Abstract
OBJECTIVE: The objective of the study was to determine the diagnostic performance of the GenoQuick MTB test on heated sputum against the conventional Lowenstein-Jensen Mycobacterium tuberculosis culture as the reference method for tuberculosis diagnosis. INTRODUCTION: Fast, reliable, and easy-to-use tests for tuberculosis diagnosis are essential to achieving the Sustainable Development Goal of diagnosing and treating 90% of tuberculosis patients by 2030. We evaluated the diagnostic performance of the GenoQuick MTB, a polymerase chain reaction-lateral flow test, in Uganda, a resource-constrained, high tuberculosis- and HIV-burden setting. METHODS: Fresh sputum samples from presumptive tuberculosis patients at Mulago Hospital were tested for M. tuberculosis using smear microscopy, GenoQuick MTB test, and Lowenstein-Jensen culture. For the GenoQuick MTB test, mycobacterial DNA was extracted by heating sputum at 95°C for 30 min while DNA amplification and detection were done following the manufacturer's protocol (Hain Lifescience, Nehren, Germany). Sensitivity, specificity, and kappa agreements were calculated against Lowenstein-Jensen M. tuberculosis culture as a reference test using STATA V12. RESULTS: Of the 86 tested samples, 30.2% had culture-confirmed pulmonary tuberculosis. Overall, sensitivity was higher for GenoQuick MTB (81%, 95% confidence interval: 60%-93%) than for smear microscopy (69%, 95% confidence interval: 48%-86%). Among people living with HIV, sensitivity was identical for GenoQuick MTB and smear tests (75%, 95% confidence interval: 42%-95%). Contrastingly, smear had a higher overall specificity (98%, 95% confidence interval: 91%-100%) than for GenoQuick MTB (92%, 95% confidence interval: 81%-97%). A similar trend of specificity was observed among the people living with HIV for smear microscopy (100%, 95% CI: 87%-100%) and for GenoQuick MTB (96%, 95% confidence interval: 81%-100%). CONCLUSION: The GenoQuick MTB test could be a potential tuberculosis diagnostic test given its higher sensitivity. Evaluation of this test in larger studies is recommended.