Abstract

The performance of the Xpert© MTB/RIF and MTBDRplus assays for the detection of rifampicin resistant Mycobacterium tuberculosis was compared to culture-based drug susceptibility testing in 30 specimens with rifampicin-resistant and rifampicin-indeterminate Xpert MTB/RIF results collected between March 2012 and March 2014. Xpert MTB/RIF and MTBDRplus were 100% sensitive and 100% concordant for rifampicin resistance detection, but 3 of 13 samples (23%) positive for rifampicin resistance on Xpert MTB/RIF and MTBDRplus were negative for rifampicin resistance on mycobacteria growth indicator tube drug susceptibility testing. Specificity was 72% for Xpert MTB/RIF and 80% for MTBDRplus. Positive predictive value for Xpert MTB/RIF for multidrug resistant tuberculosis was 47.8% for new patients and 77.8% for previously treated patients; negative predictive value was 100% for both new and previously treated patients. The discordant rifampicin resistance test results indicate a need to fully characterise circulating rifampicin resistant Mycobacterium tuberculosis strains in Zambia and to inform the development of guidelines for decision-making in relation to diagnosis of drug-resistant tuberculosis.

Highlights

  • Management and control of multidrug resistant (MDR) tuberculosis, tuberculosis that is resistant to both isoniazid and rifampicin, relies on timely and correct diagnosis

  • We report comparative observations made in a pilot study on the performance of Xpert MTB/RIF, MTBDRplus and Mycobacteria Growth Indicator Tube (MGIT) drug susceptibility testing methods for detection of rifampicin resistance in Lusaka, Zambia, at the Zambart Central Laboratory (ZCL)

  • Of the nine patients initially indeterminate for rifampicin resistance, five (56%) tested negative for rifampicin resistance and four (44%) tested negative for M. tuberculosis on repeat Xpert MTB/RIF testing (Table 1)

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Summary

Introduction

Management and control of multidrug resistant (MDR) tuberculosis, tuberculosis that is resistant to both isoniazid and rifampicin, relies on timely and correct diagnosis. The combination of Xpert MTB/RIF and MTBDRplus test results would be a powerful tool to achieve prompt confirmation of diagnosis of MDR tuberculosis. These genotypic methods, do not detect resistance conferred by mutations outside of the targeted gene region.[3,4,5]. We report comparative observations made in a pilot study on the performance of Xpert MTB/RIF, MTBDRplus and Mycobacteria Growth Indicator Tube (MGIT) drug susceptibility testing methods for detection of rifampicin resistance in Lusaka, Zambia, at the Zambart Central Laboratory (ZCL)

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