REF:

C2120 (Cassette)

INTENDED USE:

Tuberculosis Antigen Test is an immunoassay that uses the double-antibody sandwich method for qualitative detection of TB lipoarabinomannan (LAM) antigen from human urine specimen. It’s used as an aid in the diagnosis of TB infection. This device is performed manually.

SUMMARY:

Tuberculosis (TB) is caused by Mycobacterium tuberculosis. It mainly affects the human lungs but can also affect any other organ including bone, brain and spine. Approximately one-third of the world’s population is infected with Mycobacterium tuberculosis. Lipoarabinomannan (LAM) is a mycobacterial cell wall component excreted in the urine. Detection of LAM has been evaluated as a diagnostic tool. Early infection causes no symptoms as the body’s immune system protects spread, and in many cases, it remains inactive - this stage is referred to as “Latent TB”. Latent TB can develop into an Active TB. Studies have shown that LAM antigen can be found in urine during active TB disease. Early diagnosis and treatment are necessary to control the spread of the infection. The main clinical detection methods are TB skin test (Mantoux tuberculin skin test or PPD Test) and TB blood test (Interferon-gamma release assays or IGRAs). Tuberculosis Antigen Test can obtain result quickly and are simple to use, requiring no instrumentation to obtain results.