Title
A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays
Date Issued
01 November 2021
Access level
open access
Resource Type
journal article
Author(s)
Penn-Nicholson A.
Gomathi S.N.
Ugarte-Gil C.
Meaza A.
Lavu E.
Patel P.
Choudhury B.
Rodrigues C.
Chadha S.
Kazi M.
Macé A.
Nabeta P.
Boehme C.
Gangakhedkar R.R.
Sarin S.
Tesfaye E.
du Cros P.
Tripathy S.
Ruhwald M.
Singh M.
Denkinger C.M.
Schumacher S.G.
Publisher(s)
European Respiratory Society
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.
Volume
58
Issue
5
Language
English
OCDE Knowledge area
Medicina tropical
Epidemiología
Scopus EID
2-s2.0-85114988130
PubMed ID
Source
European Respiratory Journal
ISSN of the container
09031936
Sponsor(s)
Conflict of interest: A. Penn-Nicholson reports grants from Bill and Melinda Gates Foundation, during the conduct of the study; reports working for FIND. FIND conducts multiple clinical research projects to evaluate multiple new diagnostic tests against published target product profiles that have been defined through consensus processes. These include studies of diagnostic products developed by private sector companies who provide access to know-how, equipment/reagents, and may contribute through unrestricted donations according to FIND policies and in line with guidance from the organisation’s external scientific advisory council. FIND does not attribute any financial value to such access. S.N. Gomathi reports grants from Indian Council of Medical Research - India TB Research Consortium, during the conduct of the study. C. Ugarte-Gil has nothing to disclose. A. Meaza has nothing to disclose. E. Lavu has nothing to disclose. P. Patel reports grants from the Indian Council of Medical Research through the National Institute for Research in Tuberculosis Chennai, during the conduct of the study. B. Choudhury reports grants from Indian Council of Medical Research – India TB Research Consortium through the National Institute for Research in Tuberculosis Chennai, during the conduct of the study. C. Rodrigues has nothing to disclose. S. Chadha reports working for FIND. FIND conducts multiple clinical research projects to evaluate multiple new diagnostic tests against published target product profiles that have been defined through consensus processes. These include studies of diagnostic products developed by private sector companies who provide access to know-how, equipment/reagents, and may contribute through unrestricted donations according to FIND policies and in line with guidance from the organisation’s external scientific advisory council. FIND does not attribute any financial value to such access. M. Kazi has nothing to disclose. A. Macé reports working for FIND. FIND conducts multiple clinical research projects to evaluate multiple new diagnostic tests against published target product profiles that have been defined through consensus processes. These include studies of diagnostic products developed by private sector companies who provide access to know-how, equipment/reagents, and may contribute through unrestricted donations according to FIND policies and in line with guidance from the organisation’s external scientific advisory council. FIND does not attribute any financial value to such access. P. Nabeta reports working for FIND. FIND conducts multiple clinical research projects to evaluate multiple new diagnostic tests against published target product profiles that have been defined through consensus processes. These include studies of diagnostic products developed by private sector companies who provide access to know-how, equipment/reagents, and may contribute through unrestricted donations according to FIND policies and in line with guidance from the organisation’s external scientific advisory council. FIND does not attribute any financial value to such access. C. Boehme reports working for FIND. FIND conducts multiple clinical research projects to evaluate multiple new diagnostic tests against published target product profiles that have been defined through consensus processes. These include studies of diagnostic products developed by private sector companies who provide access to know-how, equipment/reagents, and may contribute through unrestricted donations according to FIND policies and in line with guidance from the organisation’s external scientific advisory council. FIND does not attribute any financial value to such access. R.R. Gangakhedkar has nothing to disclose. S. Sarin reports grants from Bill and Melinda Gates Foundation, during the conduct of the study; and reports working for FIND. FIND conducts multiple clinical research projects to evaluate multiple new diagnostic tests against published target product profiles that have been defined through consensus processes. These include studies of diagnostic products developed by private sector companies who provide access to know-how, equipment/reagents, and may contribute through unrestricted donations according to