337. 337, located on carrier strip 320. Optionally, test pads 330, 0063 FIGS. 3C and 3D illustrate schematically embodi 335, and 337 may be recessed into carrier strip 320. The ments which have openings in their boundary projections embodiment in FIG. 3E also possesses boundary projections Such that the embodiments are Suited for placement on a 340,345,347, 350,355, and 357. Boundary projections 340, patients tongue and Scraping in a substantially circular 345, and 347 serve as backstops in this embodiment while motion. FIG. 3C illustrates schematically a top view of an boundary projections 350, 355, and 357 serve as sides. embodiment of a diagnostic test strip, 305, having a carrier Optionally, diagnostic test strip 309 may have a handle. strip, 320, and three test pads, 330, 335, and 337, located on From FIG. 3E, one can see that test pads 330 and 337 are carrier strip 320. Optionally, test pads 330,335, and 337 may surrounded by boundary projections 350 and 357, respec be recessed into carrier strip 320. The embodiment in FIG. tively, on two sides and boundary projection 340 and 347, 3C also possesses boundary projections 340,345, 347, 350, respectively, on one side such that there is an opening in the US 2016/03 13307 A1 Oct. 27, 2016

boundary projections facing Substantially the same direction strip 520, and seven test pads, 531, 532,533,534, 535,536, and towards one side of diagnostic test strip 309. Similarly, and 537. In FIG.5A, test pads 531, 532,534, 535,536, and test pad 335 is surrounded by boundary projections 355 on 537 all display “minus’ signs indicating the absence of an two sides and boundary projection 345 on one side such that analyte and/or marker of an analyte, while test pad 533 there is an opening in the boundary projections facing indicates the presence of an analyte and/or marker of an Substantially the opposite direction of the openings in the analyte. Diagnostic test strip 500 also possesses boundary boundary projections surrounding test pads 330 and 337. projections, with a backstop, 540, and sides 550. FIG. 5B With Such an arrangement of boundary projections a scrap illustrates Schematically a perspective view of diagnostic ing movement in a direction Substantially side-to-side will test strip 500. afford collection of a sample of oral fluid within the bound 0069 FIG. 6A illustrates schematically a top view of an ary projections that substantially surround test pads 330, embodiment of a diagnostic test strip, 600, having a carrier 335, and 337. strip, 620, and four test pads, 630, 640, 650, and 660. In FIG. 0066 FIGS. 4A and 4B illustrate schematically embodi 6A, test pads 630, 640, 650, and 660 are optionally com ments which have openings in their boundary projections posed of optically transparent multiple layers as illustrated Such that the embodiments are Suited for placement on a in FIGS. 6B-6I. It is readily envisioned that one or more test patients tongue and Scraping in a substantially circular pads such as 630, 640, 650, and 660 may be present either forwards and backwards motion. FIG. 4A illustrates sche alone or in any manner of combination with other test pads, matically a top view of an embodiment of a diagnostic test including both single layer test pads and/or multiple layer strip, 400, having a carrier strip, 420, and nine test pads, 430, test pads having any number of test pad layers. 431, 432, 433, 434, 435, 436, 437, and 438, located on 0070 FIG. 6B schematically illustrates an embodiment carrier strip 420. Optionally, test pads 430, 431, 432, 433, of a test pad, 630, as comprising two test pad layers, 631 and 434, 435, 436, 437, and 438 may be recessed into carrier 632. Each of the test pad layers 631 and 632 are impregnated strip 420. The embodiment in FIG. 4A also possesses with test reagent and/or signaling reagent Such that the backstop boundary projections 440, 441, 442, 443, 444, 445, presence of a particular analyte, marker of an analyte, and/or 446, 447, and 448 and side boundary projections 450, 451, marker of different analytes will result in the generation of 452, 453, 454, 455, 456, 457, and 458. Optionally, diagnos a visual signal. In FIG. 6B the visual signal is denoted by a tic test strip 400 may have a handle. From FIG. 4A, one can shaded line. Upon detection of the presence of a particular see that test pad 430 is surrounded by boundary projections analyte, marker of an analyte, and/or marker of different 550 on two sides and boundary projection 540 on one side analytes in each of the test pad layers 631 and 632, a visual Such that there is an opening in the boundary projections signal is generated in each layer that appears to the observer directed substantially away from the cluster of test pads. Test as a “plus sign. This “plus' sign may confirm the presence pads 431, 432, 433, 434, 435, 436, 437, and 438 have a of a single analyte and/or multiple analytes, either of which similar arrangement. With Such an arrangement of boundary may confirm the diagnosis of one or more diseases, illnesses, projections Surrounding the test pads, a scraping movement or injuries. Thus, the use of test pads having layers com in a direction Substantially circular and away from backstops prising optically transparent material impregnated with test 440, 441, 442, 443, 444, 445, 446, 447, and 448 will afford reagent and/or signaling reagent provides a user with the collection of a sample of oral fluid within the boundary ability to perform a more complex analysis. FIG. 6C sche projections that substantially surround test pads 430, 431, matically illustrates the stacking of multiple test pad layers 432, 433, 434, 435, 436, 437, and 438. to afford an embodiment of a test pad such as 630. 0067 FIG. 4B illustrates schematically a top view of an 0071 FIG. 6D schematically illustrates an embodiment alternative embodiment of a diagnostic test strip, 405, hav of a test pad, 640, as comprising four test pad layers, 642, ing a carrier strip, 420, and nine test pads, 430, 431, 432, 644, 646, and 648. Each of the test pad layers 642, 644, 646, 433, 434, 435, 436, 437, and 438, located on carrier strip and 648 are impregnated with test reagent and/or signaling 420. Optionally, test pads 430, 431,432, 433,434, 435, 436, reagent such that the presence of a particular analyte, marker 437, and 438 may be recessed into carrier strip 420. The of an analyte, and/or marker of different analytes will result embodiment in FIG. 4B also possesses backstop boundary in the generation of a visual signal. In FIG. 6D the visual projections 440, 441, 442, 443, 444, 445, 446, 447, and 448 signal is denoted by a shaded line. Upon detection of the and side boundary projections 450, 451, 452, 453, 454, 455, presence of a particular analyte, marker of an analyte, and/or 456, 457, and 458. Optionally, diagnostic test strip 405 may marker of different analytes in each of the test pad layers have a handle. From FIG. 4B, one can see that test pad 430 642, 644, 646, and 648, a visual signal is generated in each is surrounded by boundary projections 550 on two sides and layer that appears to the observer as a “plus' sign. This boundary projection 540 on one side such that there is an “plus' sign may confirm the presence of a single analyte opening in the boundary projections directed Substantially and/or multiple analytes, either of which may confirm the away from the cluster of test pads. Test pads 431, 432, 433, diagnosis of one or more diseases, illnesses, or injuries. 434, 435, 436, 437, and 438 have a similar arrangement. Thus, the use of test pads having layers comprising optically With Such an arrangement of boundary projections Sur transparent material impregnated with test reagent and/or rounding the test pads, a scraping movement in a direction signaling reagent provides a user with the ability to perform substantially circular and away from backstops 440, 441, a more complex analysis. FIG. 6E schematically illustrates 442, 443, 444, 445, 446, 447, and 448 will afford collection the stacking of multiple test pad layers to afford an embodi of a sample of oral fluid within the boundary projections that ment of a test pad such as 640. substantially surround test pads 430, 431, 432, 433, 434, 0072 FIG. 6F schematically illustrates an embodiment of 435, 436, 437, and 438. a test pad, 650, as comprising three test pad layers, 652, 654, 0068 FIG. 5A illustrates schematically a top view of an and 656. Each of the test pad layers 652, 654, and 656 are embodiment of a diagnostic test strip, 500, having a carrier impregnated with test reagent and/or signaling reagent Such US 2016/03 13307 A1 Oct. 27, 2016 that the presence of a particular analyte, marker of an ing any number of test pad layers, including without limi analyte, and/or marker of different analytes will result in the tation test pads 630, 650, and/or 660. generation of a visual signal. In FIG. 6F the visual signal is 0075 One can readily appreciate the application of such denoted by a shaded line. Upon detection of the presence of embodiments of multiple layer test pads when knowledge of a particular analyte, marker of an analyte, and/or marker of a certain concentration is needed. As a non-limiting appli different analytes in each of the test pad layers 652, 654, and cation, the detection of a person’s blood level alcohol may 656, a visual signal is generated in