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. 2021 Dec 28;16(12):e0261084.
doi: 10.1371/journal.pone.0261084. eCollection 2021.

Diagnostic accuracy of Truenat Tuberculosis and Rifampicin-Resistance assays in Addis Ababa, Ethiopia

Abyot Meaza  1   2 , Ephrem Tesfaye  1 , Zemedu Mohamed  1 , Betselot Zerihun  1 , Getachew Seid  1 , Kirubel Eshetu  1 , Miskir Amare  1 , Waganeh Sinshaw  1 , Biniyam Dagne  1 , Hilina Mollalign  1 , Getu Diriba  1 , Melak Getu  1 , Bazezew Yenew  1 , Mengistu Tadesse  1 , Dinka Fikadu  1 , Yeshiwork Abebaw  1 , Shewki Moga  1 , Abebaw Kebede  1 , Habteyes Hailu Tola  1 , Ayinalem Alemu  1 , Muluwork Getahun  1 , Balako Gumi  2
Affiliations

Diagnostic accuracy of Truenat Tuberculosis and Rifampicin-Resistance assays in Addis Ababa, Ethiopia

Abyot Meaza et al. PLoS One. .

Abstract

Background: Rapid and sensitive Tuberculosis (TB) diagnosis closer to patients is a key global TB control priority. Truenat assays (MTB, MTB Plus, and MTB-RIF Dx) are new TB molecular diagnostic tools for the detection of TB and Rifampicin (RIF)-resistance from sputum samples. The diagnostic accuracy of the assays is needed prior to implementation in clinical use in Ethiopia. This study aimed to determine the sensitivity and specificity of Truenat assays; and aimed to compare the assays to the Xpert MTB/RIF assay.

Methods: A prospective evaluation study was conducted among 200 presumptive TB patients in microscopy centers in Addis Ababa, Ethiopia from May 2019 to December 2020. Culture (Solid and Liquid methods) and phenotypic (liquid method) drug susceptibility testing (DST) were used as a reference standard.

Results: Of 200 adult participants, culture confirmed TB cases were 25 (12.5%), and only one isolate was resistant to RIF by phenotypic DST. The sensitivity of Truenat MTB was 88.0% [95% CI 70.1, 95.8], while 91.7 [95% CI 74.2, 97.7] for Truenat MTB Plus at the microscopy centers. The specificity of Truenat MTB was 97.2% [95% CI 93.1, 98.9], while for Truenat MTB Plus was 97.2% [95% CI 93.0, 99.0]. The sensitivity of Truenat MTB was 90.5% while for MTB Plus, 100% compared to the Xpert MTB/RIF assay.

Conclusion: Truenat assays were found to have high diagnostic accuracy. The assays have the potential to be used as a point of care (POC) TB diagnostic tests.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Laboratory testing workflow at microscopy center and reference laboratory.
Fig 2
Fig 2
Diagnostic accuracy comparison of Truenat assays and Xpert MTB/RIF against Cultuer/DST for MTB detection (a) and MTB-RIF resistance detection (b).
See this image and copyright information in PMC

References

    1. World Health Organization. Global Tuberculosis Report. In: Annual Report. Geneva: WHO, 2020.
    1. Ethiopian Ministry of Health. Report of an independent mid-term review of the implementation of the Ethiopia TB and Leprosy Control Strategic Plan. January 2017.
    1. World Health Organization. Global tuberculosis report 2018. 2018. Geneva: World Health Organization. 2019.
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    1. Molbio Diagnostic Product Limited. Truenat™ MTB package insert 2020 [Available from: http://www.molbiodiagnostics.com/uploads/product_download/20190927.15214.... 2020. Accessed (December 21, 2020).

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