Molecular Dx Significance 7/10

Lancet Microbe Review Maps the Expanding Toolkit for Isoniazid-Resistant TB Diagnostics

A scoping review of 238 studies catalogues the molecular diagnostics landscape for isoniazid-resistant tuberculosis, identifying 27 NAATs, 8 line probe assays, 5 DNA microarrays, and multiple NGS platforms developed since 2000. Most met WHO performance targets but remain too complex or costly for low-resource settings. The review highlights the critical gap between diagnostic capability and field-level accessibility for the most common form of drug-resistant TB.

The original study

Molecular diagnostic tests for isoniazid-resistant tuberculosis: a scoping review.

Authors
Nguyen TM, MacLean EL, Zhang X, Georghiou SB, Xia H, Beardsley J, et al.
Journal
The Lancet. Microbe
PMID
41871590
Read the original study →

Original abstract

The paucity of diagnostic tests for isoniazid-resistant tuberculosis is concerning, given its status as the most common form of drug-resistant tuberculosis and a gateway to multidrug-resistant diseases. Molecular drug-susceptibility testing has improved access to timely diagnosis of rifampicin-resistant tuberculosis, but testing for isoniazid-resistant tuberculosis still remains rare. In this Review, we assessed the characteristics of molecular drug-susceptibility testing for detection of isoniazid-resistant tuberculosis, referencing the WHO target product profiles. 9243 citations were screened to select 238 studies published between 2000 and 2024. The diagnostics options have expanded rapidly since 2020, with 27 nucleic acid amplification tests, eight line probe assays, five DNA microarrays, two targeted next-generation sequencing platforms, and two whole-genome sequencing platforms. Most of the evaluated molecular drug-susceptibility tests met diagnostic performance targets but were often complex and costly. Although a few low-complexity nucleic acid amplification tests met key target product profile criteria, additional field validation and greater efforts are needed to ensure optimal feasibility and affordability for low-resource settings.