María de Luna 11, nave 13 CEEI Aragón, 50018 Zaragoza (Spain) Telephone: +34 976 512 887 NOTA: Documentación en www.alphasip.es español (Página 11) INTENDED USE Urine DrugSIP® cassette is an in vitro diagnostic testing device used by healthcare professionals for diagnostic purposes in patient treatment set up. Urine DrugSIP® cassette incorporates collection and testing for the detection of drugs and their principle metabolites in human urine specimens. DrugSIP® is represented by a separate test line in the test window of the cassette). urine cassette uses one-step, lateral flow immunoassays for the simultaneous detection® cassette of up is intendedto ten (10) for drug use analytesin the qualitative in urine (eachdetections analyte of the following drugs/drug metabolites, or for specimen validity testing in human urine at the following levels: All configurations of the product are covered by these product instructions. Urine DrugSIP Compound Abbreviation Level (ng/mL) Amphetamine (d-amphetamine sulphate) AMP 1000 Barbiturates (butalbitol) BAR 300 Benzodiazepines (oxazepam) BZO 300 Buprenorphine BUP 12,5 Cocaine (benzoylecgonine) COC 150*/300 MDMA ((+/-)3,4 methylenedioxy-methamphetamine) MDMA 1000 Methadone MTD 300 Methamphetamines ((+)methamphetamine HCI) MET 1000 Opiates (morphine-3-b-D-glucuronide) OPI 300/2000* Oxycodone OXY 100 Phencyclidine (phencyclidine HCI) PCP 25* Propoxyphene/Norpropoxyphene PPX 300 THC 50* TCH/CannabinoidsTricyclic Antidepressants (11-nor-∆9-THC-9-carboxylic-acid) (nortriptyline) TCA 1000 *Screening cut-off concentrations recommended by Substance Abuse Mental Health Services Administration (SAMHSA). Urine DrugSIP® cassette provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug detection test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) is the recommended confirmatory method. SUMMARY AND EXPLANATION Urine DrugSIP® of amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine, MDMA (Ecstasy), methadone, methamphetamines, opiates, oxycodone, phencyclidine, propoxyphene, cassette incorporates THC/Cannabinoids competitiveC.D.Products andimmunoassays tricyclic antidepressants utilizing highly in specific urine. reactions betweenS.A. antibodies and antigens for the detection PRINCIPLES OF THE TEST Urine DrugSIP® cassette is a simple, qualitative, visually read test that detects drug use in urine samples. Each Urine DrugSIP® cassette contains test sites with drugs or metabolites that may be present in the urine specimen. The test strip consists of a membrane strip with an immobilized drug conjugate.strips for the A colloidal above mentioned gold-labeled drugs antibody that are complex one-step is immunoassays.dried at one end The of thespecifically membrane. labeled A control drug (drug line, comprisedconjugate) ofcompetes a different for antibody/antigenantibody binding therefore, it should be present in all reactions. reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of a drug analyte in the urine specimen, and In the absence of any drug in the urine specimen, the colloidal gold-labeled antibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. An antibody-antigen reaction occurs forming a visible line in the “test” area. The formation of two (2) visible lines (control and test line) occurs when the test is negative or bellow the cut-off for the drug. When a drug analyte is present in the urine specimen, the drug or metabolite will compete with the immobilized drug conjugate in the test area for binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. The formation of one (1) visible line (control line, no test line)the antibody is indicative binding of sitesa preliminary in the colloidal positive gold-labeled result for antibody the drug. complex. If a sufficient amount of drug analyte is present, it will fill all of the available 1 REAGENTS AND MATERIALS SUPPLIED Each case of Urine DrugSIP® cassette contains: 1. Fifty (50) Urine DrugSIP® cassette tests. Each Urine DrugSIP® cassette is packaged in a sealed foil pouch containing: a. One (1) Urine DrugSIP® cassette with one (1) or more channels containing a test strip that has immunoassays for up to ten (10) or pouch indicated different drugs. Each test strip is comprised of a membrane with two (2) attached absorbent pads and a pad containing the immobilized colloidal gold-labeled antibody complex. The upper pad acts as a reservoir for the specimen after it migrates through the membrane. The test lines contain a carrier-drug conjugate for the individual analytes, dried on the membrane. The control line, containing goat anti-mouse IgG, is placed above the test lines on the membrane. b. Desiccant. 2. Pipettes (if using the pipette method). 3. A plastic base to adapt the Urine DrugSIP® cassette to DrugSIP® Multi Analyzer. In some references the bases are present in the individual pack or in the box of 50 cassettes. 