Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Catalog No. Product Name Note
ABT-IDT-A13 H.pylori Whole Blood Strip CE
ABT-IDT-B13 H.pylori Whole Blood Cassette CE
Accu-Tell ® Rapid H. Pylori test is a rapid test for the qualitative detection of IgG antibodies specific to Helicobacter pylori in human serum, plasma and whole blood specimens. This test kit is intended as an aid in the diagnosis of H. pylori infection in patients with gastrointestinal symptoms. For IN VITRO Diagnostic use only.
Gastritis and peptic ulcers are one of the most common human diseases. Since the discovery of H. pylori (Warren & Marshall, 1983), many reports have suggested that this organism is one of the major causes of ulcer diseases (Anderson & Nielsen, 1993; Hunt & Mohammed, 1995; Lambert et al. 1995) and stomach cancer (Eurogast Study Group, 1993). Although the exact role of H. pylori is not fully understood, the eradication of H. pylori has been associated with elimination of ulcer diseases.
The human serological responses to infection with H. pylori have been demonstrated (Varia & Holton, 1989; Evans, et al., 1989). The detection of the specific IgG antibodies to H. pylori has been shown to be an accurate method for detection of H. pylori infection in symptomatic patients. However, H. pylori may colonize in some asymptomatic persons.
Accu-Tell ® Rapid H. pylori test is intended for use in the detection of the IgG antibodies specific to H. pylori in serum, plasma or whole blood. This information can be used by the physician and the patient for ulcer disease management.
The Accu-Tell ® Rapid H. pylori test has been designed to detect the H. pylori infection through visual interpretation of color development in the test device, which is a sandwich solid phase dye conjugate non-enzyme immunoassay. The membrane was precoated with H. pylori antigens on the test band region and donkey-anti-goat antibody on the control band region. During the test the diluted patient blood sample is allowed to react with a coloured conjugate (H. pylori antigens-colloid gold conjugate), which was pre-dried on the pad inside the test cassette. The mixture then moves on the membrane chromatographically by a capillary action. When H. pylori specific IgG antibodies are present in sample, a color band with a specific antigen-antibody-coloured conjugate complex will form at the test region of the membrane. On the other hand, a colour band will always appear at the control region. This control band serves as a procedural indicator for the proper functioning of the device. A distinct colour development in the test band region indicates a positive result and absence of a colour band in the test region suggests a negative result.
The test kit is to be stored refrigerated (2-8°C) or at room temperature (up to 30°C) in the sealed pouch for the duration of the shelf-life.
1. FOR in-vitro diagnostic use only.
2. Do not use test kit beyond expiration date.
3. Do not mix reagents from different lots.
4. Do not open the foil pouch until ready to perform the test.
5. Do not use whole blood specimens which have been stored for more than three days.
6. Heat treated and/or contaminated sera may cause erroneous results.
7. Developer buffer, positive and negative controls contain sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides. When disposing of these solutions, always flush with copious amounts of water to prevent azide buildup.
8. Standard guidelines for handling infectious agents and chemical reagents should be observed throughout all procedures. All contaminated waste such as patient samples and used devices should be properly disposed of.
9. Warning: Potential Biohazardous Material
Each donor unit of human plasma or serum used in the preparation of the Positive and Negative Controls was tested by GMP-approved methods for the presence of anti-HIV-1/HIV-2, HBsAg and anti-HCV, and found to be negative. However, caution should be used when handling and disposing of these items at biosafety level 2.
Test device, patient’s samples, and controls should be brought to room temperature (20-30°C) prior to testing. Do not open pouches until ready to perform the assay.
For Serum or Plasma Samples
1. Remove the test device from its protective pouch (bring the device to room temperature before opening the pouch to avoid condensation of moisture on the membrane). Label the device with patient or control identification.
2. Dilute 20 μl serum/plasma sample in 150 μl Sample diluent and add all into the sample well of the device. Alternatively, add 20 μl serum sample into the sample well first and then add 3 or 4 drops of Sample diluent. Avoid dropping any solution in the observation window.
3. Observe the result within 10 minutes; do not read results after 15 minutes!
For Whole Blood Samples
1. Disinfect the fingertip with an alcoholic swab and squeeze it. Retrieve a blood drop from the finger tip by a lancet.
2. Wipe away the first drop of blood with a sterile swab.
3. Transfer the second drop of blood directly in the sample well.
4. Let the blood been soaked up and add 150μl or 3 drops of sample diluent to the sample well.
5. Read the result within 10 minutes. The time is calculated from the addition of the sample diluent. Do not read results after 15 minutes.
1. POSITIVE: Two pink-red colored bands appear. One in the control region (C) and one in the test region (T). When testing with strong positive samples, the intensity of the control band may be lighter than expected. Comparison of the line intensities is not recommended.
2. NEGATIVE: Only one pink-red colored band appears in the control region (C). No apparent faint pink to red colored band in the test region (T).
3. INVALID: A total absence of pink colored bands in both regions is an indication of procedural error or that test reagents may have deteriorated. Repeat the test with a new test device.
1. A procedural control is included in the test. A colored band appearing on the control region (C) of the membrane indicates proper performance of the test and the device.
2. A clear background in the result window is considered an internal negative control. However, when whole blood samples are tested, the background may appear slightly reddish due to the low level hemolysis of some red blood cells. This is acceptable as long as it does not interfere with the interpretation of test result. The test is invalid if the background fails to clear and obscures the reading of the result.
1. This test kit is to be used for the qualitative detection of IgG antibodies to H. pylori.
2. This test kit should be used for symptomatic individuals with gastrointestinal disorders. Diagnosis of gastritis and/or peptic ulcers should be made by confirmation with other clinical findings.
3. A positive result suggests the presence of IgG to H. pylori and does not allow one to distinguish between active infection and colonization by H. pylori. It does not necessarily indicate that a gastrointestinal disease is present.
4. A negative result does not rule out infection by H. pylori because the antibody to H. pylori may be absent or may not be present in sufficient quantity to be detected.
5. Serum samples from patients infected with C. jejuni may produce a low level of cross-reactivity in this test.
1. Anderson, L.P. and Nielsen, H., (1993) Peptic ulcer: an infectious disease: Ann.Med. 25: 563-568.
2. 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.
3. Eurogast Study Group, LANCET 1993:341:1359-62.
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. Tytgat G.N.J. and Rauws, E.A.J. (1989) The role of Campylobacter pylori in gastroduodenal diseases: a ÒbelieverÕsÓ point of view, Gastroenterol. Clin. Biol. 13:118-121B.
7. Vaira, D. and Holton, J. (1989) Serum immunoglobulin G antibody levels for Campylobacter pylori diagnosis, Gastroenterology. 97:1069-1071.
8. Warren, J.R. and Marshall, B. (1983) Unidentified curved bacillus on gastric epithelium in active chronic gastritis, Lancet. 1: 1273:1275.
The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.
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