[Product Name]

Mycobacterium Tuberculosis Nucleic Acid and Rifampicin Resistance Detection Kit (Melting Curve)

[Packaging Size]

50 tests/kit

[Intended Use]

This kit is suitable for the qualitative detection of Mycobacterium tuberculosis DNA in human sputum samples in vitro, as well as the homozygous mutation in the 507-533 amino acid codon region of the rpoB gene that causes Mycobacterium tuberculosis rifampicin resistance.

Mycobacterium tuberculosis，shortly as Tubercle bacillus, TB, is the pathogenic bacterium that causes tuberculosis. Currently, the commonly used first-line anti-tuberculosis drugs include isoniazid, rifampicin and hexambutol, etc. The second-line anti-tuberculosis drugs include fluoroquinolones, amikacin and kanamycin, etc. The new developed drugs are linezolid, bedaquiline and delamani, etc. However, due to the incorrect use of anti-tuberculosis drugs and the characteristics of the cell wall structure of mycobacterium tuberculosis, mycobacterium tuberculosis develops drug resistance to anti-tuberculosis drugs, which brings serious challenges to the prevention and treatment of tuberculosis.

Rifampicin has been widely used in the treatment of pulmonary tuberculosis patients since the late 1970s, and has a significant effect. It has been the first choice to shorten the chemotherapy of  pulmonary tuberculosis patients. Rifampicin resistance is mainly caused by the mutation of the rpoB gene. Although new anti-tuberculosis drugs are constantly coming out, and the clinical efficacy of pulmonary tuberculosis patients has also continued to improve, there is still a relative lack of anti-tuberculosis drugs, and the phenomenon of irrational drug use in clinical is relatively high. Obviously, the Mycobacterium tuberculosis in patients with pulmonary tuberculosis cannot be completely killed in a timely manner, which eventually leads to different degrees of drug resistance in the patient's body, prolongs the course of the disease, and increases the risk of death of the patient.

This kit is suitable for the auxiliary diagnosis of Mycobacterium tuberculosis infection and the detection of rifampicin resistance gene, which is helpful to understand the drug resistance of mycobacterium tuberculosis infected by patients, and to provide auxiliary means for clinical medication guidance. The test results are for clinical reference only, and the final diagnosis should be comprehensively considered in close combination with other clinical indicators.

[Main Components]

Note: Components of different batches cannot be interchanged.

[Storage Conditions and Shelf-life]

This kit should be stored under -18°C and protected from light, and the shelf life is 9 months (please use within the shelf life). After opening, the number of repeated freezing and thawing times is no more than 4 cycles, and it can be stored stably for 5 days when transported below -18°C and protected from light.

See the packaging label for the production date and expiration date.

[Applicable Instruments]

SLAN-96P Real-Time PCR Systems(Shanghai Hongshi Medical Technology Co., Ltd. ), LightCycler®480 Real-Time PCR system.