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Review
. 2025 Mar 24;3(3):CD015543.
doi: 10.1002/14651858.CD015543.pub2.

Truenat MTB assays for pulmonary tuberculosis and rifampicin resistance in adults and adolescents

Leeberk Raja Inbaraj  1 , Jefferson Daniel  2 , Mukesh Kumar Sathya Narayanan  3 , Vignes Anand Srinivasalu  1 , Adhin Bhaskar  4 , Katie Scandrett  5 , Priya Rajendran  6 , Richard Kirubakaran  7 , Hemant D Shewade  8 , Muniyandi Malaisamy  9 , Chandrasekaran Padmapriyadarsini  10 , Yemisi Takwoingi  5
Affiliations
Review

Truenat MTB assays for pulmonary tuberculosis and rifampicin resistance in adults and adolescents

Leeberk Raja Inbaraj et al. Cochrane Database Syst Rev. .

Abstract

Background: Accurate and rapid diagnosis is crucial for ending the tuberculosis epidemic. Truenat assays are World Health Organization (WHO)-recommended rapid molecular diagnostic tests that detect Mycobacterium tuberculosis complex and rifampicin resistance.

Objectives: Primary objective To assess the diagnostic accuracy of Truenat assays (MTB, MTB Plus, and MTB-RIF Dx) for detecting pulmonary tuberculosis and rifampicin resistance in adults and adolescents with presumptive pulmonary tuberculosis. Secondary objectives To compare the diagnostic accuracy of Truenat assays and Xpert MTB/RIF Ultra for detecting pulmonary tuberculosis and rifampicin resistance and to investigate potential sources of heterogeneity (e.g. HIV status and smear status).

Search methods: We searched MEDLINE, Embase, Science Citation Index and Biosis previews, Global Index Medicus, SCOPUS, WHO ICTRP, and ClinicalTrials.gov for published articles and trials in progress on 16and 17 October 2023. We searched ProQuest Dissertations & Theses A&I for dissertations. We contacted tuberculosis experts for ongoing and unpublished studies. A WHO public call for data was made between 30 November 2023 and 15 February 2024.

Selection criteria: We included cross-sectional and cohort studies that evaluated Truenat assays in sputum samples from adolescents and adults (aged 10 years and older). The microbiological reference standard for identifying pulmonary tuberculosis is culture. The reference standard for rifampicin resistance is a culture-based drug susceptibility test. Two review authors independently screened titles and abstracts, and assessed the full texts of potentially eligible articles. A third review author resolved any disagreements.

Data collection and analysis: We tailored and applied the QUADAS-2 and QUADAS-C tools to assess the risk of bias and applicability. Two review authors independently extracted data for each included study, and a third review author resolved any disagreements. We performed meta-analyses to estimate summary sensitivities and specificities using a bivariate model. We assessed the certainty of evidence using the GRADEpro GDT tool.

Main results: Of nine eligible articles, one contributed two distinct participant cohorts, which we considered as separate studies. Thus, we included 10 studies; three assessed Xpert Ultra. Most studies were set in low- and middle-income countries with a high tuberculosis burden. Six studies (4081 participants, 1379 with tuberculosis) assessed Truenat MTB, and four studies (3073 participants, 750 with tuberculosis) assessed Truenat MTB Plus. Two studies (966 participants, 111 with rifampicin resistance) assessed Truenat MTB-RIF Dx. Overall, the risk of bias in the included studies was low. Three of the 10 studies were judged to have high applicability concern in the patient selection domain. Detection of pulmonary tuberculosis The summary sensitivity of Truenat MTB was 87.6% (95% confidence interval (CI) 81.6 to 91.8; high-certainty evidence), and the summary specificity was 86.1% (95% CI 70.1 to 94.3; moderate-certainty evidence). For Truenat MTB Plus, the summary sensitivity was 90.6% (95% CI 83.7 to 94.8; high-certainty evidence), and the summary specificity was 95.7% (95% CI 94.7 to 96.5; high-certainty evidence). Based on the three comparative studies, the summary sensitivity of Truenat MTB was lower (81.0%, 95% CI 72.8 to 87.2) than that of Xpert Ultra (93.7%, 95% CI 90.4 to 95.9), while the summary specificity of Truenat MTB (97.0%, 95% CI 91.9 to 98.9) was marginally higher than Xpert Ultra (95.3%, 95% CI 90.9 to 97.7). Detection of rifampicin resistance The sensitivities from the two studies were 53% and 85% (moderate-certainty evidence) and specificities were both 97% (high-certainty evidence).

