ACCU-TELL TB WHOLE BLOOD TEST (CE)

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

INTENDED USE

Accu-Tell ^® Rapid ANTI-TB (MYCOBACTERIUM TUBERCULOSIS) Whole Blood Test is a rapid, serological, immunochromatographic assay for the detection of antibodies to MYCOBACTERIUM TUBERCULOSIS (TB) antigen in human whole blood, serum or plasma. The test is used to obtain a visual, qualitative result and is intended for healthcare professional use.

Accu-Tell ^® Rapid ANTI-TB (Mycobacterium Tuberculosis) Test uses a double antigens “sandwich principle”¹ for the detection of Tuberculosis antibody in human whole blood, serum or plasma. Two recombinant Tuberculosis antigens (TB Ag 1&2) were mixed and immobilized on the test band region, and an antibody to Tuberculosis on the control band region of nitrocellulose membrane. Another Tuberculosis antigen (TB Ag 3), coupled with colloidal gold particles, is dried on a conjugate pad. During the assay, the specimen is allowed to react with the colored conjugate (antigen-colloid gold conjugate); the mixture then migrates chromatographically along the membrane by capillary action. If the specimen contains Tuberculosis antibody, the recombinant antigen immobilized on the membrane will capture the antibody-antigen-colloidal gold complex and form a colored test band on the membrane, indicating a positive result. Absence of the test band suggests a negative result. To serve as a procedural control, a colored band at control region always appears in the test area.

1.  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 Laboratories², or other equivalent guidelines.^3-4

2.  For in vitro diagnostic use only.

3.  All specimens should be treated as infectious material. Do not contact the test card without wearing safety gloves.

4.  Clean and disinfect all spills of specimens and reagents using a suitable disinfectant,⁵ such as 1% Sodium Hypochlorite.

5.  Devices used for the assay should be sterilized before being disposed.

6.  Do not use beyond expiration date.

Clean the area to be lanced with an alcohol swab and then take the sample. Whole blood, serum or plasma collected following regular clinical Laboratory Procedures can be used for this test.

1.  Dispense one drop (50ul) of whole blood, serum or plasma to the sample well of the test card.

2.  Add one drop of Sample Diluent to the sample well immediately after the specimen is added.

3.  Interpret test results at 15 minutes. Do not interpret the results after 30 minutes.

Positive: In addition to the control band, a distinct colored band also appears on the test region.

Negative: The control line appears in the test window, but the test line is not visible.

Invalid: No line appears in the control region. Under no circumstances should a positive sample be identified until the control line forms in the viewing area. If the control line does not form, the test result is inconclusive and the assay should be repeated.

A procedural control is included in the test. A red line appearing in the control region (C) is considered as internal positive procedural control. A clear background in the result window is considered as internal negative procedural control.

1. The assay should be performed in normal room temperature.

2. Test cards should be used immediately after being taken from the package. Avoid exposing the test strips in the air for too long before use.

3. The test cards may be stored under room temperature and dry condition. If refrigerated, the strips should be brought to room temperature before testing.

4.  Although the test is very accurate, a low incidence of false results can occur.

5. If negative or questionable results are obtained, the test should be repeated on a fresh whole blood, serum or plasma specimen using a new device.

6. A negative result does not rule out TB infection because the antibodies to TB may be absent at the time the specimen is taken or may not be present in sufficient quality to be detected at early stage of infection.

7. The test detects anti-TB antibody as a general indication of TB infection. It does not differentiate between different types of infection (current, ongoing, etc.). As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

The test kits must be stored at 2-30℃in the sealed pouch and under dry conditions.

1.  Dye L. Scheele S, V. Pathania, et al: 1999 Global Burden of Tuberculosis Estimated Incidence, Prevalence, and Morality by Country JAMA, 282:677-686.

2.  Dolin, P.J., Raviglione, M.C., Kochi, A. Global Tuberculosis Incidence and Mortality during 1990-2000. Bull. World Health Organization. 1994; 72:213-220.

3.  Murray C.J.L., Styblo, K., Rouillon, A,. Tuberculosis In Developing Countries:Burden, Intervention and Cost. Bull. Int. Tuberc. Lung Dis. 1990;65:6-24.

4. Schaaf, H. S. P. Botha, N. Beyers, R. P. Gie, H. A. et, al 1996. The 5-year outcome of multi drug resistant tuberculosis patient in the Cape Province of South Africa. Trop. Med. Int. Health 1:718-722.

5.  Merlin TL, Gibson DW, and DH Connor 1994. Tuberculosis. P400-404 in Rubein E and Farber JL (ed)- Pathology, 2nd edition . JB. Lippincott Company.

6. Daniel T. M. 1996. Immunodiagnosis of tuberculosis. P. 223-231. In W.N. Rom, and S. Garay (ed). Tuberculosis, Little, Brown & Co Boston, Mass,

7.  Wilkens, E.G.L. 1994. The serodiagnosis of tuberculosis .p. 367-379.In P.D.O. Davies 9 ED0 .Clinical tuberculosis. Chapman & Hall, Ltd, London, England.

8.  Krambovitis, E. Serodiagnosis of Tuberculosis in Perspective. 1987;Serodiagn. Immunoth. 1:7-19.

 

The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.