Evaluation of truenat assays for the diagnosis of pulmonary and extrapulmonary tuberculosis: a systematic review and meta-analysis

Background Tuberculosis (TB) remains a significant global health concern, necessitating accurate and timely diagnostic methods. This study aimed to conduct a systematic review and meta-analysis to assess the diagnostic accuracy of Truenat assays for both pulmonary TB (PTB) and extrapulmonary TB (EPTB). Method PubMed, Scopus, and Web of Science were systematically searched for studies comparing Truenat assays to Mycobacterium tuberculosis confirmation methods. Results Comparing Truenat MTB assay with the Lowenstein-Jensen (LJ) culture, the pooled sensitivity and specificity were 86% (95% CI: 79-91%) and 86% (95% CI: 82-90%), respectively. For Mycobacterial Growth Indicator Tube (MGIT) culture comparison, pooled sensitivity was 88% (95% CI: 82-92%) with a specificity of 79% (95% CI: 57-92%). Compared to smear microscopy, Truenat assays displayed pooled sensitivity and specificity of 92% (95% CI: 78-98%) and 86% (95% CI: 64-95%). In comparison to Xpert MTB/RIF, Truenat assays exhibited a pooled sensitivity of 92% (95% CI: 80-97%) and a pooled specificity of 92% (95% CI: 56-99%) for PTB detection, and a pooled sensitivity of 94% (95% CI: 81-98%) and a specificity of 77% (95% CI: 32-96%) for the diagnosis of EPTB. Conclusion This study underscores the potential of Truenat assays as valuable tools for diagnosing both PTB and EPTB. Prospero id CRD42024526686.