Mycobacterium Tuberculosis Nucleic Acid and Rifampicin(RIF)，Isoniazid Resistance(INH)

Short Description:

This product 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 (81bp, rifampicin resistance determining region) of the rpoB gene that causes Mycobacterium tuberculosis rifampicin resistance.

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Product Detail

Product Tags

Product name

HWTS-RT147 Mycobacterium Tuberculosis Nucleic Acid and Rifampicin(RIF), Isoniazid Resistance (INH) Detection Kit (Melting Curve)

Epidemiology

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 ethambutol, 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.

Channel

Target Name			Reporter	Quencher
Reaction Buffer A	Reaction Buffer B	Reaction Buffer C	Reporter	Quencher
rpoB 507-514	rpoB 513-520	IS6110	FAM	None
rpoB 520-527	rpoB 527-533	/	CY5	None
/	/	Internal control	HEX(VIC)	None

Reaction Buffer D	Reporter	Quencher
InhA promoter region -15C>T, -8T>A, -8T>C	FAM	None
KatG 315 codon 315G>A、315G>C	CY5	None
AhpC promoter region -12C>T, -6G>A	ROX	None

Technical Parameters

Storage	≤-18℃
Shelf-life	12 months
Specimen Type	sputum
CV	≤5.0%
LoD	The LoD of mycobacterium tuberculosis national reference is 50 bacteria/mL. The LoD of rifampicin-resistant wild type national reference is 2×10³ bacteria/mL, and the LoD of mutant type is 2×10³ bacteria/mL. The LoD of wild-type isoniazid resistant bacteria is 2x10³ bacteria/mL, and The LoD of mutant bacteria is 2x10³ bacteria/mL.
Specificity	The cross test results showed that there was no cross reaction in the detection of human genome, other non tuberculosis mycobacteria and pneumonia pathogens with this kit; There was no cross reaction detected at mutation sites of other drug resistant genes in wild-type Mycobacterium tuberculosis.
Applicable Instruments	SLAN-96P Real-Time PCR Systems (Hongshi Medical Technology Co., Ltd.), BioRad CFX96 Real-Time PCR System, Hangzhou Bioer technology QuantGene 9600 Real-Time PCR System, QuantStudio^®5 Real-Time PCR System.