One Step Anti-TB Test is a rapid direct binding test for the qualitative detection of antibodies to Mycobacterium tuberculosis(M.tuberculosis) antigen in human serum or plasma, as an aid in the clinical assessment of Mycobacterium tuberculosis viruses infection.
Principle of the Procedure:
One Step Anti-TB Test uses a double antigens “sandwich principle”1 for the detection of M.tuberculosis antibody in human serum/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.This one step test is very sensitive and only takes about 15 minutes.Test results are read visually without any instrument.
1. To begin testing; open the sealed pouch by tearing along the notch.. Remove the test form the pouch.
2. lay the cassette flat on a clean, dry, nonabsorbent surface ,draw about 30ul whole blood into the sample pad.
3. Then draw one drop of Sodium Chloride(about 20ul)into the sample well as well.
4. Wait for colored bands to appear. Read results within 15 minutes. Do not read results after 20 minutes
Negative: Only one pink band appears on test region of the Cassette. This indicates that there is no detectable anti-TP in the whole blood.
Positive: Two pink bands appear on test region of the Cassette. This indicates that the specimen contains
detectable amount of anti-TP.
Invalid: If without colored band appears on test region, this is an indication of a possible error in performing
the test. The test should be repeated using a new device.