Evaluation of MTBDRplus 2.0 in the diagnosis of drug resistance of Mycobacterium tuberculosis
Objective To evaluate the sensitivity and specificity of the GenoType MTBDRplus V2.0(Mycobacterium tuberculosis and resistance gene detection assay kit using PCR-linear probe hybridization with enzyme chromogenic method,referred to as MTBDRplus 2.0)kit for detection of rifampin and isoniazid resistance,providing the basis for improving the detection of drug-resistant Mycobacterium tuberculosis.Methods From January to December 2022,positive strains of Mycobacterium tuberculosis isolated and cultured from designated tuberculosis treatment hospitals in 32 counties(cities,districts)of Yunnan Province were collected.Resistance in 880 strains of Mycobacterium tuberculosis was detected by MTBDRplus 2.0,and the minimum inhibitory concentration(MIC)method was used for the drug sensitivity test.Results Using the MIC method as the gold standard,the sensitivity,specificity,positive predictive value,and negative predictive value of MTBDRplus 2.0 in detecting isoniazid resistance were 67.69％,98.40％,77.19％,and 97.45％,respectively.The consistency of the linear probe method and MIC method in detecting isoniazid resistance was moderate,with a Kappa value of 0.701(P＜0.001);the sensitivity,specificity,positive predictive value,and negative predictive values of MTBDRplus 2.0 in detecting rifampicin resistance were 87.80％,99.40％,87.80％,and 99.40％,respectively.The consistency of rifampicin resistance detection between MTBDRplus 2.0 and MIC method was relatively good,with a Kappa value of 0.872(P＜0.001).Among the 13 strains showing resistance to isoniazid with MTBDRplus 2.0,but sensitivity according to the MIC method,11 strains(84.62％)had mutations in the inhA gene(C15T).Out of the 5 strains showing resistance to rifampicin with MTBDRplus 2.0,but sensitivity according to the MIC method,4 strains(80.00％)had other mutations in the rpoB gene.Conclusions MTBDRplus 2.0 shows high sensitivity and specificity in detecting rifampicin resistance,but slightly low sensitivity in detecting isoniazid resistance.The low sensitivity in detecting isoniazid resistance may be due to insufficient target coverage of the detection kit.inhA gene mutations are poorly correlated with isoniazid resistance,and other mutations in the rpoB gene are poorly correlated with rifampicin resistance.
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