ACCU-TELL HBCAB SERUM / WHOLE BLOOD TEST
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-A10 HBcAb Serum Strip
ABT-IDT-B10 HBcAb Serum Cassette
ABT-IDT-A82 HBcAb Whole Blood Strip
Accu-Tell ® Rapid HBcAb Test is a rapid, Rapid, immunochrom-atographic assay for the detection of hepatitis B core antibody (HBcAb) in human serum. The test is indicated for the screening of licensed blood and blood products intended for transfusion and as an aid in the diagnosis of ongoing or previous hepatitis B viral infection. The test provides a visual, qualitative result, and is intended for professional use.
Accu-Tell ® HBcAb determinations can be used to monitor the progress of the hepatitis B viral infection. HBcAb is found in serum or plasma shortly after the appearance of hepatitis B surface antigen (HBsAg) in acute hepatitis B and will persist after the disappearance of HBsAg.1-3 and before the appearance of detectable anti-HBsAg antibody. Therefore, in the absence of HBsAg and anti-HBsAg, HBcAb may be the only serological marker of recent hepatitis B infection and potentially infectious blood.4-6
The Accu-Tell ® Rapid HBcAb Test is a competitive colloidal gold enhanced immunoassay for the determination of anti-HBc antigen(HBcAb) in human serum or plasma. The nitrocellulose membrane was immobilized with anti-HBc antibody on the test region. During the assay, the presence of HBcAb in the specimen will compete with anti-HBc antibody immobilized on nitrocellulose membrane for a limited number of colored HBcAg:colloidal gold. For a negative result, a color band with the specific antibody-HBcAg-colored conjugate complex will form on the membrane. Absence of this colored band in the test region suggests a positive result, i.e., the colored HBcAg:colloidal gold is neutralized by HBcAb existed in the specimen. 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 Laboratories or other equivalent guidelines.
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 using a suitable disinfectant, such as 1% Sodium Hypochlorite for nonradioactive material11 or 2% Glutaraldehyde for spills containing radioactive material.
4. Devices used for the assay should be sterilized before being disposed.
5. Do not use the test card or reagent 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 its foil pouch.
2. Label the test cassette with identification of each specimen or control on blank pad of the test ca ssette with a pen or sticker.
3. Dispense 100μl (3 drops) of the specimen or control into the sample well on the cassette.
4. Wait 15 minutes and read results.
For Test Strip:
1. Remove the test strip from the foil pouch and place on a clean dry surface.
2. Identify the test strip for each specimen or control.
3. Apply at least 80μl of specimen to the sample pad behind the ( ↓↓↓ ) mark at the bottom of test strip.
4. 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 read results after 20 minutes.
Positive: Only one colored band appears on the control region.
Negative: In addition to the control band, a distinct colored band also appears on the test region.
Invalid: Neither test band nor control band appears. The specimen should be tested again.
The Rapid HBcAb Test is a screening test, The test procedure is limited to the detection of HBcAb in serum or plasma. It is recognized that presently available methods for HBcAb 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.
Accu-Tell ® Rapid HBcAb Test showed equivalent detectability to EIA immunoassay for HBcAb. A result of 99.5% correlation to EIA test was determined by a clinical study of 1139 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. Hoofnagle, J. H., Gerety R. J. and Barker. L. F., Antibody to hepatitis-B-virus core in man. Lancet, II.:869-873, 1973.
2. Szmuness, W., Hstevens, C. E., and Prince. A. M., Antibody against the hepatitis type B core antigen, Am. J. Epidemiol. 104:256-262, 1976.
3. Krugman, S., Overby. L. R., Mushawar, I. K., Ling, C.M., Frosner, G.G., and Deinhardt. F., Viral hepatitis, type B: Studies on natural history and prevention re-examined. N. Engl. J. Med., 300:101-106,1979
4. Lander, J. J., Gitnick, G. L., Gelb, L. H., and Aach. R. D., Anticore antibody screening of transfused blood. Vox Sang. 34:77-80. 1978
5. Hoofnagle, J. H., Seeff. L. B., Bales, Z.B., Zimmerman, H. J., and the Veterans Adiministration Hepatitis cooperative Study Group. Type B hepatitis after transfusion with blood containing antibody to hepatitis B core antigen. N. Engl. J. Med., 298:1379-1383. 1978.
6. Katchaki, J. N., Siem, T. H., Brouwer, R., Brandt, K. H., and Van Der Waart, M., Detection and significance of anti-HBc in the blood bank’ preliminary results of a controlled prospective study. J. Virol. Methods, 2:119-125, 1980.
7. 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.
8. World Health Organization. Laboratory biosafety manual. Geneva. World Health Organization, 1983.
9. 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.
10. Centers for Disease Control. Recommendation for preention of HIV transmission in health care setting. MMWR 36, Supplement No. 2S, 1987.
11. 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.
12. 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., 18:535-538, 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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