TY - JOUR
T1 - Diagnostic accuracy study of the multiplex Truenat MTB Ultima/COVID-19 assay for simultaneous detection of Tuberculosis and SARS-CoV2 (COVID-19)
AU - COMBO study team
AU - Tootla, Hafsah
AU - Székely, Rita
AU - Sserubiri, James
AU - Zemanay, Widaad
AU - Patidar, Mala
AU - Joloba, Moses
AU - Ugarte-Gil, Cesar
AU - Ruhwald, Morten
AU - Purohit, Manju
AU - Cox, Helen
AU - Zamudio, Carlos
AU - Ssengooba, Willy
AU - Penn-Nicholson, Adam
AU - Leukes, Vinzeigh
AU - Singh, Sunita
AU - Chada, Sarabjit
AU - Kholi, Mikashmi
AU - Velen, Kavindhran
AU - Otieno, Michael
AU - Gaichiri, Mary
AU - Ogwal, Alex
AU - de Vos, Margaretha
AU - Tootla, Hafsah Deepa
AU - van Heerden, Judith
AU - Nyakutira, Nyasha
AU - Omar-Davies, Nashreen
AU - Taliep, Arshad
AU - Ssengooba, Willy
AU - Joloba, Moses
AU - Semugenze, Derrick
AU - Nakiyemba, Oliver
AU - Nakivubu, Ruth
AU - Kanthali, Mala
AU - Chauhan, Praveen
AU - Jain, Girish
AU - Soni, Shailendra
AU - Naik, D. P.
AU - Arya, Yogendra
AU - Uikey, Santosh
AU - Suryavanshi, Vinod
AU - Caceres, Tatiana
AU - del Carmen Caycho, María
N1 - Publisher Copyright:
© 2026 Tootla et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2026/6
Y1 - 2026/6
N2 - The COVID-19 pandemic led to significantly disrupted tuberculosis case detection and management. Additionally, overlapping symptoms, radiological findings and risk factors make differentiating tuberculosis and COVID-19 disease difficult. We conducted a prospective multicentre diagnostic accuracy study to determine sensitivity, specificity and operational characteristics of the Truenat MTB Ultima/COVID-19 assay, using a combined sputum plus nasopharyngeal swab specimen, in a single multiplex molecular assay. Participants were consenting adults with presumptive tuberculosis enrolled via convenience sampling from Uganda, Peru, South Africa, and India between August 2022 and December 2023. A microbiological reference standard of sputum GeneXpert MTB/RIF Ultra and culture was used for tuberculosis, whereas national RT-PCR was used for COVID-19. Wilson’s score method was used to determine the sensitivity and specificity. Of 1,928 participants enrolled, median age was 38 years (IQR 28–50), 359/1928 (18.6%) previously had TB, and 287/1928 (14.9%) were HIV-positive. Overall prevalence of tuberculosis was 24.8% [95% CI 22.9-26.8%]. Prevalence of COVID-19 was 3.8% [3.1-4.8%] overall, and 4.7% [3.1-7.0%] in those with confirmed tuberculosis. Overall sensitivity of Truenat MTB Ultima/ COVID-19 for tuberculosis was 79.8% [95% CI 76.0-83.2%]. When comparing paired samples, Truenat MTB Ultima/COVID-19 had a 9.5% [6.5-13.1%] decreased sensitivity against sputum TB culture, compared to GeneXpert Ultra; (82.8% [78.9-86.1%] vs 92.4% [89.4-94.5%]). Overall specificity of Truenat MTB Ultima/COVID-19 for tuberculosis was 98.9% [98.2-99.3%]. For COVID-19 detection, sensitivity of Truenat MTB Ultima/COVID-19 was 64.4% [52.9-74.4%], with specificity of 99.2% [98.7-99.5%]. Although optimal diagnostic performance was not demonstrated, the potential and need for rapid development of tests that integrate tuberculosis diagnosis with detection of other relevant respiratory infections is highlighted. The study was registered on ClinicalTrials.gov (NCT05405296).
AB - The COVID-19 pandemic led to significantly disrupted tuberculosis case detection and management. Additionally, overlapping symptoms, radiological findings and risk factors make differentiating tuberculosis and COVID-19 disease difficult. We conducted a prospective multicentre diagnostic accuracy study to determine sensitivity, specificity and operational characteristics of the Truenat MTB Ultima/COVID-19 assay, using a combined sputum plus nasopharyngeal swab specimen, in a single multiplex molecular assay. Participants were consenting adults with presumptive tuberculosis enrolled via convenience sampling from Uganda, Peru, South Africa, and India between August 2022 and December 2023. A microbiological reference standard of sputum GeneXpert MTB/RIF Ultra and culture was used for tuberculosis, whereas national RT-PCR was used for COVID-19. Wilson’s score method was used to determine the sensitivity and specificity. Of 1,928 participants enrolled, median age was 38 years (IQR 28–50), 359/1928 (18.6%) previously had TB, and 287/1928 (14.9%) were HIV-positive. Overall prevalence of tuberculosis was 24.8% [95% CI 22.9-26.8%]. Prevalence of COVID-19 was 3.8% [3.1-4.8%] overall, and 4.7% [3.1-7.0%] in those with confirmed tuberculosis. Overall sensitivity of Truenat MTB Ultima/ COVID-19 for tuberculosis was 79.8% [95% CI 76.0-83.2%]. When comparing paired samples, Truenat MTB Ultima/COVID-19 had a 9.5% [6.5-13.1%] decreased sensitivity against sputum TB culture, compared to GeneXpert Ultra; (82.8% [78.9-86.1%] vs 92.4% [89.4-94.5%]). Overall specificity of Truenat MTB Ultima/COVID-19 for tuberculosis was 98.9% [98.2-99.3%]. For COVID-19 detection, sensitivity of Truenat MTB Ultima/COVID-19 was 64.4% [52.9-74.4%], with specificity of 99.2% [98.7-99.5%]. Although optimal diagnostic performance was not demonstrated, the potential and need for rapid development of tests that integrate tuberculosis diagnosis with detection of other relevant respiratory infections is highlighted. The study was registered on ClinicalTrials.gov (NCT05405296).
UR - https://www.scopus.com/pages/publications/105042489536
U2 - 10.1371/journal.pgph.0005859
DO - 10.1371/journal.pgph.0005859
M3 - Artículo
AN - SCOPUS:105042489536
SN - 2767-3375
VL - 6
JO - PLOS Global Public Health
JF - PLOS Global Public Health
IS - 6 June
M1 - e0005859
ER -