Authors' conclusions: Truenat MTB Plus had higher sensitivity and specificity than Truenat MTB. The high false-positive rate for Truenat MTB is a concern. The sensitivity of Xpert Ultra was significantly higher than that of Truenat MTB, while specificity was slightly lower. Evidence on the accuracy of Truenat MTB-RIF Dx was limited.

Trial registration: ClinicalTrials.gov NCT03712709 NCT02252198 NCT03303963 NCT04043390 NCT04568954 NCT05405296.

PubMed Disclaimer

Conflict of interest statement

Author team

LRI: none. Is employed at ICMR*.

JD: none.

MKSN: none. Is employed at ICMR*.

VAS: none. Is employed at ICMR*.

AB: none. Is employed at ICMR*.

KS: none.

PR: none. Is employed at ICMR*.

RK: none. He is on the editorial board of the Cochrane Statistical Methods group.

HDS: none. Is employed at ICMR*.

MM: none. Is employed at ICMR*.

CP: none. Is employed at ICMR*.

YT: none. She is a co‐convenor of the Cochrane Screening and Diagnostic Tests Methods Group and an editor of the Cochrane Infectious Diseases Group. She was not involved in the editorial process or decision‐making for this review.

*ICMR – this organization has published opinions in medical journals relevant to the interventions in the work and has declared its opinion on this topic.

Editors involved in editorial processing

CIDG Editor: Dr Karen Steingart reviewed data on Truenat and prepared GRADE tables for a WHO Guideline Development Meeting in December 2019 at the request of the WHO Global Tuberculosis Programme and received payment for this work. She has authored several Cochrane reviews on a similar technology: Cepheid's Xpert MTB/RIF and Xpert MTB/RIF Ultra.

DTA Editor: Dr Mariska Leeflang has no known conflicts of interest.

