2013, Issue 1 | Steingart KR, Sohn H, Schiller I, Kloda LA, Boehme CC, Pai M, Dendukuri N
This review assesses the diagnostic accuracy of the Xpert® MTB/RIF assay for detecting pulmonary tuberculosis (TB) and rifampicin resistance in adults. The Xpert assay is a rapid, automated test that can detect both TB and rifampicin resistance within two hours, with minimal hands-on technical time, but is more expensive than conventional sputum microscopy. The review includes 18 studies, with the majority performed in low- and middle-income countries. When used as an initial test replacing smear microscopy, Xpert achieved a pooled sensitivity of 88% and specificity of 98%. As an add-on test following a negative smear microscopy result, it yielded a pooled sensitivity of 67% and specificity of 98%. For rifampicin resistance detection, Xpert achieved a pooled sensitivity of 94% and specificity of 98%. The review concludes that Xpert is sensitive and specific for TB detection and rifampicin resistance detection, making it valuable for initial and add-on testing in patients suspected of having TB, multidrug-resistant TB, or HIV-associated TB. However, results should be interpreted carefully, considering the risk of multidrug-resistant TB and the expected prevalence in the setting. The review also highlights the need for further studies in routine programmatic and peripheral health care settings to build the evidence base for Xpert's diagnostic accuracy and clinical impact.This review assesses the diagnostic accuracy of the Xpert® MTB/RIF assay for detecting pulmonary tuberculosis (TB) and rifampicin resistance in adults. The Xpert assay is a rapid, automated test that can detect both TB and rifampicin resistance within two hours, with minimal hands-on technical time, but is more expensive than conventional sputum microscopy. The review includes 18 studies, with the majority performed in low- and middle-income countries. When used as an initial test replacing smear microscopy, Xpert achieved a pooled sensitivity of 88% and specificity of 98%. As an add-on test following a negative smear microscopy result, it yielded a pooled sensitivity of 67% and specificity of 98%. For rifampicin resistance detection, Xpert achieved a pooled sensitivity of 94% and specificity of 98%. The review concludes that Xpert is sensitive and specific for TB detection and rifampicin resistance detection, making it valuable for initial and add-on testing in patients suspected of having TB, multidrug-resistant TB, or HIV-associated TB. However, results should be interpreted carefully, considering the risk of multidrug-resistant TB and the expected prevalence in the setting. The review also highlights the need for further studies in routine programmatic and peripheral health care settings to build the evidence base for Xpert's diagnostic accuracy and clinical impact.