Dataset Information

A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays.

ABSTRACT:

Background

Bringing reliable and accurate tuberculosis (TB) diagnosis closer to patients is a key priority for global TB control. Molbio Diagnostics have developed the Truenat point-of-care molecular assays for detection of TB and rifampicin (RIF) resistance.

Methods

We conducted a prospective multicentre diagnostic accuracy study at 19 primary healthcare centres and seven reference laboratories in Peru, India, Ethiopia and Papua New Guinea to estimate the diagnostic accuracy of the point-of-care Truenat MTB, MTB Plus and MTB-RIF Dx assays for pulmonary TB using culture and phenotypic drug susceptibility testing as the reference standard, compared with Xpert MTB/RIF or Ultra.

Results

Of 1807 enrolled participants with TB signs/symptoms, 24% were culture-positive for Mycobacterium tuberculosis, of which 15% were RIF-resistant. In microscopy centres, the pooled sensitivity of Truenat MTB and Truenat MTB Plus was 73% (95% CI 67-78%) and 80% (95% CI 75-84%), respectively. Among smear-negative specimens, sensitivities were 36% (95% CI 27-47%) and 47% (95% CI 37-58%), respectively. Sensitivity of Truenat MTB-RIF was 84% (95% CI 62-95%). Truenat assays showed high specificity. Head-to-head comparison in the central reference laboratories suggested that the Truenat assays have similar performance to Xpert MTB/RIF.

Conclusion

We found the performance of Molbio's Truenat MTB, MTB Plus and MTB-RIF Dx assays to be comparable to that of the Xpert MTB/RIF assay. Performing the Truenat tests in primary healthcare centres with very limited infrastructure was feasible. These data supported the development of a World Health Organization policy recommendation of the Molbio assays.

SUBMITTER: Penn-Nicholson A

PROVIDER: S-EPMC8607906 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Publications

A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays.

Penn-Nicholson Adam A Gomathi Sivaramakrishnan N SN Ugarte-Gil Cesar C Meaza Abyot A Lavu Evelyn E Patel Pranav P Choudhury Bandana B Rodrigues Camilla C Chadha Sarabjit S Kazi Mubin M Macé Aurélien A Nabeta Pamela P Boehme Catharina C Gangakhedkar Raman R RR Sarin Sanjay S Tesfaye Ephrem E Gotuzzo Eduardo E du Cros Philipp P Tripathy Srikanth S Ruhwald Morten M Singh Manjula M Denkinger Claudia M CM Schumacher Samuel G SG

The European respiratory journal 20211001 5

<h4>Background</h4>Bringing reliable and accurate tuberculosis (TB) diagnosis closer to patients is a key priority for global TB control. Molbio Diagnostics have developed the Truenat point-of-care molecular assays for detection of TB and rifampicin (RIF) resistance.<h4>Methods</h4>We conducted a prospective multicentre diagnostic accuracy study at 19 primary healthcare centres and seven reference laboratories in Peru, India, Ethiopia and Papua New Guinea to estimate the diagnostic accuracy of t ...[more]

PMID: 34049948

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Dataset Information

A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays.

Background

Methods

Results

Conclusion

Publications

A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays.

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