A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays.

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 <

SUBMITTER: Penn-Nicholson A 

PROVIDER: S-EPMC8607906 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature