What question did this study set out to answer?

To evaluate the real-world outcomes of implementing a fully automated chemiluminescence immunoassay for tuberculosis screening.

April 24, 2026Open Access

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Real-World Outcomes of Chemiluminescence Immunoassay Implementation for Mycobacterium tuberculosis Infection Screening

EWEli Wilber MSMarcos C SchechterEmory University PRPaulina A. RebolledoEmory University

Key Points

To evaluate the real-world outcomes of implementing a fully automated chemiluminescence immunoassay for tuberculosis screening.
Analyzed testing outcomes before and after CLIA assay implementation
Compared positive rates using fully automated versus semi-automated assays
Assessed the impact on clinical care based on test results
Observed a relative increase of 87.8% in borderline-positive IGRA results
95% confidence interval ranged from 31.1 to 170.0%
Modifications in clinical care ensued due to increased positive test rates

Abstract

Unstructured Abstract Fully automated CLIA-based interferon gamma release assays (IGRA) promise more efficient testing for tuberculosis infection but increase positive test rates compared to semi-automated assays. We report an increase in borderline-positive IGRA results (87.8% relative increase, 95% CI: 31.1–170.0%) which led to modifications in clinical care following CLIA assay implementation.

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Real-World Outcomes of Chemiluminescence Immunoassay Implementation for Mycobacterium tuberculosis Infection Screening

Key Points

Abstract

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