FIND policies and in line with guidance from the organisation’s external scientific advisory council. FIND does not attribute any financial value to such access. E. Tesfaye has nothing to disclose. E. Gotuzzo has nothing to disclose. P. du Cros reports grants from FIND and the Australian Dept of Foreign Affairs and Trade during the conduct of the study; other (consultancy) from TB Alliance, outside the submitted work; and is a member of the steering committee for the MSF Sponsored TB PRACTECAL Clinical Trial for novel regimens for MDR-TB treatment. S. Tripathy reports grants from ICMR-India TB Research Consortium (ICMR-ITRC), during the conduct of the study. M. Ruhwald reports working for FIND. FIND conducts multiple clinical research projects to evaluate multiple new diagnostic tests against published target product profiles that have been defined through consensus processes. These include studies of diagnostic products developed by private sector companies who provide access to know-how, equipment/reagents, and may contribute through unrestricted donations according to FIND policies and in line with guidance from the organisation’s external scientific advisory council. FIND does not attribute any financial value to such access. M. Singh has nothing to disclose. C.M. Denkinger reports grants from the Bill and Melinda Gates Foundation, during the conduct of the study; and reports working for FIND until April 2019. FIND conducts multiple clinical research projects to evaluate multiple new diagnostic tests against published target product profiles that have been defined through consensus processes. These include studies of diagnostic products developed by private sector companies who provide access to know-how, equipment/reagents, and may contribute through unrestricted donations according to FIND policies and in line with guidance from the organisation’s external scientific advisory council. FIND does not attribute any financial value to such access. Since leaving FIND, C.M. Denkinger continues to hold a collaborative agreement with FIND. S.G. Schumacher reports working for FIND. FIND conducts multiple clinical research projects to evaluate multiple new diagnostic tests against published target product profiles that have been defined through consensus processes. These include studies of diagnostic products developed by private sector companies who provide access to know-how, equipment/reagents, and may contribute through unrestricted donations according to FIND policies and in line with guidance from the organisation’s external scientific advisory council. FIND does not attribute any financial value to such access.
The authors would like to thank the study participants and their families for generously volunteering to participate in this study, as well as the study sites for their time and effort in conducting the study, and assisting with the analysis of the operational data. The authors also thank Molbio Diagnostics Pvt. Ltd (Bangalore, India) for their technical expertise towards the study. Medical writing support was provided by Talya Underwood of Anthos Communications Ltd (Manchester, UK), funded by the Foundation for Innovative New Diagnostics (FIND) (Geneva, Switzerland). This work was supported by the Bill and Melinda Gates Foundation (OPP1208706), India TB Research Consortium, Indian Council of Medical Research, Australian Dept of Foreign Affairs and Trade via the PNGAus Partnership, and the German KfW Development Bank. The funders of the study had no role in study design, data collection, data analysis, data interpretation or writing of the manuscript. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. Funding information for this article has been deposited with the Crossref Funder Registry.
Support statement: This work was supported by the Bill and Melinda Gates Foundation (OPP1208706), India TB Research Consortium, Indian Council of Medical Research, Australian Dept of Foreign Affairs and Trade via the PNGAus Partnership, and the German KfW Development Bank. The funders of the study had no role in study design, data collection, data analysis, data interpretation or writing of the manuscript. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. Funding information for this article has been deposited with the Crossref Funder Registry.
Acknowledgements: The authors would like to thank the study participants and their families for generously volunteering to participate in this study, as well as the study sites for their time and effort in conducting the study, and assisting with the analysis of the operational data. The authors also thank Molbio Diagnostics Pvt. Ltd (Bangalore, India) for their technical expertise towards the study. Medical writing support was provided by Talya Underwood of Anthos Communications Ltd (Manchester, UK), funded by the Foundation for Innovative New Diagnostics (FIND) (Geneva, Switzerland).
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