CorDx

(TP) Anti-Syphilis Test Serum/Plasma(Cassette)

One Step Syphilis Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Treponema Pallidum (TP) to aid in the diagnosis of Syphilis.

    Accessories:
Instruction for use
    Principle of Test:
Immunochromatographic assay
    Product Performance:
Sensitivity: 99.20%

 

INTENDED USE: One Step Syphilis Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Treponema Pallidum (TP) to aid in the diagnosis of Syphilis.

 

TEST PROCEDURE

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

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

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. 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 red lines are visible in the result window. 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 window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, 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 device. If problem persists, please contact your local distributor.