Open AccessDiagnostic accuracy of Truenat Tuberculosis and Rifampicin-Resistance assays in Addis Ababa, Ethiopia
Author(s) -
Abyot Meaza,
Ephrem Tesfaye,
Zemedu Mohamed,
Betselot Zerihun,
Getachew Seid,
Kirubel Eshetu,
Miskir Amare,
Waganeh Sinshaw,
Biniyam Dagne,
Hilina Mollalign,
Getu Diriba,
Melak Getu,
Bazezew Yenew,
Mekonnen Tadesse,
Dinka Fikadu,
Yeshiwork Abebaw,
Shewki Moga,
Abebaw Kebede,
Habteyes Hailu Tola,
Ayinalem Alemu,
Muluwork Getahun,
Balako Gumi
Publication year - 2021
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0261084
Subject(s) - tuberculosis , medicine , rifampicin , sputum , mycobacterium tuberculosis , drug resistance , diagnostic accuracy , extensively drug resistant tuberculosis , tuberculosis diagnosis , liquid culture , virology , microbiology and biotechnology , pathology , biology , botany
Background Rapid and sensitive Tuberculosis (TB) diagnosis closer to patients is a key global TB control priority. Truenat assays (MTB, MTB Plus, and MTB-RIF Dx) are new TB molecular diagnostic tools for the detection of TB and Rifampicin (RIF)-resistance from sputum samples. The diagnostic accuracy of the assays is needed prior to implementation in clinical use in Ethiopia. This study aimed to determine the sensitivity and specificity of Truenat assays; and aimed to compare the assays to the Xpert MTB/RIF assay. Methods A prospective evaluation study was conducted among 200 presumptive TB patients in microscopy centers in Addis Ababa, Ethiopia from May 2019 to December 2020. Culture (Solid and Liquid methods) and phenotypic (liquid method) drug susceptibility testing (DST) were used as a reference standard. Results Of 200 adult participants, culture confirmed TB cases were 25 (12.5%), and only one isolate was resistant to RIF by phenotypic DST. The sensitivity of Truenat MTB was 88.0% [95% CI 70.1, 95.8], while 91.7 [95% CI 74.2, 97.7] for Truenat MTB Plus at the microscopy centers. The specificity of Truenat MTB was 97.2% [95% CI 93.1, 98.9], while for Truenat MTB Plus was 97.2% [95% CI 93.0, 99.0]. The sensitivity of Truenat MTB was 90.5% while for MTB Plus, 100% compared to the Xpert MTB/RIF assay. Conclusion Truenat assays were found to have high diagnostic accuracy. The assays have the potential to be used as a point of care (POC) TB diagnostic tests.