Diagnostic Accuracy of GeneXpert MTB/RIF Assay in Comparison to Conventional Drug Susceptibility Testing Method for the Diagnosis of Multidrug-Resistant Tuberculosis.

Igor Mokrousov,Narayan Dutt Pant,Rajendra Kc,Bhagwan Maharjan,Megha Raj Banjara,Sirita Kattel,Komal Raj Rijal,Bhawana Shrestha,Pratikshya Pandey

doi:10.1371/journal.pone.0169798

Igor Mokrousov, Narayan Dutt Pant + Show 7 more

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https://doi.org/10.1371/journal.pone.0169798

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Abstract

Xpert MTB/RIF assay is regarded as a great achievement of modern medicine for the rapid diagnosis of multidrug-resistant tuberculosis (MDR-TB). The main purpose of this study was to determine the performance of Xpert MTB/RIF assay compared to conventional drug susceptibility testing (DST) method for the diagnosis of MDR-TB. A comparative cross sectional study was carried out at German-Nepal Tuberculosis Project, Kathmandu, Nepal, from April 2014 to September 2014. A total of 88 culture positive clinical samples (83 pulmonary and 5 extra-pulmonary) received during the study period were analyzed for detection of multidrug-resistant tuberculosis by both GeneXpert MTB/RIF assay and conventional DST method. McNemar chi square test was used to compare the performance of Xpert with that of DST method. A p-value of less than 0.05 was considered as statistically significant. Of total 88 culture positive samples, one was reported as invalid while 2 were found to contain nontuberculous Mycobacteria (NTM). Among remaining 85 Mycobacterium tuberculosis culture positive samples, 69 were found to be MDR-TB positive by both methods. The overall sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GeneXpert MTB/RIF assay were found to be 98.6%, 100%, 100% and 93.8% respectively. Statistically, there was no significant difference between the diagnostic performance of Xpert and conventional DST method for detection of MDR-TB. GeneXpert MTB/RIF assay was found to be highly sensitive, specific and comparable to gold standard conventional DST method for the diagnosis of MDR-TB.

Highlights

Tuberculosis (TB) presents as a serious public health problem, globally with an estimated 10.4 million new TB cases in 2015 [1]
We aimed to evaluate the diagnostic accuracy of Xpert Mycobacterium tuberculosis (MTB)/RIF assay in comparison to conventional drug susceptibility testing (DST) for diagnosis of multidrug-resistant tuberculosis (MDR-TB) in our setting
1/85 and 2/85 cases reported as RIF sensitive by GeneXpert assay were found to be resistant to RIF and isoniazid (INH) respectively by conventional DST

Summary

Introduction

Tuberculosis (TB) presents as a serious public health problem, globally with an estimated 10.4 million new TB cases in 2015 [1]. It is a leading cause of deaths from infectious diseases (with worldwide estimated 1.8 million deaths in 2015), large numbers of deaths mainly occurring in low and middle income countries [1]. There is an increasing trend of prevalence of MDR-TB in Nepal. According to the recent drug resistance surveillance in Nepal, the prevalence of MDR-TB was 2.6% in case of newly diagnosed tuberculosis cases and17.6% among previously treated cases [2]

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