4. Fifty (50) protect stickers to avoid of contamination the plastic base of the cassette after urine deposition. 5. Product instructions. MATERIALS REQUIRED BUT NOT PROVIDED Manual test performance: timer Automatic test performance: DrugSIP® Multi Analyzer electronic device Collector urine container: DrugSIP® urine collection kit WARNINGS AND PRECAUTIONS For in vitro diagnostic use only. For professional use. Follow proper handling and disposal procedures. While the Centers for Disease Control (CDC) has stated that “Universal precautions do not apply to feces, nasal secretions, sputum, sweat, tears, urine and vomitus unless they contain visible blood”, the use of gloves is recommended for handling of all samples and is good hygienic practice. Urine DrugSIP® cassette may be disposed of in a regular trash receptacle without any special handling. Do not use if foil pouch seal is not intact (seal broken, tears, holes, etc…) Do not used if beyond the expiration date printed or embossed on the pouch. The expiration date is formatted as YYYY/MM, e.g. 2015/01 means the kits should not be used after the end of January, 2015. STORAGE The Urine DrugSIP® cassette device should be stored at room temperature [59º to 86º F or 15º to 30ºC) or refrigerated (36º to 46ºF or 2º to 8ºC). If refrigerated, allow test device to warm up to room temperature before conducting any testing. SPECIMEN COLLECTION AND HANDLING Use fresh urine specimens. Urine specimens do not require any special handling or pretreatment. AlphaSIP provided the product DrugSIP® urine after collection. If necessary, urine specimens may be refrigerated at 2° to 8°C for up to two (2) days. Handlecollection and kit dispose which containsof urine specimens twenty-five according or fifty (25-50) to established sterile cups protocols. and contamination indicator strips. It is best to test urine specimens immediately Avoid contact with skin. Avoid cross-contamination of urine specimens by using a new container for each urine specimen using DrugSIP® urine collection kit PROCEDURES C.D.Products S.A. Dip Procedure 1. Instruct donor to provide adequate sample volume. Urine DrugSIP® cassette dip procedure can be done with as little as three (3) mL in a collection cup like provided in the DrugSIP® urine collection kit. If an adequate sample is not provided, see the Pipette Procedure. 2. Verify the foil pouch is intact. Verify the product is within the expiration date as indicated on the pouch. When an acceptable sample is obtained, Urine DrugSIP® cassette may be removed from the foil pouch. 3. above the dip line. 4. RemoveInsert the the bottom Urine of DrugSIP test cassette® into the urine sample up to the dip line for three to five (3-5) seconds. Do not allow urine to touch the cassette urine for the entire test period, provided the urine does not touch the cassette above the dip line. 5. Allow the test to proceed until cassette a reddish-purple from the sample control and line lay appears flat across and the testtop ofbackground the cup or clears. on a flat The surface. control The line, cassette C , is the can uppermost be left in linethe 6. Read results as explained under Interpretation of Results. in the channel. Once the control line is visible the test is ready to interpret; typically this occurs in three to five (3-5) minutes. Pipette Procedure/Low volume 1. Verify the foil pouch is intact. Verify the product is within the expiration date as indicated on the pouch. When an acceptable sample is obtained, Urine DrugSIP® cassette may be removed from the foil pouch. 2. Lay Urine DrugSIP® ® cassette. 3. Using a pipette, apply three (3) drops of urine (approximately 120 µL) to the sample well at the bottom of each Urine DrugSIP® cassette. 4. Allow the test to proceed cassette undisturbed flat. An absorbent until a reddish-purplepad may be placed control under line the appears Urine DrugSIP and the test background clears. The control line, C, is the minutes. 5. Readuppermost results line as explainedin the test underchannel. Interpretation Once the control of Results. line is visible, the test is ready to be interpreted; typically this occurs in three to five (3-5) 2 INTERPRETATION OF RESULTS -DRUG TEST The test results may be interpreted once the control line(s) have formed and the background on the test strip(s) has cleared. This will occur in blindness will not affect reading the results of the test. The test results are stable for up to six (6) hours. approximately three to five (3-5) minutes. The test results are determined by the presence or absence of the test and control lines, therefore color Test Valid The control line will form in the control area labeled, C, on the cassette. The control line is the uppermost line appearing in each test channel. Before reading the test result lines, verify that the control line has formed in each test channel, indicating that the test is valid.