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ProductName:MTB Drug Resistant Mutation Detection

MTB Drug Resistant Mutation Detection

 

Molecular Diagnostics   

Fast & Accurate

 

Features:

Fast:  Results can be obtained in 8 hrs

High throughput:  The assay can detect 13 mutation site of 5 resistance related genes

Sensitivity: 1.0×104 copies/ml

Sanger sequencing as a gold standard: Accuracy>95%; Specificity>98%; Repeatability: >99%

Sample type: sputum, isolated strain

Application: The assay can apply on all size of laboratory with general instruments, such as PCR and hybridization equipment

 

Method and Process

This system contains gene chip technology which includes PCR and RDB

 

MTB Drug Resistance

Rifampicin, Isoniazid, Ethambutol and Streptomycin are frequently used anti-TB drugs, but taking these drugs after long period, or having non-standard treatment could lead to MTB gene mutation. The clinical manifestations are tuberculosis drug resistance. The coincidence rate is as blow:

 

Anti-TB drugs

Resistance gene

Drug Sensitivity Coincidence rate

Rifampicin

rpoB

95%

Isoniazid

katG

80-85%

inhA

80%

Streptomycin

rpL

80%

Ethambutol

embB

85%

 

Applicable population

Patients who use anti-TB drugs for long period

Patients who have non-standard treatment

Chronic tuberculosis patients (after multiple irregular treatment but still MTB positive)

Smear positive patients who have close contact with tuberculosis patients

Smear positive patients for retreatment (including those went through a retreatment failure).

Smear positive patients (first time treatment) who still have sputum smear positive after 3 months treatment.

 

Significance of the Drug Resistance Detection

1. Detection of MTB drug resistance mutants provide the basis for anti-TB drug selection for doctors, ensuring the efficacy and reducing the spread of drug resistant strains.

2. Significantly shorten the time of detection (traditional culture of drug sensitivity takes weeks), which favor tuberculosis treatment.

3. Apply gene chip technology for drug resistant mutants’ detection, avoid false negative in drug sensitivity culturing methods and have much more accurate and reliable results.

4. Study the MTB drug resistant distribution in general population; provide the reference for tuberculosis prevention and treatment.