INTENDED USE

Tuberculosis-MPT64 (TB-MPT64) antigen Test Kit is a rapid and convenient immunochromatographic assay for the qualitative detection of TB MPT64 antigen of Mycobacteria in solid cultures or liquid cultures as a rapidly identifying Mycobacterium tuberculosis complex (MTC) and distinguishing between MTC and non-tuberculous mycobacteria (NTM) in AFB-positive cultures.
This assay provides only a preliminary result. Negative results should be confirmed by other 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. The differentiation between MTC and NTM is critical for TB control as well as for clinical practice, as the management and treatment of patients with TB differs from that of patients infected with other mycobacteria. Rapid confirmatory molecular tests are available for the identification of MTC from culture. However, these methods are comparatively expensive and generally require technical expertise and sophisticated equipment.

PRINCIPLE

TB MPT64 antigen Test is an antigen-capture immunochromatographic assay, detecting presence of TB MPT64 antigen in solid/liquid cultures. This assay is based on the detection of the MPT64 antigen which has been found in MTC culture media, but not for NTM. TB MPT64 Monoclonal antibodies specifically against MPT64 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 MPT64 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 MPT64 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.