each layer that appears be achieved using Such an embodiment. For a test pad to the observer as an “asterisk” sign. This “asterisk” sign comprising four test pad layers, such as 640, if test pad layer may confirm the presence of a single analyte and/or multiple 642 was sensitive to a blood alcohol level of at least 0.02%, analytes, either of which may confirm the diagnosis of one test pad layer 644 was sensitive to a blood alcohol level of or more diseases, illnesses, or injuries. Thus, the use of test at least 0.04%, test pad layer 646 was sensitive to a blood pads having layers comprising optically transparent material alcohol level of at least 0.06%, and test pad layer 648 was impregnated with test reagent and/or signaling reagent pro sensitive to a blood alcohol level of at least 0.08%, then the vides a user with the ability to perform a more complex application of a sample having a blood alcohol level at least analysis. FIG. 6G schematically illustrates the stacking of at the sensitive percentages would generate a signal. ASSum multiple test pad layers to afford an embodiment of a test pad ing that operating a motor vehicle with a blood alcohol level Such as 650. equal to or greater than 0.08% is illegal, then the application 0073 FIG. 6H schematically illustrates an embodiment of a sample that generates a “plus” sign as in FIGS. 6A, 6D, of a test pad, 660, as comprising six test pad layers, 661, 662, and 6E would indicate that the sample provider should not 663, 664, 665 and 666. Each of the test pad layers 661, 662, legally operate a motor vehicle. One will readily appreciate 663, 664, 665 and 666 are impregnated with test reagent that this described example is capable of extension to any and/or signaling reagent such that the presence of a particu multiple layer test pad comprising any number of test pad lar analyte, marker of an analyte, and/or marker of different layers, including without limitation test pads 630, 650, analytes will result in the generation of a visual signal. In and/or 660. FIG. 6H the visual signal is denoted by a shaded line. Upon 0076. As another non-limiting example, test reagents detection of the presence of a particular analyte, marker of and/or signaling reagents that are sensitive to markers spe an analyte, and/or marker of different analytes in each of the cific for hepatitis and/or liver damage may be applied to test test pad layers 661, 662, 663, 664, 665 and 666, a visual pads and/or layers within test pads. Consequently, the detec signal is generated in each layer that appears to the observer tion of markers specific for hepatitis and/or liver damage in as an “asterisk” sign. This “asterisk sign may confirm the each test pad and/or layers within test pads would generate presence of a single analyte and/or multiple analytes, either a signal. An individual test pad may optionally be sensitive of which may confirm the diagnosis of one or more diseases, to a single marker for hepatitis and/or liver damage. Alter illnesses, or injuries. Thus, the use of test pads having layers natively, a single test pad may be sensitive to multiple comprising optically transparent material impregnated with markers for hepatitis and/or liver damage. In Such an test reagent and/or signaling reagent provides a user with the embodiment, the detection of one or more markers for ability to perform a more complex analysis. FIG. 6I sche hepatitis and/or liver damage may produce a certain signal, matically illustrates the stacking of multiple test pad layers e.g. color, indicative of the number of markers detected to afford an embodiment of a test pad such as 650. and/or indicative of the exact marker detected. Alternatively, 0074 Alternatively, test pads having multiple layers, an embodiment may produce a signal in the form of a shape such as test pads 630, 640, 650, and 660, may indicate the that indicates the presence of one or more markers indicative concentration of one or more analytes present in a sample. of hepatitis and/or liver damage. For example, an embodi For example, test pad layers 631, 632, 642, 644, 646, 648, ment may have a test pad Such as 640, with test pad layers 652, 654, 656, 661, 662, 663, 664, 665, and/or 666 may have 642, 644, 646, and 648 each sensitive to one or more different sensitivities to a particular analyte that correlate to markers specific to an analyte Such as viral hepatitis. The a particular concentration of an analyte in a sample. As a respective detection of a marker in each of the test pad layers non-limiting example represented for test pad 640, at a 642, 644, 646, and 648 would generate a signal such that the certain concentration of analyte test pad layer 642 may detection of a marker in each of the test pad layers 642, 644, detect the analyte and generate a signal. Such as the shaded 646, and 648 would confirm the diagnosis of a viral hepa line indicated in FIGS. 6D and 6E. At a higher concentration titis. Although such an embodiment has been described with of analyte, both test pad layers 642 and 644 may detect the specific references to a viral hepatitis, it is envisioned that presence of the analyte and generate a signal. Such as the Such an embodiment may readily be tailored to detect any shaded lines indicated in FIGS. 6D and 6E. Still yet, at a number of analytes and/or markers that are specific to any higher concentration of analyte, test pad layers 642, 644, and analyte described below. 646 may detect the presence of the analyte and generate a signal, such as the shaded lines indicated in FIGS. 6D and Carrier Strip 6E. Finally, at an even higher concentration of analyte, all 0077. The carrier strip provides structural support for the four test pad layers 642, 644, 646, and 648 may detect the one or more test pads and the one or more boundary presence of the analyte and generate a signal. Such as the projections. As a structural Support, many materials Suitable shaded lines indicated in FIGS. 6A, 6D, and 6E. Conse for use in preparing the carrier strip are known in the art. quently, the different sensitivities of test pad layers 642, 644, Such materials include but are not limited to plastics includ 646, and 648 afford information to an observer about the ing polyethylene terephthalate, high-density polyethylene, presence and concentration of an analyte in a sample. One polypropylene, cellulose, Bakelite, polystyrene, high impact will readily appreciate that this illustrative example is polystyrene, acrylonitrile butadiene styrene, polyester, poly capable of extension to any multiple layer test pad compris urethanes, polycarbonates, polycarbonate/acrylonitrile buta US 2016/03 13307 A1 Oct. 27, 2016 diene styrene, polymethyl methacrylate, polytetrafluoroeth Surround a one or more test pads by extending as a first plane ylene, polyetherimide, phenol formaldehydes, urea that is substantially parallel to an axis of the embodiment, formaldehyde, melamine formaldehyde, polylactic acid, followed by a second plane extending Substantially perpen plastarch material, polyvinylchloride, nylon, and other poly dicular to the first plane, followed by a third plane extending amides, metals, alloys, ceramics, glass, wood, cardboard, Substantially perpendicular to the second plane and parallel paper, natural rubber, synthetic rubber, and other suitable to the first plane. Alternatively, each boundary projection polymers. Optionally, the carrier strip may be porous or may surround a one or more test pads in a substantially “V” non-porous. Optionally, the carrier Strip may facilitate the shaped manner wherein two planes Substantially surround at transmission of information from the one or more test pads least two sides, and preferably three sides, of the one or more to a memory device. Transmitted information may include, test pads. Furthermore, it is envisioned that substantially but is not limited to, the presence, absence, and/or concen arcuate, Substantially oval, and/or substantially circular tration of one or more analytes of interest. The carrier strip shaped boundary projections could be utilized or incorpo may facilitate the transmission of information from the one rated into the previously described boundary projections. or more test pads to the one or more memory devices by any 0080 When embodiments are placed in a patient’s mouth of several methods known in the art. Such methods include, and/or pressed against a patients tongue, the boundary but are not limited to, the transmission of electrical signals projections scrape and direct saliva onto the one or more which result from changes in the coulometry, amperometry, tests pads upon movement of the embodiment against the or potentiometry of the materials comprising the carrier tongue. Optionally, the Surface of the boundary projections strip. See U.S. Pat. No. 6,743,635 (Neel et al., issued on Jun. may contain dimples and/or grooves that impart a textured 1, 2001) and U.S. Pat. No. 6,946,299 (Neel at al., issued on feel to the tongue. Sep. 20, 2005), which are herein incorporated by reference. I0081. The opening in the one or more boundary projec Alternatively, the carrier Strip may facilitate the transmission tions may face any direction relative to the carrier strip and of optical signals which result from differences in the the one or more test pads. For example, the openings may reflection, transmission, Scattering, absorption, fluorescence, face