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Review Article

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

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Received 15 Apr 2024, Accepted 05 Aug 2024, Accepted author version posted online: 08 Aug 2024
 
Accepted author version

ABSTRACT

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 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 the 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

Disclaimer

As a service to authors and researchers we are providing this version of an accepted manuscript (AM). Copyediting, typesetting, and review of the resulting proofs will be undertaken on this manuscript before final publication of the Version of Record (VoR). During production and pre-press, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal relate to these versions also.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Data availability statement

The data that support the findings of this study are available from the corresponding author, upon reasonable request.

Author contributions

S Mahmoudi made a significant contribution to the conception, study design, execution, data acquisition, and analysis and interpretation of the work. S Mahmoudi wrote the draft. S Mahmoudi and AS Moghaddasi critically reviewed the final manuscript. AS Moghaddasi made a significant contribution to data acquisition. S Mahmoudi and AS Moghaddasi agreed on the journal for submission and reviewed and approved all versions of the article submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage. S Mahmoudi and AS Moghaddasi agree to take responsibility and be accountable for the contents of the article and to share responsibility to resolve any questions raised about the accuracy or integrity of the published work.

Acknowledgements

The work of Shima Mahmoudi received partial support from the European Commission-European Research Executive Agency (REA) under grant agreement No. 101130873.

Additional information

Funding

This paper was funded by the Horizon Europe (HORIZON), as a research project under the “HORIZON-WIDERA-2022-TALENTS-04-01” program (Project Number: 101130873- DET-TB).

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