Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults (Review)

Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults (Review)

2013, Issue 1 | Steingart KR, Sohn H, Schiller I, Kloda LA, Boehme CC, Pai M, Dendukuri N
The Cochrane review evaluates the diagnostic accuracy of the Xpert® MTB/RIF assay for detecting pulmonary tuberculosis (TB) and rifampicin resistance in adults. The review included 18 studies, most conducted in low- and middle-income countries. Xpert, a rapid, automated test, detects TB and rifampicin resistance within two hours with minimal technical requirements but is more expensive than conventional sputum microscopy. When used as an initial test replacing smear microscopy, Xpert had a pooled sensitivity of 88% (95% CrI 83%–92%) and specificity of 98% (95% CrI 97%–99%). As an add-on test following a negative smear result, Xpert had a pooled sensitivity of 67% (95% CrI 58%–74%) and specificity of 98% (95% CrI 97%–99%). In clinical subgroups, Xpert showed high accuracy for smear-positive TB (98% sensitivity) and lower accuracy for smear-negative TB (68% sensitivity). For rifampicin resistance detection, Xpert had a pooled sensitivity of 94% (95% CrI 87%–97%) and specificity of 98% (95% CrI 97%–99%). Xpert can distinguish TB from non-tuberculous mycobacteria (NTM) with high accuracy. In a hypothetical cohort of 1000 individuals suspected of rifampicin resistance, Xpert would wrongly identify 14 patients as resistant if the prevalence is 30%, but 20 patients if the prevalence is 2%. Xpert is recommended as an initial diagnostic test for TB and rifampicin resistance, especially in settings with limited resources. It may also be useful as an add-on test for smear-negative patients. Positive rifampicin resistance results should be interpreted carefully, considering the risk of multidrug-resistant TB (MDR-TB) in the patient and the prevalence in the setting. The review highlights that Xpert is sensitive and specific for TB and rifampicin resistance detection. It is particularly valuable in high TB burden countries where it can be used in peripheral health facilities. The results suggest that Xpert improves diagnostic accuracy and clinical outcomes, especially in resource-limited settings. The review also notes that Xpert's performance in reference laboratories may not fully reflect its use in routine settings, and ongoing use in high TB burden countries will contribute to understanding its diagnostic accuracy and impact in real-world scenarios.The Cochrane review evaluates the diagnostic accuracy of the Xpert® MTB/RIF assay for detecting pulmonary tuberculosis (TB) and rifampicin resistance in adults. The review included 18 studies, most conducted in low- and middle-income countries. Xpert, a rapid, automated test, detects TB and rifampicin resistance within two hours with minimal technical requirements but is more expensive than conventional sputum microscopy. When used as an initial test replacing smear microscopy, Xpert had a pooled sensitivity of 88% (95% CrI 83%–92%) and specificity of 98% (95% CrI 97%–99%). As an add-on test following a negative smear result, Xpert had a pooled sensitivity of 67% (95% CrI 58%–74%) and specificity of 98% (95% CrI 97%–99%). In clinical subgroups, Xpert showed high accuracy for smear-positive TB (98% sensitivity) and lower accuracy for smear-negative TB (68% sensitivity). For rifampicin resistance detection, Xpert had a pooled sensitivity of 94% (95% CrI 87%–97%) and specificity of 98% (95% CrI 97%–99%). Xpert can distinguish TB from non-tuberculous mycobacteria (NTM) with high accuracy. In a hypothetical cohort of 1000 individuals suspected of rifampicin resistance, Xpert would wrongly identify 14 patients as resistant if the prevalence is 30%, but 20 patients if the prevalence is 2%. Xpert is recommended as an initial diagnostic test for TB and rifampicin resistance, especially in settings with limited resources. It may also be useful as an add-on test for smear-negative patients. Positive rifampicin resistance results should be interpreted carefully, considering the risk of multidrug-resistant TB (MDR-TB) in the patient and the prevalence in the setting. The review highlights that Xpert is sensitive and specific for TB and rifampicin resistance detection. It is particularly valuable in high TB burden countries where it can be used in peripheral health facilities. The results suggest that Xpert improves diagnostic accuracy and clinical outcomes, especially in resource-limited settings. The review also notes that Xpert's performance in reference laboratories may not fully reflect its use in routine settings, and ongoing use in high TB burden countries will contribute to understanding its diagnostic accuracy and impact in real-world scenarios.
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[slides and audio] Xpert%C2%AE Mtb%2FRif assay for pulmonary tuberculosis and rifampicin resistance in adults