toward the end of the carrier strip closest to the one or or electrochemiluminescense of the materials comprising more test pads, away from the end of the carrier strip closest the carrier strip and/or the test pads. See U.S. Pat. No. to the one or more tests pads, Substantially toward the edge 6,040,195 (Carroll et al., issued on Mar. 21, 2000) and U.S. of the carrier strip, substantially away from the edge of the Pat. No. 6,284.550 (Carroll et al., issued on Sep. 4, 2001) carrier strip, or alternate in facing Substantially to and away which are herein incorporated by reference. from the edge of the carrier strip. In one embodiment there 0078. The carrier strip's size and shape is only limited by are two or more boundary projections on the same side of the the desired application of the embodiment. For example, if carrier strip and further wherein at least one opening in a the desired application is testing a human patient, the boundary projection faces away from the closest end of the embodiment, and consequently the carrier strip, may be carrier strip closest to the one or more tests pads and the Smaller or larger depending upon the size of the human opening in another boundary region faces toward the closest patient. Likewise, if the desired application involves testing end of the carrier strip. Alternatively, at least one each of the an animal patient, the embodiment, and consequently the two or more boundary projections may be located at Sub carrier strip, may be smaller or larger depending upon the stantially the opposite ends of the carrier strip and the size of the animal patient. In some embodiments, the carrier opening in each one may optionally face toward the nearest strip is about 1, about 1.25, about 1.5, about 1.75, about 2, end, away from the nearest end, or the opening in one about 2.25, about 2.5, about 2.75, about 3, about 3.25, about boundary may face away from the nearest end and the 3.5, about 3.75, about 4, about 1-2, about 1-3, about 1-4, opening in the other boundary may face toward the nearest about 2-3, about 2-4, or about 3-4 inches in length. The end. It is readily envisioned that embodiments may have carrier Strip's shape may optionally be varied depending openings in their boundary projection in Such a fashion as to upon the desired application of the embodiment. Some make the embodiment particularly Suited for scraping a applications may require Substantially narrow, fat, rectan patients tongue substantially towards the back of the gular, circular, oval, square, triangular, or other shapes, patients throat. Alternatively, embodiments may have open including combinations of the indicated shapes. It is envi ings in their boundary projections in Such a fashion as to sioned that the shape of embodiments can be tailored to the make the embodiment particularly Suited for placement on a shape of the environment in which the embodiments will be patients tongue towards the back of the patients throat and applied. Moreover, the carrier strip may contain boundary scraping the tongue by pulling the embodiment towards the projections that Substantially surround one, two, three, and/ patient's teeth. Moreover, embodiments may have openings or four sides of one or more test pads to collect and/or direct in their boundary projections in Such a fashion as to make sample application to the one or more test pads. Further the embodiment particularly Suited for placement on a more, it is envisioned that a handle may be optionally patients tongue and scraping in a side-to-side and/or circu attached to a carrier Strip or in contact with a carrier strip, either directly or indirectly. lar motion. 0082 In additional embodiments, there are at least one Boundary Projections boundary projection in the substantially center of the carrier strip. In some embodiments, there are two or more boundary 007.9 The boundary projections facilitate the application projections on the same side of the carrier Strip with at least of oral liquids such as saliva to the one or more test pads. two of the two or more boundary projections placed sub Substantially Surrounding at least two sides, and preferably stantially in the middle of the carrier strip with their open three sides, of each of the one or more test pads, the ings optionally facing away from each other and toward the boundary projections channel saliva from the mouth to the nearest end, toward each other, or toward the same end of the one or more test pads. Each boundary projection may test strip. In another embodiment, there are two or more US 2016/03 13307 A1 Oct. 27, 2016 boundary projections on the same side of the carrier Strip diene styrene, polymethyl methacrylate, polytetrafluoroeth where at least one of the two or more boundary projections ylene, polyetherimide, phenol formaldehydes, urea is placed substantially in the middle of the carrier strip and formaldehyde, melamine formaldehyde, polylactic acid, the other is placed substantially at one end of the test strip plastarch material, polyvinylchloride, nylon, and other poly and the opening in each one optionally faces away from each amides, metals, alloys, ceramics, glass, natural rubber, Syn other and toward the nearest end, toward the same end, thetic rubber, and other suitable polymers. Optionally, the toward the same side, or toward opposite sides of the carrier boundary projections may comprise porous or non-porous strip. materials. 0083. In some embodiments, there are three or more boundary projections on the same side of the carrier Strip Test Reagents and Signaling Reagents placed substantially at the edge of the carrier strip and I0087 Test reagents and signaling reagents suitable for substantially evenly spaced from each other. In additional inclusion in embodiments are well known in the art. Such embodiments, there are two or more concentric circles of reagents include, but are not limited to, polyclonal antisera multiple boundary projections on the same side of the carrier and monoclonal antibodies that have specific binding prop strip Substantially evenly spaced from each other. In some erties and high affinity for virtually any antigenic Substance. embodiments, there are two or more boundary projections Literature affords many means of preparing Such reagents. and at least one is on the opposite side of the others. See, e.g., Laboratory Techniques in Biochemistry and 0084. In other embodiments, the sides of the one or more Molecular Biology, Tijssen, Vol. 15, Practice and Theory of boundary projections generally slope downward towards the Enzyme Immunoassays, chapter 13, The immobilization of opening of the boundary projection. The degree of slope Immunoreactants on Solid Phases, pp. 297-328, and the relative to the carrier strip may optionally be about 5, about references cited therein which are herein incorporated by 10, about 15, about 20, about 25, about 30, about 35, about reference. Additional assay protocols, reagents, and analytes 40, about 45, about 50, about 55, about 60, about 65, about useful in the practice of the invention are known per se. See, 70, about 75, about 80, about 85, about 5-15, about 10-20, e.g., U.S. Pat. No. 4.313,734 (Leuvering, issued on Feb. 2, about 15-25, about 20-30, about 25-35, about 30-40, about 1982), columns 4-18, and U.S. Pat. No. 4.366,241 (Tom et 35-45, about 40-50, about 45-55, about 50-60, about 55-65, al., issued on Dec. 28, 1982), columns 5-40 which are herein about 60-70, about 65-75, about 70-80, about 75-85, or incorporated by reference. about 80-90 degrees. Alternatively, the boundary projections I0088 Metal sols, including but not limited to gold sol, may generally slope downward towards the opening of the and other types of colored particles, including but not projection in a stepwise manner, such that there is an limited to, organic dye sols and colored latex particles, that extension of the boundary projection Substantially parallel to are useful as marker Substances in immunoassay procedures the carrier strip, followed by a lowering in height of the are also known per se and Suitable for use as test reagents boundary projection at an angle Substantially perpendicular and/or signaling reagents. See, for example, U.S. Pat. No. to the carrier strip. Such a stepwise sloping can be repeated 4.313,734 (Leuvering, issued on Feb. 2, 1982), the disclo as needed to afford a substantially downward slope. sure of which is incorporated herein by reference. For details 0085 Moreover, the boundary projections may extend and engineering principles involved in the synthesis of substantially perpendicular to the carrier strip for a desired colored particle conjugates see Horisberger, Evaluation of distance, and then the boundary projections may generally Colloidal Gold as a Cytochromic Marker for Transmission slope towards the opening in the boundary projections in any and Scanning Electron Microscopy, Biol. Cellulaire, 36, of the above described manners. Alternatively, the boundary 253–258 (1979); Leuvering et al. Sol Particle Immunoassay, projections may extend at Substantially non-perpendicular J. Immunoassay 1 (1), 77-91 (1980), and Frens, Controlled angles to the carrier Strip. Such angles include, but are not Nucleation for the Regulation of the Particle Size in limited to, about 5, about 10, about 15, about 20, about 25, Monodisperse Gold