Tuberculosis (TB) Test


National High-tech Enterprise


Tuberculosis (TB) is an infectious disease usually caused by Mycobacterium tuberculosis (MTB) bacteria. Tuberculosis generally affects the lungs, but can also affect other parts of the body.Most infections show no symptoms, in which case it is known as latent tuberculosis.About 10% of latent infections progress to active disease which, if left untreated, kills about half of those affected.The classic symptoms of active TB are a chronic cough with blood-containing mucus, fever, night sweats, and weight loss.It was historically called consumption due to the weight loss.Infection of other organs can cause a wide range of symptoms.


Tuberculosis is spread from one person to the next through the air when people who have active TB in their lungs cough, spit, speak, or sneeze.People with latent TB do not spread the disease.Active infection occurs more often in people with HIV/AIDS and in those who smoke.Diagnosis of active TB is based on chest X-rays, as well as microscopic examination and culture of body fluids. Diagnosis of latent TB relies on the tuberculin skin test (TST) or blood tests


The Tuberculosis Rapid Test Device (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of anti-TB antibodies (Isotypes IgG, IgM and IgA) in whole blood, serum or plasma specimens.



Test device



Package insert



【TEST PROCEDURE FOR Tuberculosis (TB) Test


Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1.Remove the test device from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch.

2.For Serum or Plasma Specimens:

 Hold the dropper vertically, transfer 3 drops of serum or plasma (approximately 105 L) to the specimen well (S) of test device and then start the timer. See illustration below.

 For Whole Blood Specimens:

Hold the dropper vertically and transfer 1 drop of whole blood (approximately 35 L) to the specimen well (S) of test device, then add 2 drops of buffer (approximately 80 L) and start the timer. See illustration below.

3. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.






25 tests/box;

40 tests/box