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OneStep H Pylori #118561 Test Atlas Link InstaTest H. Pylori OneStep H. Pylori Serum Test SPECIMEN COLLECTION 1. 2. Catalog # 118561-50 (50 tests) Read the instruction before performing assays. Follow the procedures during testing. 3. Serum specimen may be collected following standard clinical procedure. Serum specimens can be stored at room temperature (20°C to 28°C) for 4 hours, at 2o-8oC for 48 hours, and at -20°C or lower for prolonged storage. Repeatedly frozen and thawed specimens are not recommended for this assay. Any sediment in serum specimens should be removed by centrifugation. Avoid using any turbid specimens, which may be contaminated by microorganisms. SUMMARY The infection of Helicobacter pylori 1 (H. pylori, spiralshaped bacterium) is associated with a variety of gastrointestinal diseases, such as stomach ulcer, chronic active gastritis and gastric, duodenal, and gastric adenocarcinoma2,3,4,5,6,7,8. Antibodies to H. pylori are developed in Individuals infected with H. pylori as a serological response9,10. Detecting these specific antibodies to H. pylori can be used as a qualitative assay in the diagnosis of H. pylori infection. It may be used either as an adjunct to endoscopy or as an alternative measure in symptomatic patients. PRECAUTIONS 1. 2. 3. 4. FOR IN VITRO USE ONLY. Do not use test kit beyond expiration date. Do not open the test device foil pouch until you are ready to perform the test. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results. PROCEDURE PRINCIPLE The Atlas Link Diagnostics H. pylori one-step assay is a lateral flow, chromatographic immunoassay (CIA), containing filter membrane pre-coated with H. pylori specific antigens and colored gold colloidal reagents labeled with H. pylori specific antigens. There are two regions on the membrane of the test strip, test region (T) and control region (C). A T line, the burgundy colored band in the test region of membrane, will be developed rapidly (after 30 seconds) when antibodies to H. pylori present in specimen. If antibodies to H. pylori are not present, no T line will be developed in the test region. A C line, a burgundy colored band in the control region of the test strip, should always appear regardless of the presence of antibodies to H. pylori serving as a internal qualitative control of the test system. REAGENTS and MATERIALS 1. 2. Test Device: Each contains a test strip. Dilution buffer. 1. Refrigerated specimens or other materials should be equilibrated to room temperature right before performing testing. 2. Remove the device from its protective pouch. Label the device with specimen identification. 3. Add 20l of serum specimens into the sample well, Add four drops (about 200 l) of dilution buffer into the sample well. 4. Positive results may be observed as soon as 30 seconds after the specimen reaches the viewing window, depending on the concentration of antibodies to H. pylori in the tested specimen. To confirm negative results, total of 5 minutes, a complete reaction time is required. INTERPRETATION of RESULTS STORAGE The kit should be stored at room temperature (15-30°C) or refrigerator (2-8°C) in the sealed pouch with desiccant for the duration of the shelf life (18 months). Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA Phone: (703) 266-5667, FAX: (703) 266-5664 http://www.atlaslink-inc.com, [email protected] OneStep H Pylori #118561 Test 1. 1. 2. 3. C T C T C T S S S POSITIVE NEGATIVE INVALID Positive Two pink-rose bands appear: one in the test region (T) and in the control region (C). Negative One rose-pink band appears in the control region (C), with no band in the test region (T). Invalid There is no distinct color band visible both in the test region and in the control region, or there is a visible band only in the test region and not in the control region. The result is invalid due to deterioration of the test or improper test procedure. Repeat the test with a new Testing Device. LIMITATIONS 1. This test is a qualitative assay. To confirm diagnosis of gastritis and/or peptic ulcers, clinical findings need to be considered. 2. Serum samples from patients infected with C. Jejuni may have a low cross-reactivity with this test. 3. A negative result can not rule out H. pylori infection. Because the antibody to H. pylori may be absent or may be insufficient to be detected at the time of testing. Warren, J.R. and Marshall, B. (1983) Unidentified curved bacillus on gastric epithelium in active chronic gastritis (letters). Lancet 1: 1273-1275. 2. Anderson, L.P. and Nielsen, H., (1993) Peptic ulcer: an infectious disease? Ann. Med. 25: 563-568. 3. Dixon, ME, IV. (1991) Helicobacter pylori and peptic ulceration histpathological aspects. H. Gastro. Hepa. 6: 125-130. 4. Hunt, R.H. and Mohamed, A.H. (1995) The current role of Helicobacter pylori: eradication in clinical practice, Scand. J. Gastroenterol. 30 suppl 208: 47-52 5. Lambert, J.R.; Lin, S.K. and Aranda-Michel, J. (1995) Helicobacter pylori, Scand. J. Gastroenterol. 30 suppl. 208: 33-46 6. Warren, J.R. and Marshall, B. (1984) Unidentified curved bacillus in the stomach of patients with gastritis and peptic ulcer disease. Lancet 1: 1273-1275. 7. O’Connor, JH (1992) Helicobacter Pylori and gastric cancer: a review and hypothesis. Eur. J. Gastro. Hepa. 6: 103-109. 8. Parsonnet, J, et al.(1991) Helicobacter Pylori infection and the risk of gastric carcinoma. N. Eng. J. Med. 325. 1127-1131. 9. Vaira, D. and Holton, J. (1989) Serum immunoglobulin G antibody levels for Campylobacter pylori diagnosis. Gastroenterology 97: 1069-1071. 10. Evans, D.J., Evans, D.G., Graham, D.Y. and Klein, P.D. (1989) A sensitive and specific serologic test for detection of Campylobacter pylori infection. Gastroenterology 96: 1004-1008 REFERENCES Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA Phone: (703) 266-5667, FAX: (703) 266-5664 http://www.atlaslink-inc.com, [email protected]