Suspensions, Nature, Physical Science, about 30, about 35, about 40, about 45, about 50, about 55, 241, pp. 20-22 (1973) which are herein incorporated by about 60, about 65, about 70, about 75, about 80, about 85, reference. about 5-15, about 10-20, about 15-25, about 20-30, about I0089 Test reagents for inclusion in the embodiments may 25-35, about 30-40, about 35-45, about 40-50, about 45-55, signal directly, Such as with an electrical or optical signal about 50-60, about 55-65, about 60-70, about 65-75, about (visible either to the naked eye, or with an optical filter or 70-80, about 75-85, or about 80-90 degrees. In another upon applied stimulation to promote fluorescence or phos embodiment, the sides of the one or more boundary projec phorescence). Test reagents may also signal indirectly Such tions may extend substantially for the entire length of the as with enzymes, e.g. alkaline phosphatase and/or horserad one or more test pads. Alternatively, the sides of the one or ish peroxidase, in combination with signaling reagents in the more boundary projections extend partially along the length form of enzymatic Substrates that will generate a signal upon of the one or more test pads inside and closest to the end the interaction with the enzyme. In some embodiments, the boundary projection. In one embodiment, there are at least signaling reagent and/or test reagent is incorporated into the two boundary projections on the same side of the carrier test pad. In other embodiments, the signaling reagent and/or strip and the projections are placed Substantially opposite on test reagent is added to the test sample before application to Substantially the edge of a circularly shaped carrier strip. the test pad. In additional embodiments, the signaling I0086. The boundary projections may be made of any reagent and/or test reagent is added to the test pad after suitable material known in the art, including but not limited introduction of the test sample. to polyethylene terephthalate, high-density polyethylene, 0090 Alcohol sensitive test reagents and methods are polypropylene, cellulose, Bakelite, polystyrene, high impact well known in the art. See, e.g. U.S. Pat. No. 5,563,073 polystyrene, acrylonitrile butadiene styrene, polyester, poly (Titmas, issued on Oct. 8, 1996) and Jai Moo Shin et al., urethanes, polycarbonates, polycarbonate/acrylonitrile buta Simple Diagnostic Tests to Detect Toxic Alcohol Intoxica US 2016/03 13307 A1 Oct. 27, 2016 tions, NIH (October 2008), which are hereby incorporated pad. Upon application of sample to such a test pad, no signal by reference in their entirety. In some embodiments, the test may result and a user could believe that an analyte is not reagent and/or signaling reagent from Alco ScreenTM pads, present—a false negative. Alternatively, test pads having a manufactured by Chematics, Inc. located in North Webster, pre-printed negative signal may suffer a similar occurrence Ind., is incorporated. Optionally, the test reagent and/or of a false negative if the test reagent is inactivated because signaling reagent from Alco ScreenTM pads is incorporated an analytes presence in a sample would not convert the in the one or more test pads, but it may also be applied to the pre-printed negative signal into a positive signal. Likewise, test pad after sample application or it may be applied to the an insufficient Volume of sample may generate no signal or sample before application to the test pad. In some embodi a negative signal and cause a user to believe that an analyte ments the test reagent and/or signaling reagent from the is not present. alcohol dehydrogenase method (ADH method) is incorpo 0.095 Any enzyme, antibody, dye buffer, chemical, sol, or rated in the one or more test pads, but it may also be applied combinations thereof may be incorporated so long as the to the test pad after sample application or it may be applied enzyme, antibody, dye buffer, chemical, metal Sol, or com to the sample before application to the test pad. In some binations thereof are capable of detecting the presence of embodiments the test reagent and/or signaling reagent from one or more analytes in a sample. See, e.g., U.S. Pat. No. the alcohol oxidase method method (ALOX method) is 6,383,736 (Titmas, issued on May 7, 2002), U.S. Pat. No. incorporated in the one or more test pads, but it may also be 7,858,756 (Owens et al., issued on Dec. 28, 2010), and U.S. applied to the test pad after sample application or it may be Pat. No. 7,790,400 (Jehanli et al., issued on Sep. 7, 2010) applied to the sample before application to the test pad. In which are hereby incorporated by reference in their entirety. Some embodiments the test reagent and/or signaling reagent from the sodium periodate method is incorporated in the one Test Pads or more test pads, but it may also be applied to the test pad after sample application or it may be applied to the sample 0096. The one or more test pads may be prepared from before application to the test pad. In some embodiments the any bibulous, porous, fibrous, or Sorbent material capable of test reagent and/or signaling reagent from the potassium rapidly absorbing a sample. Porous plastics material. Such as permanganate method (PA method) is incorporated in the polypropylene, polyethylene, polyvinylidene flouride, eth one or more test pads, but it may also be applied to the test ylene vinylacetate, acrylonitrile and polytetrafluoroethylene pad after sample application or it may be applied to the can be used. Optionally, the one or more test pads can be sample before application to the test pad. pre-treated with a surface-active agent to reduce any inher 0.091 Test reagents and/or signaling reagents may also ent hydrophobicity in the one or more test pads and enhance detect the storage and handling of embodiments. In some their ability to absorb a sample. The one or more test pads embodiments, test reagents and/or signaling reagents may be can also be made from paper or other cellulosic materials, sensitive to temperature and if the temperature of the including but not limited to nitrocellulose. Materials that are embodiment’s environment has exceeded or fallen below a now used in the nibs of fiber-tipped pens are also suitable for predetermined temperature, optionally for a predetermined incorporation in the one or more test pads. period of time, the test reagents and/or signaling reagents 0097. Optionally, the one or more test pads may be may be inactivated. Optionally, the inactivation of the test prepared from non-porous materials. In Such circumstances, reagents and/or signaling reagents may result in the trans the test reagents and/or signaling reagents may be coated on mission of a signal to the one or more memory devices the outer surface of the one or more test pads such that and/or to the user of the embodiment. contact with a sample containing an analyte will result in the 0092. In some embodiments, test reagents and/or signal generation of a signal. ing reagents may be sensitive to moisture, and if the humid 0098. Using known methods, test pads may be shaped or ity of the embodiment’s environment has exceeded or fallen extruded in a variety of lengths and cross-sections. Embodi below a predetermined level, optionally for a predetermined ments may possess one or more test pads of various sizes period of time, the test reagents and/or signaling reagents and shapes, and the size and shape of the one or more test may be inactivated. Optionally, the inactivation of the test pads are only limited by their number, size, and desired reagents and/or signaling reagents may result in the trans application of the embodiment in which they are incorpo mission of a signal to the one or more memory devices rated within. In some embodiments, the one or more test and/or to the user of the embodiment. pads are Substantially similar in size and/or shape. In other 0.093 Test reagents and/or signaling reagents may also embodiments, the one or more test pads may differ Substan detect whether a sufficient amount of sample has been tially in size and/or shape. It is readily envisioned that applied to an embodiment for analysis. For example, when embodiments may possess about one or more test pads, the sample is saliva, a test reagent and/or signaling reagent about two or more test pads, about three or more test pads, specific for a salivary enzyme, such as amylase, may detect about four or more test pads, about five or more test pads, the salivary enzyme’s presence if a sufficient volume of about six or more test pads, about seven or more test pads, sample has been applied. The detection of a sufficient about eight or more test pads, about nine or more test pads, sample may optionally be signaled to the user in the form of about ten or more test pads, about 1-4 test pads, about 1-10 a color or symbol. Using Such embodiments, the user would test pads about 1-100 test pads, about 2-100 test pads, about then know if a sufficient quantity of Sample was applied to 3-100 test pads, about 4-100 test pads, about 5-100 test pads, the one or more test pads to afford an accurate analysis. about 5-75 test pads, about 10-50 test pads, about 15-25 test 0094. Embodiments that detect storage and/or sufficient pads, and individual numbers of test pads therein. The one application of sample Volume are particularly capable of or more test pads may be made of the same material, or reducing the occurrence of false negatives. For example, optionally they may be made of different materials or even poor storage conditions may inactivate a test reagent in a test combinations of different materials. US 2016/03 13307 A1 Oct. 27, 2016

