CorDx

(TB) Tuberculosis Test Whole Blood (Strip)

The TB Test Device is a chromatographic immunoassay (CIA) for direct qualitative
detection of tuberculosis antibody in human whole blood, serum or plasma.

    Accessories:
Instruction for use, pipette,buffer,sterile lancet
    Principle of Test:
Immunochromatographic assay
    Production Performance:
Specificity: 94.3%

INTENDED USE: The TB Test Device is a chromatographic immunoassay (CIA) for direct qualitative
detection of tuberculosis antibody in human whole blood, serum or plasma.

TEST PROCEDURE

1. Bring the pouched test strip to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test strip from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Hold the dropper vertically and transfer 1 drop of WB/Serum/Plasma to the sample pad of the test strip. Then hold the buffer bottle vertically and add 1 drop and start the timer.

4. Wait for the red line to appear. Read the result between 10-20minutes. Do not interpret the result after 20 minutes.

 

INTERPRETATION OF RESULTS

POSITIVE:

Two red lines are visible in the result area. The intensity of the test line may be weaker or darker than that of the control line. This still means a positive result.

NEGATIVE:

The control line appears in the result area, but the test line is not visible.

INVALID:

If the control line does not appear in the result area, the test results are INVALID regardless of the presence or absence of the line in the test region.

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new strip. If problem persists, please contact your local distributor.