Figures

1
1
Clinical pathway Abbreviations: CXR+: chest X‐ray abnormal findings present; CXR‐: normal chest X‐ray; DSTB: drug‐sensitive tuberculosis; DRTB: drug‐resistant tuberculosis; FL‐LPA: first‐line line probe assay; RR: rifampicin resistance; INH: isoniazid; LC‐DST: liquid culture drug susceptibility testing; MDRTB: multiple‐drug‐resistant tuberculosis; MTB: Mycobacterium tuberculosis; mWRD: molecular WHO‐recommended rapid diagnostics; RIF: rifampicin; SL‐LPA: second‐line line probe assay. Adapted from WHO 2024.
2
2
Study flow diagram. #One study with two cohorts (Gomathi 2020a; Gomathi 2020b).
3
3
Risk of bias and applicability concerns summary: review authors' judgements about each domain for each included study.
4
4
Forest plot of Truenat MTB for pulmonary tuberculosis (including subgroups). The studies are sorted on the plot by sensitivity. FN: false negative; FP: false positive; TB: tuberculosis; TN: true negative; TP: true positive.
5
5
Summary ROC plot of Truenat MTB for pulmonary tuberculosis. The hollow circles/ovals are study points indicating the estimates of sensitivity and specificity. The width and height of each study point is proportional to the sample size for cases and non‐cases, respectively. The solid black circle is the summary point (summary estimates of sensitivity and specificity). The dotted region around the summary point is the 95% confidence region, illustrating the uncertainty around the summary point.
6
6
Forest plot of Truenat MTB for pulmonary tuberculosis. FN: false negative; FP: false positive; TB: tuberculosis; TN: true negative; TP: true positive.
7
7
Forest plot of Truenat MTB Plus for pulmonary tuberculosis (including subgroups). The studies are sorted on the plot by sensitivity. FN: false negative; FP: false positive; TB: tuberculosis; TN: true negative; TP: true positive.
8
8
Forest plot of Truenat MTB‐RIF Dx and Xpert Ultra for detection of rifampicin resistance. FN: false negative; FP: false positive; TN: true negative; TP: true positive.
1
1. Test
Truenat MTB for pulmonary tuberculosis
2
2. Test
Truenat MTB for pulmonary tuberculosis in peripheral laboratories
3
3. Test
HIV‐positive, Truenat MTB for pulmonary tuberculosis
4
4. Test
HIV‐negative, Truenat MTB for pulmonary tuberculosis
5
5. Test
Smear‐positive, Truenat MTB for pulmonary tuberculosis
6
6. Test
Smear negative, Truenat MTB for pulmonary tuberculosis
7
7. Test
History of tuberculosis, Truenat MTB for pulmonary tuberculosis
8
8. Test
No history of tuberculosis, Truenat MTB for pulmonary tuberculosis
9
9. Test
Truenat MTB for pulmonary tuberculosis in central laboratories
10
10. Test
Xpert MTB/RIF Ultra for pulmonary tuberculosis
11
11. Test
Truenat MTB‐RIF Dx for rifampicin resistance
12
12. Test
Truenat MTB‐RIF Dx for rifampicin resistance in central lab
13
13. Test
Truenat MTB‐RIF Dx for rifampicin resistance in peripheral laboratories
14
14. Test
Truenat MTB Plus for pulmonary tuberculosis – all data
15
15. Test
Truenat MTB Plus for pulmonary tuberculosis
16
16. Test
Truenat MTB Plus for pulmonary tuberculosis in peripheral laboratories
17
17. Test
HIV‐positive, Truenat MTB Plus for pulmonary tuberculosis
18
18. Test
HIV‐negative, Truenat MTB Plus for pulmonary tuberculosis
19
19. Test
Smear‐positive, Truenat MTB plus for pulmonary tuberculosis
20
20. Test
Smear‐negative, Truenat MTB Plus for pulmonary tuberculosis
21
21. Test
History of tuberculosis, Truenat MTB Plus for pulmonary tuberculosis
22
22. Test
No history of tuberculosis, Truenat MTB plus for pulmonary tuberculosis
23
23. Test
Truenat MTB Plus for pulmonary tuberculosis in central laboratories
24
24. Test
Truenat MTB for pulmonary tuberculosis (comparative)
25
25. Test
Truenat MTB Plus for tuberculosis (Peru)
26
26. Test
Truenat MTB Plus, bronchoalveolar fluid
27
27. Test
Smear‐positive, Truenat MTB‐RIF Dx for rifampicin resistance
28
28. Test
Smear‐negative, Truenat MTB‐RIF Dx for rifampicin resistance
29
29. Test
Truenat MTB‐RIF Dx for rifampicin resistance (Peru)
30
30. Test
Xpert Ultra for rifampicin resistance (Peru)
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD015543

References

References to studies included in this review

Gomathi 2020a {published and unpublished data}
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Meena 2023 {published data only}
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Ngangue 2022 {published data only}
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Akhtar 2022 {published data only}
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Georghiou 2021 {published data only}
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Sharma 2022 {published data only}
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Sharma 2023 {published data only}
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Sharma 2024a {published data only}
    1. Sharma K, Sharma M, Sharma A, Dhillon MS. Diagnosing osteoarticular tuberculosis and detecting rifampicin resistance: a comparative analysis of Truenat MTB Plus vs GeneXpert Ultra. Tuberculosis (Edinburgh, Scotland) 2024;145:102483. [DOI: 10.1016/j.tube.2024.102483] [PMID: ] - DOI - PubMed
Sharma 2024b {published data only}
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Singh 2023 {published data only}
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Valsan 2022 {published data only}
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Vijayalakshmi 2019 {published data only}
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References to ongoing studies

NCT02252198 {unpublished data only}
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NCT03303963 {unpublished data only}
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NCT04043390 {unpublished data only}
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NCT04568954 {unpublished data only}
    1. NCT04568954. TB-CAPT CORE Truenat trial [Molbio Truenat TB platform combined with the Truenat TB assays for detection of tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis at primary-level diagnostic centres in Tanzania and Mozambique: a pragmatic, cluster-randomized controlled trial]. clinicaltrials.gov/show/NCT04568954 (first received 29 September 2020). [CLINICALTRIALS.GOV: NCT04568954]
NCT05405296 {unpublished data only}
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References to other published versions of this review

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