0099. In some embodiments, test pads may be prepared 0102 The test reagents applied to each layer of material from a single layer of material. In other embodiments, test may optionally be the same or different. When different test pads may be prepared from multiple layers of material. In reagents are applied to different layers of material compris both circumstances, test reagents and/or signaling reagents ing the one or more test pads, the test pad may be tailored may be impregnated in a single layer of material or in to generate a signal indicating the diagnosis of one or more multiple layers of material. The impregnation may take any illnesses, diseases, or injuries. One method for achieving Suitable form, including, but not limited to, a Substantially Such a diagnosis would be to have the individual layers uniform impregnation or impregnation with dots or stripes. comprising the test pad generate a signal in response to one Test reagents and/or signaling reagents can be impregnated or more symptoms of one or more illnesses, diseases, or injuries. For example, if the diagnosis of one or more in various concentrations in one or more of the multiple illnesses, diseases, or injuries required the determination of layers to tailor the sensitivity of the test pads to certain multiple analytes, then the detection of each analyte could analytes. Such sensitivity could afford information about the produce a portion of a symbol that is visible to the user. concentration of an analyte in the sample. Furthermore, the Upon formation of a complete symbol, the embodiment impregnation may optionally be conducted in a manner that would confirm the presence of a certain illness, disease, or will generate a signal observable by the user upon applica injury. Optionally, information relating to each specific tion of a sufficient quantity of sample, detection of an analyte could be transferred to the one or more memory analyte, or proper/improper storage of the embodiment. devices. 0100 When one or more test pads are comprised of 0103 Embodiments may optionally possess one or more multiple layers of material, one or more layers of material test pads and test reagents that detect analytes important to may be impregnated with an inert chemical Such that a line a certain age population (e.g. infants, children, young adults, or “minus sign' is displayed to the user. In some embodi adults, or elderly individuals). It is also envisioned that ments, the line or “minus sign could be in the form of a embodiments could possess one or more test pads and test material covering the one or more test pads to give a visual reagents that detect analytes important to certain categories impression of a line or “minus sign” on the one or more test of individuals (e.g., law enforcement agents, government pads. One or more additional layers of the material com employers, military members, chronic drug users, physi prising the one or more test pads could then be impregnated cians, veterinarians, dentists, parents, private sector employ with a test reagent and/or a signaling reagent that upon ers, aid workers, inmates, hospital patients, nursing home detecting a sufficient quantity of sample, appropriate storage patients, outdoorsmen, immuno-compromised individuals, temperature, and/or the presence of an analyte, the impreg or students). Embodiments may also be directed to analytes nated test reagent and/or signaling reagent will create a important to geographic regions (e.g. third-world countries, perpendicular line Such that a “plus sign” will be signaled to developed countries, or specific climate regions). Such the user. In other embodiments, the line or “minus sign embodiments of the invention simplify the number of dif displayed in the one or more test pads could be obscured by ferent embodiments that a user must purchase or travel with color or opaqueness when a test reagent and/or a signaling because users can select embodiments that will detect the reagent detects a sufficient quantity of sample, appropriate or analytes the users are most interested in, or are most inappropriate storage temperature, and/or the presence of an pertinent to a user's current or impending circumstances. analyte. Alternatively, the individual layers in a test pad may 0104. In one embodiment, a single test pad contains or be positioned such that the detection of an analyte in a lower has applied to it a single test reagent and/or signaling reagent layer of material is obscured by the detection of an analyte Suitable for detecting a single analyte. In another embodi in a layer of material positioned above the lower layer. It is ment, two or more test pads contain or have applied to one also envisioned that embodiments may have arrangements or more of them a single test reagent and/or signaling of test pads and/or arrangements of layers within multiple reagent Suitable for detecting a single analyte. Optionally, layered test pads Such that the detection of an analyte in the the single test reagent and/or signaling reagent on or applied test pads or the layers of a test pad generate a signal. Such to the two or more test pads may be the same or different. as a “plus sign” or “minus sign' to the user. Such embodi Furthermore, when different test reagents and/or signaling ments may comprise at least two layers of material, each reagents are used, the test reagents may be sensitive to the capable of generating a line upon detecting an analyte or a same marker on an analyte or the test reagents may be certain concentration of an analyte. Optionally, the lines may sensitive to different markers on an analyte. The analyte may intersect to generate a "plus' sign or other signal upon the optionally be the same or different. When different analytes detection of an analyte in the at least two layers of material. and different test reagents and/or signaling reagents are used, Alternatively, embodiments may comprise at least four the analytes and test reagent and/or signaling reagents may layers of material, each capable of generating a line upon be tailored to detect different symptoms of the same illness, detecting an analyte or a certain concentration of an analyte disease, or injury. In some embodiments, a diagnosis can be in the at least four layers of material. Optionally, the lines made based upon the detection of all the symptoms specific may intersect at one or more points such that a “plus' sign to an illness, disease, or injury. In other embodiments, a or other symbol is formed. diagnosis can be made based upon the absence of one or 0101 While the aforementioned embodiments have been more analytes specific to an illness, disease, or injury. Using discussed with reference to “minus’ and “plus signs, it is these described test pads, it is readily apparent that the envisioned that any symbol, including color changes, could reduction of false negatives and false positives can be be used to convey similar information to a user. The meaning achieved by including redundancy in the embodiments. of any desired symbol or color change could be included in 0105. In one embodiment, a single test pad may contain the packaging of an embodiment or imprinted on an embodi or have applied to it two or more reagents suitable for ment. detecting and/or signaling a single analyte. These two or US 2016/03 13307 A1 Oct. 27, 2016 more test reagents and/or signaling reagents may be sensi cinolazepam, clonazepam, cloxazolam, clorazepate, diaz tive to the same marker of an analyte. Optionally, these two epam, estazolam, fludiazepam, flunirazepam, flurazepam, or more reagents may be sensitive to different markers on the flutoprazepam, halazepam, ketazolam, loprazolam, loraZe same analyte. In some embodiments, the two or more test pam, lormetazepam, medazepam, midazolam, nimetazepam, reagents and/or signaling reagents may be applied to the nitrazepam, nordazepam, oxazepam, phenazepam, pinaZe same region of the test pad. In other embodiments, the two pam, praZepam, premazepam, quaZepam, temazepam, tet or more test reagents and/or signaling reagents may be razepam, triazolam, and other benzodiazepine receptor applied to different regions of the same test pad. The number ligands such as clobazam, DMCM, flumazenil, esZopiclone, of test reagents and/or signaling reagents Suitable for incor Zaleplon, Zolpidem, and Zopiclone. Examples of phenothi poration or application to a single test pad is limited only by azines include chlorpromazine, promethazine, triflupromaz the application of the diagnostic test strip. It is readily ine, methotrimeprazine, mesoridazine, thioridazine, flu envisioned that embodiments may possess about one or phenazine, perphenazine, prochlorperazine, and more, about two or more, about three or more, about four or trifluoperazine. Examples of other benzheterocyclics more, about five or more, about six or more, about seven or include, but are not limited to, carbamazepine and imip more, about eight or more, about nine or more, about ten or ramine. more, about 1-4, about 1-10, about 1-100, about 2-100, 0110. Additional drug