Universidad Peruana Cayetano Heredia

A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays

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dc.contributor.author Penn-Nicholson, Adam
dc.contributor.author Gomathi, Sivaramakrishnan N.
dc.contributor.author Ugarte Gil, Cesar Augusto
dc.contributor.author Meaza, Abyot
dc.contributor.author Lavu, Evelyn
dc.contributor.author Patel, Pranav
dc.contributor.author Choudhury, Bandana
dc.contributor.author Rodrigues, Camilla
dc.contributor.author Chadha, Sarabjit
dc.contributor.author Kazi, Mubin
dc.contributor.author Macé, Aurélien
dc.contributor.author Nabeta, Pamela
dc.contributor.author Boehme, Catharina
dc.contributor.author Gangakhedkar, Raman R.
dc.contributor.author Sarin, Sanjay
dc.contributor.author Tesfaye, Ephrem
dc.contributor.author Gotuzzo Herencia, José Eduardo
dc.contributor.author du Cros, Philipp
dc.contributor.author Tripathy, Srikanth
dc.contributor.author Ruhwald, Morten
dc.contributor.author Singh, Manjula
dc.contributor.author Denkinger, Claudia M.
dc.contributor.author Schumacher, Samuel G.
dc.date.accessioned 2021-06-08T15:46:12Z
dc.date.available 2021-06-08T15:46:12Z
dc.date.issued 2021
dc.identifier.uri https://hdl.handle.net/20.500.12866/9468
dc.description.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 health care 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 to 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 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 health care centres with very limited infrastructure was feasible. These data supported the development of a WHO policy recommendation of the Molbio assays en_US
dc.language.iso eng
dc.publisher European Respiratory Society
dc.relation.ispartofseries European Respiratory Journal
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject diagnostic accuracy en_US
dc.subject Truenat tuberculosis assays en_US
dc.subject tuberculosis en_US
dc.title A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1183/13993003.00526-2021
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.07
dc.relation.issn 1399-3003


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