CorDx

(TB) Tuberculosis Test Serum/Plasma (Strip)

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

    Accessories:
Instruction for use, pipette,buffer
    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 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. Use the pipette to withdraw specimen and dispense 1 drop onto the sample pad.

4. Hold the buffer bottle vertically and dispense 1 drop to the sample pad. A separate test strip must be for each  specimen or control.

5. Wait for colored lines to appear. Read between 10-20 minutes. Do not interpret result after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15 – 30°C. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

 

INTERPRETATION OF RESULTS

POSITIVE:

Two colored lines appear in the result area, one in the test region and another one in the control region. The color intensity of the test line may be weaker or stronger than that of the control line.

NEGATIVE:

Only one colored line appears in test region of the result area.

INVALID:

No line appears in the control region 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.