analytes include alkaloids, such as about 3-100, about 4-100, about 5-100, about 5-75, about agents that interact with opioid receptors including mor 10-50, about 15-25, and individual numbers therein, of test phine, dihydromorphine, desomorphine, hydromorphone, reagents and/or signaling reagents incorporated or applied to nicomorphine, oxymorphone, hydromorphinol, nalbuphine, one or more test pads. Using these described test pads, it is naloxone, naltrexone, buprenorphine, etorphine, metopon, readily apparent that the reduction of false negatives and diacetyldihydromorphine, thebacon, methodone, codeine, false positives can be achieved by including redundancy in hydrocodone, dihydrocodeine, oxycodone, papaveretum, the embodiments. oripavine, thebaine, tapentadol, and heroin, agents that exert 0106 The one or more test pads suitable for use in an effects on serotonin receptors, such as cocaine (and other embodiment will readily detect analytes present in liquid reuptake inhibitors, including norepinephrine, dopamine, samples, such as saliva. It is also envisioned that a test pad and serotonin reuptake inhibitors); cocaine metabolites Such may be capable of detecting an analyte present in Solid as benzoylecgonine; ergot alkaloids; steroid alkaloids; imi and/or semi-solid samples. When solid and/or semi-solid naZoyl alkaloids; quinazoline alkaloids; isoquinoline alka samples are analyzed, it is understood that a liquid may loids; quinoline alkaloids; and diterpene alkaloids. optionally be applied to the test pad to facilitate analysis. 0111. The next group of drug analyte includes steroids, 0107. When liquids and/or liquid samples are applied to including the estrogens, gestogens, androgens, andrenocor test pads, lateral flow through material may result from tical steroids, bile acids, cardiotonic glycosides and agly Surface tension, cohesion, adhesion, wicking, and/or capil cones, which includes digoxin and digoxigenin, Saponins lary action. In some embodiments, lateral flow is confined to and Sapogenins, their derivatives and metabolites. the test pad region. In other embodiments, lateral flow is 0112 The next group of drug analytes is the barbiturates, confined to individual test pads. In further embodiments, such as barbital, allobarbital, amobarbital, aprobarbital, lateral flow is confined to individual layers of a multi-layer alphenal, brallobarbital, Phenobarbital, pentobarbital, Nem test pad. The phrase “lateral flow is confined' means that an butal, secobarbital, diphenylhydantonin, primidone, and embodiment does not utilize fluid communication outside of ethosuximide. Additionally, drugs similar in effect to barbi the indicated portion of the embodiment. turates are potential analytes, such as methaqualone, cloro qualone, diprocqualone, etaqualone, mebroqualone, meclo Analytes qualone, methylmethaqualone, and nitromethaqualone. 0108. An assay based on the principles described herein 0113. The next group of drug analytes is aminoalkylben can be used to determine a wide variety of analytes by Zenes, including the phenethylamines such as amphetamine, choice of appropriate test reagents and/or signaling reagents. methamphetamine, lisdexamfetamine, mescaline, and cat The embodiments described herein can be used to test for the echolamines, which includes ephedrine, L-dopa, epineph existence of analytes including, but not limited to, drugs, rine, narceline, and papaverine. especially drugs of abuse, heavy metals, pesticides, pollut 0114. The next group of drug analytes includes those ants, proteins, polynucleotides such as DNA, RNA, rRNA, derived from marijuana, which includes cannabinol, tetra tRNA, mRNA, and siRNA, hormones, vitamins, microor hydrocannabinol, 11-nor-9-carboxy-delta-9-tetrahydrocan ganisms such as bacteria, fungi, algae, protozoa, multi nabinol, nabilone, dronabinol, marinol, and cannabinoids cellular parasites, and viruses, tumor markers, liver function Such as cannabidiol, cannabinol, and tetrahydrocannabi markers, kidney function markers, blood coagulation fac Varin. tors, and toxins. The embodiments may also optionally 0115 The next group of drug analytes are those that detect metabolites of each of the aforementioned examples interact with the N-methyl d-aspartate (“NMDA) receptor, of analytes. Furthermore, some embodiments may also including agonists, modulators, and antagonists such as detect their storage conditions, specifically the temperature 1-(1-phylcyclohexyl)piperidine (phencyclidine or “PCP), and humidity of their environment, and/or the application of R-2-amino-5-phosphonopentanoate, 2-amino-7-phosphono an appropriate quantity of sample for analysis. heptanoic acid, (3-(R)-2-carboxypiperazin-4-yl)-prop-2- 0109 More specific examples of drug analytes include enyl-1-phosphonic acid), PEAQX, selfotel, amantadine, benzheterocyclics, the heterocyclic rings being azepines, dextrallorphan, dextromethorphan, dextrorphan, dizocil diazepines and phenothiazines. Examples of azepines pine, ethanol, eticyclidine, gacyclidine, ibogaine, ketamine, include fenoldopam. Examples of benzodiazepines include memantine, methoxetamine, rolicyclidine, tenocyclidine, alprazolam, bretaZenil, bromazepam, chlorodiazepoxide, tiletamine, neramexane, eliprodil, etoxadrol, deXOXadrol, US 2016/03 13307 A1 Oct. 27, 2016 14

NEFA, remacemide, delucemine, 8A-PDHQ, aptiganel, B-glycoprotein I, B-glycoprotein II, immunoglobulins A, HU-211, remacemide, atomoxetine, rhynchophylline, D, E, G, M, prothrombin, thrombin, and protein markers in 1-aminocyclopropanecarboxylic acid, 7-chlorokynurenate, cancers including, but not limited to, breast cancer, prostate 5,7-dichlorokynurenic acid, kynurenic acid, and lacosamide. cancer, melanoma, carcinoma, pancreatic cancer, liver can 0116. The next group of drugs is antibiotics, which cer, and brain cancer. include, for example, beta-lactam antiobiotics such as peni I0121 Additional protein analytes of interest include ala cillins and cephalosporins, penems and carbapenems, anti nine aminotransferase and aspartate aminotransferase. Ala microbials such as aminoglycosides, ansamycins, carba nine aminotransferase is markedly elevated when hepatitis is cephems, glycopeptides, lincosamides, lipopetides, present in the liver. Such elevation for alanine aminotrans macrollides, monobactams, nitrofurans, quionolones, poly ferase may include at least about 1.25, 1.5, 1.75, 2, 2.25, 2.5, peptide-based antibiotics, chloromycetin, actinomycetin, 2.75, and 3.0 times the normal levels associated with a spectinomycin, Sulphonamides, trimethoprim, tetracyclines, person lacking liver damage. Aspartate aminotransferase is and beta-lactamase inhibitors such as calvulanic acid, taZo elevated when cellular damage occurs, such as liver damage, bactam, and Sulbactam. skeletal muscle damage, and acute myocardial infarction. 0117. Other individual miscellaneous drug analytes Additionally, levels are elevated because of congestive heart include nicotine, caffeine, gamma-hydroxybutyric acid, dex failure, pericarditis, cirrhosis, metastatic liver disease, skel tromoramide, ketobemidone, piritramide, dipipanone, phen etal muscle diseases, and generalized infections such as adoxone, benzylmorphine, nicocodeine, dihydrocodeinone mononucleosis. Such elevation for aspartate aminotrans enol acetate, tilidine, meptazinol, propiram, acetyldihydro ferase may include at least about 1.25, 1.5, 1.75, 2, 2.25, 2.5, codeine, pholcodine, 3.4-methylenedioxymethamphet 2.75, and 3.0 times the normal levels associated with a amine, psilocybin, 5-methoxy-N,N-diisopropyltryptamine, person lacking liver damage. Consequently, the detection of peyote, 2,5-dimethoxy-4-methylamphetamine, 2C-T-7 (a alanine aminotransferase and/or aspartate aminotransferase psychotropic entheogen), 2C-B, cathinone, alpha-methyl is of therapeutic importance. tryptamine, bufotenin, benzylpiperazine, methylphenidate, 0.122 Specific examples of peptide and protein hormone dexmethylphenidate, laudanum, fentanyl, mixed amphet analytes include parathyroid hormone (parathromone), thy amine salts (i.e. Adderall), lisdexamfetamine, dextroamphet rocalcitonin, insulin, glucagon, relaxin, erythropoietin, mel amine, dextromethamphetamine, pethidine, anabolic Ste anotropin (melanocyte-stimulating hormone and interme roids, talbutal, butalbital, buprenorphine, Xyrem, paregoric, din), Somatotropin (growth hormone), corticotropin modafinil, difenoxin, diphenoxylate, promethazine, pre (adrenocorticotropic hormone), thyrotropin, prolactin, fol gabaline, pyrovalerone, atropine, and other Schedule I-V licle-stimulating hormone, luteinizing hormone), chorionic classified drugs, glucose, cholesterol, bile acids, fruc gonadotropin (hCG), oxytocin, and vasopressin. tosamine, carbohydrates, metals which includes, but is not I0123 Specific examples of polynucleotide analytes limited to lead and arsenic, alcohols (i.e. methanol, ethanol, include DNA and RNA as well as their nucleoside and propanol, butanol, and Cso containing alcohols), mepro nucleotide precursors, which include ATP NAD, FMN, bamate, serotonin, meperidine, amitriptyline, nortriptyline, adenosine, guanosine, thymidine, cytidine, and uracil with lidocaine, procaineamide, acetylprocainearnide, propra their appropriate Sugar and phosphate Substituents. nolol, griseofulvin, valproic acid, butyrophenones, antihis 0.124 Specific examples