Diagnostic Performance of New Commercial IGRAs for Mycobacterium tuberculosis Infection: An updated Systematic Review and Meta-analysis.

Abstract

The WHO currently endorses several commercial Interferon Gamma Release Assays (IGRAs); policy updates are needed given the development of new tests. We conducted an updated systematic review and meta-analysis to compare sensitivity, specificity, and agreement of newly commercialized IGRAs with WHO-endorsed IGRAs. Databases (Medline, EMBASE, Web of Science, CENTRAL, and ICTRP) were searched for studies published from 1 February 2021 to 30 September 2024, then again up to 16 December 2025. We included cross-sectional, cohort, and case-control studies, and assessed risk of bias using QUADAS-2. The primary outcomes were pooled differences in sensitivity, specificity, and agreement between the new IGRA's and WHO-endorsed IGRA's. From 3039 records screened, 39 reports (36 published) describing eight new IGRAs met eligibility: STANDARD E TB-Feron, LIAISON XL Analyzer (CLIA), Ichroma IGRA-TB, STANDARD F TB-Feron, VIDAS TB-IGRA, ASACIR.TB, WANTAI CLIA, AdvanSureI3 TB-IGRA. STANDARD E TB-Feron had non-significantly lower sensitivity (-2.8%, 95% CI: -11.8% to 6.2%) and specificity (-3.6%, 95% CI: -10.0% to 2.7%), with kappa of 0.802 (95% CI: 0.729 to 0.874), compared to QFT-plus. For LIAISON XL Analyzer the specificity was 0.1% higher (95% CI: -6.2% to 6.4%), than QFT-Plus/GIT, with a pooled kappa of 0.846 (95% CI: 0.814 to 0.878). Two of the eight new tests reviewed showed promising accuracy and high agreement with WHO-endorsed IGRAs. The overall certainty of evidence remains low due to risk of bias and imprecision. High-quality, independent studies in diverse populations and settings are needed to inform future WHO recommendations for TB infection tests.