INTENDED USE

Tuberculosis-LAM antigen (TB-LAM) Test Kit is a rapid and convenient immunochromatographic assay for the qualitative detection of lipoarabinomannan (LAM) antigen of Mycobacteria in human urine as an aid in diagnosis of active tuberculosis infection in HIV infectious individuals with clinical symptoms of tuberculosis.
This assay provides only a preliminary result. Negative results should be confirmed by culture or PCR methods; they do not preclude Tuberculosis infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

SUMMARY

Tuberculosis (TB) is caused by Mycobacterium tuberculosis. The bacteria usually attack the lungs, but it can attack any part of the body such as the kidney, spine, and brain. Not everyone infected with TB bacteria becomes sick. As a result, two TB-related conditions exist: latent TB infection (LTBI) and TB disease.
Approximately one third of the world population is infected with M. tuberculosis and 10 million new cases occur per year. Lipoarabinomannan (LAM) is abundant and significant surface antigen of this bacterium. it can be found in urine of HIV patients with active TB disease.

PRINCIPLE

TB-LAM Antigen test is an antigen-capture immunochromatographic assay, detecting presence of TB Lipoarabinomannan antigen in urine specimen. This assay utilizes the chemical extraction of viral antigens followed by solid-phase immunoassay technology for the detection of extracted TB Monoclonal antibodies specifically against TB-LAM antigen are conjugated with colloidal gold and deposited on the conjugate pad, and immobilized on the Test Zone on the nitrocellulose membrane. When a sample is added, the gold-antibody conjugate is rehydrated and the TB-LAM antigen, if any in the sample, will interact with the gold conjugated antibodies. The antigen-antibody-gold complex will migrate towards the test window until the Test Zone where they will be captured by immobilized antibodies, forming a visible pink line (Test band) indicative of positive results. If TB-LAM antigen are absent in the sample, no pink line will appear in the Test Zone (T).
To serve as an internal process control, a control band was designed to indicate that the test is performed properly. By utilizing the different antigen/antibody reaction, this control line should always be seen after test is completed. Absence of a pink control line in the control region is an indication of an invalid result.