of vitamin analytes include Vita tamines, and anticholinergic drugs, such as atropine. min A (i.e. retinol), B (e.g. B or thiamine, B or riboflavin, 0118 Pesticide analytes of interest include categories B or niacin, Bs or pantothenate, B or pyridoxine, B, or Such as algicides, avicides, bactericides, fungicides, herbi biotin, Bo or folic acid, and B2), C (i.e. ascorbic acid), D cides, insecticides, miticides, molluscicides, nematicides, (e.g. calciferol, D, and D), E (i.e. tocopherol), K, and rodenticides, Virucides, and specifically polyhalogenated Vitamin derivatives or metabolites such as nicotinamide. biphenyls, phosphate esters, thiophosphates, carbamates, 0.125 Specific examples of microorganism analytes, and polyhalogenated Sulfenamides. including infectious disease agents, include corynebacteria, 0119) Additional chemical analytes of interest include pneumococci, streptococci, staphylococci, neisseriae, hemo fertilizers such as ammonium derivatives, nitrates, and phos philus influenzae, pasteurellae, brucellae, aerobic spore phates; heavy metals such as lead, mercury, uranium, plu forming bacilli, anaerobic spore-forming bacilli, mycobac tonium, arsenic, cadmium, chromium, and nickel teria, actinomycetes (fungus-like bacteria), the spirochetes, 0120 More specific examples of protein analytes include mycoplasmas, and other pathogens, such as listeria mono antibodies, protamines, histones, albumins, globulins, scle cytogenes, erysipelothrix rhusiopathiae, streptobacillus roproteins, phosphoproteins, mucoproteins, chromoproteins, moniliformis, donvania granulomatis, bartonella bacillifor lipoproteins, nucleoproteins, glycoproteins, proteoglycans, mis, rickettsiae (bacteria-like parasites), fungi, agents caus and unclassified proteins, such as Somatotropin, prolactin, ing venereal diseases such as chlamydia, chancroid, granu insulin, and pepsin. A number of proteins found in the loma inguinale, gonorrhea, syphilis, jock itch, yeast human plasma are important clinically and include prealbu infection, herpes simplex, HPV. crab louse, scabies, tricho min, albumin, C.-lipoprotein, C-acid glycoprotein, C.-an moniasis, and infectious diarrheal microorganisms such as titrypsin, C.-glycoprotein, transcortin, 4.6S-postalbumin, camplylobacter, Salmonellae, Shigellae, Escherichia coli, tryptophan-poor, C.-glycoprotein, C.X-glycoprotein, thy Clostridium difficile, Giardia lamblia, Entamoeba his roXin-binding globulin, inter-O-trypsin-inhibitor, Gc-globu tolytica, and organisms causing leptospirosis, nosocomial lin (Gc I-I, Gc 2-1, Gc 2-2), haptoglobin, ceruloplasmin, infections, staphylococcal enterotoxicosis, typhoid fever, cholinesterase, C-lipoprotein(s), myoglobin, C-reactive cholera, Vibrio gastroenteritis, yersinia gastroenteritis, Protein, C-macroglobulin, C-HS-glycoprotein, Zn-O-gly clostridium perfingens gastroenteritis, bacillus cereus gas coprotein, C-neuramino-glycoprotein, erythropoietin, B-li troenteritis, aflatoxin poisoning, amoebic dysentery, cryp poprotein, transferrin, hemopexin, fibrinogen, plasminogen, tosporidiosis, cyclospora diarrheal infection. Other micro US 2016/03 13307 A1 Oct. 27, 2016

organism analytes include viruses, such as herpes viruses, tongue such that the tongue contacts the one or more test pox viruses, picornaviruses, myxoviruses (influenza A, B, pads. Alternatively, salivary samples may be obtained by and C, and mumps, measles, rubella, etc.), arboviruses, contacting an embodiment with the top and/or sides of a reoviruses, rotoviruses, noroviruses, adenoviruses, astrovi patients tongue using a substantially back and forth motion ruses, hepatitis, human immunodeficiency virus, and tumor from substantially the tip of the tongue to substantially the viruses. back of the tongue. Furthermore, salivary samples may be 0126 The categories of protein analytes and microorgan obtained by contacting an embodiment with the top and/or ism analytes may optionally overlap. For example, a micro sides of a patients tongue using a substantially side-to-side organism analyte may be detected via the analysis of a motion along the width of the tongue. Similarly, salivary protein analyte specific for the microorganism analyte. A samples may also be obtained by contacting an embodiment protein analyte specific for a microorganism analyte may with the top and/or sides of a patients tongue using a include an antibody specific for a microorganism analyte, or substantially circular motion. For each of the above marker thereof. As a non-limiting example, for a microor described sample collection methods, the results of the ganism analyte such as viral hepatitis, antibodies specific to analysis could then be read directly from the diagnostic test any of viral hepatitis A, B, C, D, E, F and/or G may comprise strip. Optionally, test results could be stored to a suitable the protein analyte. Such antibodies include, but are not memory device for recordation and later access. limited to, immunoglobins such as IgA, Ig|D, IgE, and specifically IgM and/or IgG, and antibodies to Surface CONCLUSION antigens, envelope antigens, core antigens, and/or delta antigens (e.g. Small and/or large). Specific examples of 0131 While the invention has been described with ref antigens for viral hepatitis B include hepatitis B surface erence to the specific embodiments thereof, it should be antigen (HBSAg), hepatitis B envelope antigen (HBeAg), understood by those skilled in the art that various changes hepatitis B core antigen (HBcAg). Alternatively, a protein may be made and equivalents may be substituted without analyte specific for a microorganism analyte may include a departing from the true spirit and scope of the invention. protein analyte characteristically produced by the microor This includes embodiments which do not provide all of the ganism analyte. As a non-limiting example, for a microor benefits and features set forth herein. In addition, many ganism analyte Such as viral hepatitis, proteins specific to modifications may be made to adapt a particular situation, any of viral hepatitis A, B, C, D, E, and/or F may comprise material, composition of matter, process, process step or the protein analyte. Such protein analytes include, but are steps, to the objective, spirit and scope of the present not limited to, structural and/or nonstructural proteins. Spe invention. All such modifications are intended to be within cific examples of protein analytes for viral hepatitis C the scope of the claims appended hereto. Accordingly, the include, but are not limited to structural proteins such as E1 scope of the invention is defined only by reference to the and/or E2, and/or nonstructural proteins such as NS2, NS3, appended claims. NS4, NS4A, NS4B, NS5, NS5A, NS5B, and peptide por What is claimed is: tions thereof. 1. A diagnostic test strip comprising a carrier strip, one or 0127. The above described analytes possess at least one more test pads, and one or more boundary projections, marker recognized by at least one test reagent and/or sig wherein the one or more test pads and the one or more naling reagent. Optionally, the above described analytes may boundary projections are opposed on the opposite or same possess multiple markers recognized by the same and/or side of the carrier strip, and further wherein the boundary different test reagents and/or signaling reagents. It is readily projections have an opening Such that the boundary projec envisioned that a marker may be the entire analyte and/or a tions substantially surrounds three sides of each of the one portion thereof. or more test pads. 2. The diagnostic test strip of claim 1, wherein the one or Samples more test pads and the one or more boundary projections are 0128. An analyte of interest may be present in a wide on the same side of the carrier strip and are substantially at variety of environments, and it is envisioned that a person one end of the carrier strip. having ordinary skill in the art will readily understand that 3. The diagnostic test strip of claim 2, wherein the the components and embodiments discussed above can be opening in the one or more boundary projections faces modified as needed to accommodate different environments toward the end of the carrier strip closest to the one or more of samples. test pads. 0129. Analytes of interest may be found in a patients 4. The diagnostic test strip of claim 2, wherein the physiological fluids, Such as mucus, blood, serum, blood opening in the one or more boundary projections faces away plasma, lymph, puss, urine, feces, cerebral spinal fluid, from the end of the carrier strip closest to the one or more ocular lens liquid, ascites, semen, sputum, Sweat, secreted tests pads. oils, and preferably saliva. Samples for testing analytes may 5. The diagnostic test strip of claim 1, wherein there are be obtained using techniques known or envisioned to pro two or more boundary projections on the same side of the vide samples of Such physiological fluids. Optionally, ana carrier strip and further wherein at least one opening in a lytes may be detected by directly contacting embodiments of boundary projection faces away from the closest end of the the diagnostic test strips with the patient’s body, Such as carrier strip closest to the one or more tests pads and the their skin, eyes, mouth cavity regions including the tongue, opening in another boundary region faces toward the closest tonsils, and inner lining of the mouth and throat, and the end of the carrier strip. nasal cavity. 6. The diagnostic test strip of claim 1, wherein there are 0130 For oral fluids such as saliva, samples may be two or more boundary projections on the same side of the obtained by contacting an embodiment with a patients carrier strip and further wherein at least one each of the two US 2016/03 13307 A1 Oct. 27, 2016

