This diagnostic kit is an in vitro nucleic acid amplification test for the detection of mycobacterium tuberculosis (TB) DNA in human sputum. It is intended for use as an aid in diagnosing an TB infection.
The diagnostic kit uses a nucleic acid lysis buffer to allow rapid lysis and release of TB-DNA from a sputum specimen. By applying real-time fluorescence quantitative PCR technology, this test utilizes a pair of specific primers which are designed to target at a conserved sequence of TB-DNA, a specific fluorescence probe, accompanied with PCR mix, to achieve fast detection of TB-DNA through fluorescent signal changes.
The PCR detection system uses UNG enzyme + dUTP contamination-proof system, which can fully degrade possible unwanted side-products, to avoid a false positive result.