ArticleAnnals of laboratory medicine2026
Effect of Variability on Interferon-Gamma Release Assay Performance: A Quantitative Analysis.
Article in Annals of laboratory medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- A detailed analysis of borderline results in the QuantiFERON-TB Gold-Plus assay incorporating longitudinal follow-up: intermediate-burden setting.Microbiology spectrum · 2026Article
- Longitudinal dynamics and treatment-associated determinants of interferon-gamma responses in tuberculosis: a 10-year retrospective QuantiFERON-TB Gold study.Frontiers in cellular and infection microbiology · 2026Article
Corrections and comments
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Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Interferon-gamma release assays (IGRAs) are widely used to identify latent tuberculosis infection (LTBI); however, inherent test variability affects their diagnostic interpretation. We evaluated false-positive and false-negative rates, as well as conversion and reversion rates across CVs of 20%, 40%, 60%, 80%, and 100%, using statistical modeling. At a diagnostic cutoff of 0.35 IU/mL, false-negative rates increased from 1.61% to 33.41% with increasing CVs, whereas false-positive rates ranged from 0.00% to 15.87% within the 0.20-0.70 IU/mL borderline range. Expanding the borderline to 0.20-1.00 IU/mL reduced false-positive rates to a maximum of 3.16%, without affecting false-negative rates. Within the 0.20-0.70 IU/mL borderline zone, correct reversion and false conversion rates at 0.20 and 0.35 IU/mL ranged from 0.01% to 25.00% and 0.00% to 24.20%, respectively. At 0.35, 0.70, and 1.00 IU/mL, correct conversion and false reversion rates ranged from 0.05% to 24.20% and 0.00% to 25.00%, respectively. These results highlight the importance of adopting borderline zones in IGRA interpretation to reduce misclassification, although variability from manufacturing, pre-analytical processing, and analytical procedures remains a significant challenge. Reducing such variability through improved production consistency, standardized sample handling, and automated analysis platforms is essential to enhance the diagnostic reliability of IGRAs for LTBI.
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