or more boundary projections are substantially at the oppo 16. The diagnostic test strip of claim 1, wherein the sides site ends of the carrier strip and the opening in each one of the one or more boundary projections slope downward faces toward the nearest end. towards the opening of the boundary projection. 7. The diagnostic test strip of claim 1, wherein there are 17. The diagnostic test strip of claim 1, wherein the sides two or more boundary projections on the same side of the of the one or more boundary projections extend Substantially carrier strip further wherein at least one each of the two or for the entire length of the one or more test pads. more boundary projections are Substantially at the opposite 18. The diagnostic test strip of claim 1, wherein the sides ends of the carrier strip and the opening in each one faces of the one or more boundary projections extend partially away from the nearest end. along the length of the one or more test pads inside and 8. The diagnostic test strip of claim 1, wherein there are closest to the end the boundary projection. two or more boundary projections on the same side of the 19. The diagnostic test strip of claim 1, wherein there are carrier strip and further wherein at least one each of the two two test pads. or more boundary projections are substantially at the oppo 20. The diagnostic test strip of claim 1, wherein there is site ends of the carrier strip and the opening in one faces one test pad. away from the nearest end and the opening in the other faces 21. The diagnostic test strip of claim 1, wherein the one toward the nearest end. or more test pads each contain a test reagent. 9. The diagnostic test strip of claim 1, wherein there are 22. The diagnostic test strip of claim 1, wherein the one two or more boundary projections on the same side of the or more test pads each contain a different test reagent. carrier strip and further wherein at least two of the two or 23. The diagnostic test strip of claim 1, wherein the one more boundary projections are placed Substantially in the or more test pads are on the same side of the carrier strip and contain two test reagents on different regions of the test pad. middle of the carrier Strip and the opening in each one faces 24. The diagnostic test strip of claim 23, wherein the test away from each other and toward the nearest end. reagents are different. 10. The diagnostic test strip of claim 1, wherein there are 25. The diagnostic test strip of claim 23, wherein the two two or more boundary projections on the same side of the test reagents are arranged in a pattern to give a signal to the carrier strip and further wherein at least two of the two or USC. more boundary projections are placed Substantially in the 26. The diagnostic test strip of claim 1, wherein the carrier middle of the carrier Strip and the opening in each one faces strip is porous. toward each other. 27. The diagnostic test strip of claim 1, wherein the carrier 11. The diagnostic test strip of claim 1, wherein there are strip is non-porous. two or more boundary projections on the same side of the 28. The diagnostic test strip of claim 1, wherein the one carrier strip and further wherein at least two of the two or or more test pads are porous. more boundary projections are placed Substantially in the 29. The diagnostic test strip of claim 1, wherein the one middle of the carrier Strip and the opening in each one faces or more test pads are non-porous. the same end of the test strip. 30. The diagnostic test strip of claim 1, wherein there are 12. The diagnostic test strip of claim 1, wherein there are at least two or more test pads each with a different test two or more boundary projections on the same side of the reagent and each reagent tests for a different marker on the carrier strip and further wherein at least one of the two or same analyte. more boundary projections is placed Substantially in the 31. The diagnostic test strip of claim 1, wherein at least middle of the carrier strip and the other is placed substan one test pad further contains a signaling reagent. tially at one end of the test strip and the opening in each one 32. The diagnostic test strip of claim 1, further comprising faces away from each other and toward the nearest end. a Substantially non-porous handle attached on one end or 13. The diagnostic test strip of claim 1, wherein there are side of the carrier strip. two or more boundary projections on the same side of the 33. The diagnostic test strip of claim 1, wherein the carrier carrier strip and further wherein at least one of the two or strip is Substantially square shaped. more boundary projections is placed Substantially in the 34. The diagnostic test strip of claim 1, wherein the carrier middle of the carrier strip and the other is placed substan strip is Substantially circularly shaped. tially at one end of the test strip and the opening in each one 35. The diagnostic test strip of claim 34, wherein there are faces toward the same end of the carrier strip. at least two boundary projections on the same side of the 14. The diagnostic test strip of claim 1, wherein there are carrier Strip and the projections are placed Substantially two or more boundary projections on the same side of the opposite on Substantially the edge of the circularly shaped carrier strip and further wherein at least one of the two or carrier strip. more boundary projections is placed Substantially in the 36. The diagnostic test strip of claim 35, wherein the middle of the carrier strip and the other is placed substan openings in the boundary projections face toward the edge tially at one end of the test strip and the opening in each one of the carrier strip. faces toward the same side of the carrier strip. 37. The diagnostic test strip of claim 35, wherein the 15. The diagnostic test strip of claim 1, wherein there are openings in the boundary projections face away from the two or more boundary projections on the same side of the edge of the carrier strip. carrier strip and further wherein at least one of the two or 38. The diagnostic strip of claim 35, further wherein there more boundary projections is placed Substantially in the is at least one boundary projection in the Substantially center middle of the carrier strip and the other is placed substan of the carrier strip. tially at one end of the test strip and the opening in each one 39. The diagnostic test strip of claim 35, further wherein faces Substantially toward opposite sides of the carrier strip. there are at least two boundary projections on the same side US 2016/03 13307 A1 Oct. 27, 2016

of the carrier strip each substantially in the center of the 46. The diagnostic test strip of claim 1, wherein the carrier carrier strip and the openings in each one face Substantially strip is Substantially oval shaped. away from each other. 47. A method for detecting one or more analytes in a 40. The diagnostic test strip of claim 34, wherein there are patient sample, comprising: three or more boundary projections on the same side of the a) contacting the test strip of claim 1 with a patients carrier strip placed substantially at the edge of the carrier tongue so that the patients tongue contacts the one or strip and Substantially evenly spaced from each other. more test pads; and 41. The diagnostic test strip of claim 40, wherein the b) reading the results from the test strip. openings in the boundary projections face Substantially 48. The method of claim 47, further comprising contact toward the edge of the carrier strip. ing the test strip with one or more signaling reagents so that 42. The diagnostic test strip of claim 40, wherein the the one or more reagents contact the one or more test pads. openings in the boundary projections face Substantially 49. The method of claim 47, wherein the test strip is away from the edge of the carrier strip. contacted with the top and the sides of the patients tongue 43. The diagnostic test strip of claim 40, wherein the in a substantially back and forth motion from substantially openings in the boundary projections alternate in facing the tongue tip to Substantially the back of the tongue. Substantially to and away from the edge of the carrier strip. 50. The method of claim 47, wherein the test strip is 44. The diagnostic test strip of claim 33, comprising two contacted with the top and the sides of the patients tongue or more concentric circles of multiple boundary projections in a substantially side-to-side motion along the width of the on the same side of the carrier strip substantially evenly tongue. spaced from each other. 51. The method of claim 47, wherein the test strip is 45. The diagnostic test strip of claim 1, wherein there are contacted with the top and the sides of the patients tongue two or more boundary projections and at least one is on the in a Substantially circular motion. opposite side of the others. k k k k k