One Step Fecal Occult Blood Test

One Step Fecal Occult Blood Test Control region: Goat anti-mouse (IgG) polyclonal antibody 1. Remove the test device from its foil pouch by tearing along the notch and use it as soon as possible. Cat. No: Test region: mouse monoclonal anti-hemoglobin 2. Specimen collection. See also SPECIMEN antibody A COLLECTION INTENDED USE 3. Shake the sample collection device several times. Labeled Antibody: 4. Holding the sample collection device upright, carefully The One Step Cassette Style Fecal Occult Blood Test break off the tip of collection device. is a simple, direct binding immunoassay for the rapid Colloidal gold conjugate of monoclonal anti-hemoglobin 5. Squeeze 3-4 drops (~100ul) of the sample solution on the test sample pad, as in the illustration. and qualitative detection of human occult blood in antibody B 6. Read the test results after 5-10 minutes. It is important feces. The sensitivity is very high with the ability to that the background is clear before the result is read. Do detect 50 ng/mL of human hemoglobin in feces. In WARNINGS & PRECAUTION not read results after more than 20 minutes. addition, the accuracy of the test is not affected by interfering substances, and dietary restriction is not 1) In vitro diagnostic use for professional use only. break off squeeze necessary. For professional laboratory use only. 2) Do not use test kit beyond the expiry date. Dip stool sample shake the tip 3) The test device should not be reused. 4) Patient specimens may contain infectious SUMMARY AND EXPLAINATION agents and should be handled as though Stool sample capable of transmitting disease. Wear disposable The assay is designed to detect lower levels of gloves throughout the specimen collection and Break point colorectal bleeding than other biochemical detection assay procedures. Test reagent methods.

PRINCIPLE OF TEST MATERIALS PROVIDED

The test principle is an immunochromatographic 1) One Step Fecal Occult Blood Test sandwich method, which employ two specific 2) Sample Collection Device with buffer monoclonal antibodies to selectively identify 3) Instructions for use hemoglobin in test samples. The result is very specific, and easier to interpret than those of guaiac- C T based test. SPECIMEN COLLECTION

The assay is conducted by adding diluted stool Collect stool sample by using the special sample specimen to the test device and observing the collection device provided. First, unscrew the top formation of colored lines. The specimen migrates of the sample collection device, take out the INTERPRETATION OF RESULTS via capillary action along the membrane to react sample collection stick, and collect the sample by with the colored conjugate. Positive specimens react dipping the stick into 3 different places of the stool  N Negative: Only one colored band appears on with the specific colored antibody conjugates and sample. Then, put the sample collection stick back the control (C) region. No apparent band on the form a colored line at the test line region of the in the sample collection device and screw together test (T) region. This means that FOB level is membrane. Absence of this colored line suggests a tightly. below 50ng/mL. negative result. To serve as a procedural control, a colored line will always appear at the control line If the sample cannot be tested on the day of  Positive: In addition to a pink colored control region if the test has been performed properly. collection, store the stool sample at 4°C. Stir and (C) band, a distinct pink colored band will also bring the specimen to room temperature before appear in the test (T) region. This indicates that REAGENTS testing. the FOB concentration is more than 50ng/mL. Please consult your physician to perform a much Coated Antibodies: more detailed examination.

