TB Tuberculosis Antibody Test Strip

The One Step TB Test Strip is a chromatographic immunoassay for the qualitative detection of antibodies to M. tuberculosis in human serum. This test is intended for professional use as an aid in the detection of antibodies against M. tuberculosis in human serum. Three specially selected TB recombinant proteins are used in test band as capture materials and gold conjugates. These enable the Rapid TB Test to identify antibodies to TB in human serum, with a high degree of accuracy.

Features

• High accuracy over 99.2%
• Relative Sensitivity 96.9%
• Relative Specificity 99.8%
• Read results in 15 minutes

Packaging

Box of 50T, Ctn of 5000T

INTRODUCTION

One Step Anti-Tuberculosis Test is a rapid direct binding test for the visual detection of anti- Tuberculosis antibodies in serum as an aid in the diagnosis of Tuberculosis infection. Test results are read visually without any instrument. It is based on the principle of double antigen sandwich immunoassay for determination of Tuberculosis antibodies in serum. Purified recombinant Tuberculosis antigens are employed to identify anti- Tuberculosis antibodies specifically. This one step test is very sensitive and only takes about 10 to 15 minutes.

SPECIMEN COLLECTION

For serum, collect blood into a container without anticoagulant.  Allow the blood to clot and separate the serum from the clot.                          Use the serum for testing.

If the specimen cannot be tested on the day of collection, store the serum specimen in a refrigerator or freezer. Bring the specimens to room temperature before testing. Do not freeze and thaw the specimen repeatedly.

TEST PROCEDURE

When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.Strip

1. Wait 10-15 minutes and read resu Do not read results after 15 minutes.
2. Immerse the strip into the container with the arrow end pointing towards the container. Do not immerse past the MAX (maximum) line.
3. Take the strip out after 8-10 seconds and lay the strip flat on a clean, dry, nonabsorbent surface (e.g., mouth of the serum container).

INTERPRETATION OF RESULTS

Negative: Only one pink band appears on test region of the Cassette. This indicates that there is no detectable anti- Tuberculosis in the serum.

Positive: Two pink bands appear on test region of the Cassette. This indicates that the specimen contains detectable amount of anti- Tuberculosis.

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.

PRECAUTION:

1. Must use fresh specimen and avoid repetitive freezing, the result will be invalid
2. Use it before expiry date.
3. The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator. 4、Old Serum can not be used. If the serum is thick, it can be used only after being separated.

LIMITATIONS

The test is for in-vitro diagnostic use only.