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Mycobacterium Tuberculosis Isoniazid Resistance Detection Kit(Fluorescence PCR)

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Category:Respiratory tract infection

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Mycobacterium Tuberculosis Isoniazid Resistance Detection Kit(Fluorescence PCR)

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Introduction

[Product Name]

Mycobacterium Tuberculosis Isoniazid Resistance Detection Kit(Fluorescence PCR)

 

[Packaging Size]

50 tests/kit

 

[Intended Use]

This kit is used to qualitatively detect the gene mutation of the 315th amino acid of the katG gene (K315G>C) and the gene mutation of the promoter region of the InhA gene (- 15 C>T).

Isoniazid, a key anti-tuberculosis drug introduced in 1952, is one of the most effective drugs for combined treatment of active tuberculosis and a single drug for latent tuberculosis. katG is the main gene encoding catalase-peroxidase and katG gene mutation can promote the synthesis of mycolic acid cell wall, making the bacteria resistant to isoniazid. katG expression is negatively correlated with changes in INH-MIC, and a 2-fold decrease in katG expression results in a slightly larger 2-fold increase in MIC. Another cause of isoniazid resistance in mycobacterium tuberculosis occurs when base insertion, deletion or mutation occurs in the InhA gene locus of mycobacterium tuberculosis. The fifth national TB epidemiological sampling survey report in 2010 in China shows that the total drug resistance rate of INH in China reached 28.6%, and it increases fast comparing to INH 17.6% of the fourth national result in 2000. The drug resistance situation is very serious.

This kit detects two common mutation sites of isoniazid resistance, which helps to understand the drug resistance of mycobacterium tuberculosis infected by patients and provides auxiliary means for clinical medication guidance. In specific clinical applications, clinicians need to make judgments based on the actual situation of the patient, and the test results of this kit cannot be used as the only basis for clinical diagnosis.

 

 

[Main Components]

S/N

Component(50 tests/kit)

Strength

Quantity

Component Description

1

INH Reaction Buffer 1

1mL/vial

1vial

Wild-type primers and fluorescent probes containing inhA and katG sites; PCR reaction buffer (including buffer, dNTP mixture, dUTP, DNA polymerase, uracil DNA glycosylase, etc.)

2

INH Reaction Buffer 2

1mL/vial

1vial

Primers and fluorescent probes containing inhA, katG site mutants and internal reference IS6110; PCR reaction buffer (including buffer, dNTP mixture, dUTP, DNA polymerase, uracil DNA glycosylase, etc.)

3

INH Positive Control

600μL/vial

1vial

inhA, katG site wild-type plasmid, mutant plasmid and internal reference IS6110 plasmid dilution

4

INH Blank Control

600μL/vial

1vial

DNase/RNase free H2O

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 12 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]

Applied Biosystems 7500 Real-Time PCR Systems, Applied Biosystems 7500 Fast Real-Time PCR Systems, QuantStudio®5 Real-Time PCR Systems, SLAN-96P Real-Time PCR Systems(Shanghai Hongshi Medical Technology Co., Ltd. ), LightCycler®480 Real-Time PCR system, LineGene 9600 Plus Real-Time PCR Detection SystemFQD-96ABioer technology), MA-6000 Real-Time Quantitative Thermal Cycler (Suzhou Molarray Co., Ltd.) , BioRad CFX96 Real-Time PCR System, BioRad CFX Opus 96 Real-Time PCR System.

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