SynthesisClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026
Diagnostic Performance of New Commercial Interferon-Gamma Release Assays for Mycobacterium tuberculosis Infection: An Updated Systematic Review and Meta-analysis.
Synthesis in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe 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.
methodsDatabases (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.
resultsFrom 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).
conclusionsTwo 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).
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