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.
Footnotes
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Conflict of interest: Dr. Penn-Nicholson reports grants from Bill & Melinda Gates Foundation, during the conduct of the study; and Dr. Penn-Nicholson works 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 organization's external Scientific Advisory Council. FIND does not attribute any financial value to such access.
Conflict of interest: Dr. Gomathi reports grants from INDIAN COUNCIL OF MEDICAL RESEARCH - INDIA TB RESEARCH CONSORTIUM, during the conduct of the study; .
Conflict of interest: Dr. Ugarte-Gil has nothing to disclose.
Conflict of interest: Abyot Meaza has nothing to disclose.
Conflict of interest: Dr. Lavu has nothing to disclose.
Conflict of interest: Dr. Patel reports grants from From Indian Council of Medical Research through National Institute for Research in Tuberculosis Chennai, during the conduct of the study; .
Conflict of interest: Dr. Choudhury reports grants from INDIAN COUNCIL OF MEDICAL RESEARCH -India TB Research Consortium through NIRT Chennai, during the conduct of the study; .
Conflict of interest: Dr. Rodrigues has nothing to disclose.
Conflict of interest: Dr. Chadha reports and Dr. Chadha works 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 organization's external Scientific Advisory Council. FIND does not attribute any financial value to such access.
Conflict of interest: Dr. KAZI has nothing to disclose.
Conflict of interest: Dr. Macé reports and 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 organization's external Scientific Advisory Council. FIND does not attribute any financial value to such access.
Conflict of interest: Dr. Nabeta works 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 organization's external Scientific Advisory Council. FIND does not attribute any financial value to such access.
Conflict of interest: Dr. BOEHME reports grants, non-financial support and other from Multiple, outside the submitted work; .
Conflict of interest: Dr. Gangakhedkar has nothing to disclose.
Conflict of interest: Dr. Sarin reports grants from Bill & Melinda Gates Foundation, during the conduct of the study; and Dr. Sarin works 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 organization's external Scientific Advisory Council. FIND does not attribute any financial value to such access.
Conflict of interest: Dr. Tesfaye has nothing to disclose.
Conflict of interest: Dr. Gotuzzo has nothing to disclose.
Conflict of interest: Dr. du Cros reports grants from FIND, grants from Australian Department of Foreign Affairs and Trade during the conduct of the study; other from TB Alliance, outside the submitted work; and Dr du Cros is a member of the steering committee for the MSF Sponsored TB PRACTECAL Clinical Trial for novel regimens for MDR-TB treatment.
Conflict of interest: Dr. Tripathy reports grants from ICMR-India TB Research Consortium (ICMR-ITRC), during the conduct of the study; .
Conflict of interest: Dr. Ruhwald reports and 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 organization's external Scientific Advisory Council. FIND does not attribute any financial value to such access.
Conflict of interest: Dr. Singh has nothing to disclose.
Conflict of interest: Dr. Denkinger reports grants from Bill & Melinda Gates Foundation, during the conduct of the study; and Dr. Denkinger 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 organization's external Scientific Advisory Council. FIND does not attribute any financial value to such access. Since leaving FIND, Dr. Denkinger continues to hold a collaborative agreement with FIND.
Conflict of interest: Dr. Schumacher reports and Dr. 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 organization's external Scientific Advisory Council. FIND does not attribute any financial value to such access.
Conflict of interest: Dr. Dasho has nothing to disclose.
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