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.
SPECIMEN COLLECTION (SERUM / WHOLE BLOOD)
Catalog No. Product Name
ABT-IDT-A9 HBeAg Serum Strip
ABT-IDT-B9 HBeAg Serum Cassette
ABT-IDT-A81 HBeAg Whole Blood Strip
ABT-IDT-B81 HBeAg Whole Blood Cassette
Accu-Tell ® Rapid HBeAg Test is a rapid, Rapid, immunochro-matographic assay for the detection of Hepatitis B e antigen (HBeAg) in human whole blood, serum or plasma. The test provides a visual, qualitative result, and is intended for professional use.
Accu-Tell ® Rapid HBeAg Test is a colloidal gold enhanced immunoassay for the determination of HBeAg in human whole blood, serum or plasma. The nitrocellulose membrane was immobilized with mouse anti-HBeAg McAb on the test region. During the assay the serum specimen is allowed to react with the colored conjugate(antibody-colloidal gold conjugate); the mixture then migrate chromatographically on the membrane by the capillary action. For a positive result, a color band with the specific antibody-HBeAg-colored conjugate complex will form on the membrane. Absence of this colored band in the test region suggests a negative result. To serve as a procedural control, a colored band at control region always appears.
It is recommended that all specimens be handled in accordance with Biosafety Level 2 practices as described in the CDC NIH Publication, Biosafety in Microbiological and Biomedical Laboratories1 or other equivalent guidelines.2-3
1. For in vitro diagnostic use only.
2. All serum specimens should be treated as infectious material. Do not contact the test card without wearing safety gloves.
3. Clean and disinfect all spills of specimens and reagents using a suitable disinfectant,4 such as 1% Sodium Hypochlorite
4. Devices used for the assay should be disposed of as bio-hazardous waste.
5. Do not use beyond expiration date.
SPECIMEN COLLECTION
1. Either serum or plasma may be used in the test.
2. Anticoagulants typically used for blood collection do not interfere with this test. Remove the serum or plasma from the clot or red cells respectively, as soon as possible to avoid hemolysis.
3. Specimens that are apparently hemolyzed, extremely thickened or with very high fat level are NOT suitable for the assay. Specimens containing particulate matter may give inconsistent results and should be clarified before testing.
4. If specimen are to be stored, they should be refrigerated at 2-8oC . For long term storage(over 3 days), the specimens should be frozen.
5. If specimens are to be shipped, they should be packed in compliance with federal regulation covering the transportation of etiologic agents.
6. Avoid frequent (more than 3 times) thaw-and-freeze of specimens.
7. Up to 1% of sodium azide can be added to specimen as preservative without affecting the results of assay.
SPECIMEN COLLECTION
Whole Blood:
1. Collect whole blood specimens following regular clinical laboratory procedures.
2. Heparinized capillary tubes must be used for collecting whole blood samples. Do not use hemolyzed blood samples.
3. Whole blood specimens should be used immediately after collection.
Serum or Plasma：
1. Collect serum or plasma specimens following regular clinical laboratory procedures.
2. Only those specimens that are clean, clear and with good fluidity can be used for the assay.
3. Those specimens that are apparently hemolyzed, extremely thickened or with very high fat level are NOT suitable for the assay.
4. Storage: A specimen should be refrigerated if not used the same day of collection. Specimens should be frozen if not used within 3 days of collection. Avoid freezing and thawing the specimens more than 2-3 times before use. 0.1% of sodium azide can be added to specimen as preservative without affecting the results of the assay.
Bring all reagents and specimens to room temperature.
For Test Cassette:
1. Remove the test cassette from the foil pouch and place on a clean dry surface.
2. Identify the test cassette for each specimen or control.
3. Dispense 100μl (3drops) of the specimen or control into the sample well on the cassette.
4. Interpret test results at 15 minutes.
For Test Strip:
1. Bring all reagents and specimens to room temperature.
2. Remove the test strip from the foil pouch and place on a clean dry surface.
3. Identify the test strip for each specimen or control.
4. Apply at least 80μl of specimen to the sample pad behind the ( ↓↓↓ ) mark at the bottom of test strip.
5. Interpret test results at 15 minutes.
Caution: Use a disposable pipette tip for each transfer to avoid cross-contamination
It is recommended to run a known positive control and negative control in each performance to ensure the assay procedure.
Do not interpret the results after 20 minutes.
Positive: In addition to the control band, a purplish red test bandalso appears on the test region.
Negative: Only one purplish red test band appears on the control region.
Invalid: Neither test band nor control band appears. The specimen should be tested again.
The Rapid HBeAg Test is a screening test, and the procedure is limited to the detection of HBeAg in human whole blood, serum or plasma. It is recognized that presently available methods for HBeAg detection may not detect all potentially infectious units of blood or possible cases of hepatitis B. False reactive results may be obtained with any diagnostic test.
The Accu-Tell ® Rapid HBeAg Test showed equivalent detectability to EIA immunoassay for HBeAg. A result of 99% correlation to EIA test was determined by a clinical study of 1000 specimens.
The test kit can be stored at room temperature (2 to 30℃) in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat.
1. U. S. Department of Health and Human Services. Biosafety in microbilogical and biomedical laboratories. HHS Publication(NIH) 88-8395. Washington: U.S. Government Printing Office, May 1988.
2. World Health Organization. Laboratory biosafety manual. Geneva. World Health Organization, 1983.
3. National Committee for Clinical Laboratory Standards. Protection of laboratory workers from infectious disease transmitted by blood, body fluids, and tissue: Tentative guideline. NCCLS Document M29-T. Villanova, PA.: NCCLS, 1989.
4. Cawley Centers for Disease Control. Recommendation for prevention of HIV transmission in health care setting. MMWR 36, Supplement No. 2S, 1987.
5. Sehulster, L. M., Hollinger, F. B., Dreesman. G. R., and Melnick, J. L., Immunological and biophysical alteration of Hepatitis B virus antigens by sodium hypochlorite disinfection. Appl. And Envir. Microbiol., 42:762-767, 1981.
6. Bond, W. W., Favero. M. S., Peterson, N. J., and Ebert, J. W., Inactivation of Hepatitis B virus by intermediate-to-high level dis-infectant chemicals. J. Clin. Microbiol., 18:535-538m 1983.
The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.
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