DIRECTIONS FOR USE

Revision date: March 2006  Invalid: None of line appears or no line appears findings have been evaluated. This test cannot to normal stool extracts at both 0 and 50 ng/ml in the control (C) region. An invalid result may be intended to replace G.I. fibroscope, endoscopy, human hemoglobin and the results were due to improper testing procedures or colonoscopy, or x-ray analysis. negative and positive respectively. In addition, deterioration of the kit components. Repeat the the study was repeated with tissue extracts of assay sequence using a new device. 2. This test is limited to the detection of beef, pig, rabbit, sheep, fish, chicken and goat Fecal Occult Blood in human stool sample only. and no cross reactivity was evident. Lastly, toilet C T C T C T C T water with the presence of various cleaners 3. Although the test is highly accurate in (enzymatic to chlorax based) was added to test detecting human hemoglobin, a low incidence device and results were as expected following Negative Positive Invalid of false positive results may occur. In addition, the same protocol as above. because many bowl lesions, indulging some STORAGE AND STABILITY polyps and colorectal cancers, may bleed A performance study was completed to intermittently or not at all, occult blood may investigate the interference of dietary The test kit can be stored at temperatures not be uniformly distributed throughout a fecal substances on the FOB test. Aqueous extracts of between 2 to 30C in the sealed pouch to the sample. Thus rest results may be negative raw broccoli, cauliflower, cantaloupe, date of expiration. The test kit should be kept even when disease is present. horseradish, red radish, parsnip, and turnip were away from direct sunlight, moisture and heat. added to test device. Also included were dietary The expiration dating was established under PERFORMANCE CHARACTERISTICS iron, vitamin C and horseradish peroxidase. The these storage conditions. dietary substance extracts were added to normal Accuracy stool extracts at both 0 and 50 ng/ml human QUALITY CONTROL hemoglobin and the results were as expected. All This test is sensitive for 50 ng/mL human of the 0 ng/ml Hb samples spiked with interfering A colored line appearing in the control region (C) hemoglobin in stool sample. 100 spiked stool substances were negative, while all of the is the internal procedural control. It confirms samples with concentrations at 0 ng, 25 ng, 50 50ng/ml Hb spiked samples were positive. sufficient specimen volume and correct ng, 75 ng, 100 ng / ml were tested. The results in procedural technique. A clear background is an Table 1 showed that the cutoff was the expected internal negative background control. If the test 50 ng/mL. Moreover, two types of abnormal Method Comparison is working properly, the background in the result blood (Thalassemia and Sickle Cell) were tested area should be white to light pink and not and no false negative issues were raised as To establish the sensitivity and specificity of IND interfere with the ability to read the test result. results were as expected. Diagnostic One Step FOB Test kit relative to other rates of qualitative FOB tests, 648 clinic External controls may also be used to assure that Table 1: Cutoff Concentration for IND FOB Test samples were studied. Another commercially the reagents are working properly and that the available qualitative test kit (Syntron Bioresearch assay procedure is followed correctly. It is Hemoglob 0 25 50 75 100 FOB) was used to compare with IND Diagnostic recommended that a control be tested at regular in (ng/mL) One Step FOB Test kit for relative sensitivity and intervals as good laboratory testing process. # of 20 20 20 20 20 specificity in 648 stool samples. Only 2 samples Samples were discordant, the agreement is 99.67%. Users should follow the appropriate federal, Negative 20 20 2 0 0 (Table 1) state, and local guidelines concerning the Postive 0 0 18 20 20 running of external quality controls. Interfering Substances Table 1: Comparison between Syntron Bioresearch FOB and IND FOB Test LIMITATIONS A performance study was completed to investigate the cross reactivity of other species 1.As with all diagnostic tests, all results must be of hemoglobin and tissue extracts on the FOB considered with other clinical information Test. The hemoglobin species of bovine, equine, IND kits Subto available to the physician. A definite clinical pig, rabbit, sheep, fish, chicken, and goat origin tal diagnosis should only be made by the was added to the test device and the results as + - physician after all clinical and laboratory expected. Hemoglobin of the species was added Syntron + 28 0 28 kits - 2 618 620 Subtotal 30 Revision618 date: March648 2006 References:

Gorzynski TJ, Krco CJ, David CS., An idiotope expressed on a monoclonal antibody specific for human haemoglobin beta chain and naturally occurring immunoglobulin(s). J Immunogenet. 1985 Dec;12 (6):281-91.

Gorzynski TJ, Krco CJ, David CS., The Hb-2d cross-reactive idiotype. A common idiotype expressed by monoclonal and polyclonal antibodies to human haemoglobin. J Immunogenet. 1985 Dec;12(6):267-79.

GRAPHICAL SYMBOLS USED

Storage temperature Lot number 0088 In vitro diagnostic device Expiry date

Read instruction before use Manufacturer D Do not reuse

Revision date: March 2006