Diagnostic Performance of New Commercial Interferon-Gamma Release Assays for Mycobacterium tuberculosis Infection: An Updated Systematic Review and Meta-analysis

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Abstract
Background: The World Health Organization (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. Methods: Databases (Medline, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and International Clinical Trials Registry Platform) 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 IGRAs and WHO-endorsed IGRAs. Results: From 3039 records screened, 39 reports (36 published) describing 8 new IGRAs met eligibility: STANDARD E TB-Feron, LIAISON XL Analyzer (chemiluminescence immunoassay [CLIA]), Ichroma IGRA-TB, STANDARD F TB-Feron, VIDAS TB-IGRA, ASACIR.TB, Wantai CLIA, and AdvanSureI3 TB-IGRA. STANDARD E TB-Feron had nonsignificantly lower sensitivity (−2.8% [95% confidence interval {CI}, −11.8% to 6.2%]) and specificity (−3.6% [95% CI, −10.0% to 2.7%]), with kappa of 0.802 (95% CI, .729–.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/QFT-GIT, with a pooled kappa of 0.846 (95% CI, .814–.878). Conclusions: Two of the 8 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 tuberculosis infection tests. Clinical Trials Registration. PROSPERO (CRD42024544404).
Funding Information
  • Global TB Programme

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