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(TB) Tuberculosis Test Serum/Plasma (Cassette)

(TB) Tuberculosis Test Serum/Plasma (Cassette) Image

    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 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 to the sample well.
4. Hold the buffer bottle vertically and add 1-2 drops to the sample well./ If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 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°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 pink lines appear in the result window. This indicates that the specimen contains detectable amount of TB antibody.

NEGATIVE:
Only one pink line appears in test region of the result window. This indicates that there is no detectable TB antibody in the specimen.

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 device. If problem persists, please contact your local distributor.

(TB) Tuberculosis Test Serum/Plasma (Cassette)

(TB) Tuberculosis Test Serum/Plasma (Cassette) Image

    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 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 to the sample well.
4. Hold the buffer bottle vertically and add 1-2 drops to the sample well./ If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 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°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 pink lines appear in the result window. This indicates that the specimen contains detectable amount of TB antibody.

NEGATIVE:
Only one pink line appears in test region of the result window. This indicates that there is no detectable TB antibody in the specimen.

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 device. If problem persists, please contact your local distributor.