Performance of an Advanced Interferon-Gamma Release Assay for Mycobacterium tuberculosis Detection.

BACKGROUND The LIAISON® QuantiFERON®-TB Gold Plus (QFT-Plus) assay, a fully automated chemiluminescence immunoassay (CLIA) system, has recently received FDA approval for the detection of interferon-γ (IFN-γ) on the LIAISON XL analyzer. Here, we evaluated the diagnostic performance of the LIAISON's CLIA method in comparison to the widely used ELISA method using the Qiagen QuantiFERON-TB Gold Plus Blood Collection Tubes. METHODS Heparinized blood samples from 329 participants were categorized into 3 cohorts, including 15 with confirmed tuberculosis (TB) (active TB cohort), 129 non-TB (low-risk cohort), and 185 potential TB (mixed risk cohort). Samples were analyzed with both assays and results were interpreted according to the manufacturers' criteria. RESULTS The LIAISON CLIA assay showed an overall agreement with the Qiagen ELISA assay in 13/14 (92.8%) samples among the active cohort, 93/95 (97.9%) among the low-risk cohort, with a Cohen's kappa value of 0.76 and 0.74, respectively. Test results for 185 mixed risk cohort participants showed 97.8% agreement between the LIAISON and the Qiagen, with 17 positive, 163 negative, and 1 indeterminate. Four samples were discrepant; 3 of these were negative on the ELISA but positive on the CLIA assay. CONCLUSION Overall, the results were comparable (>92% agreement) in our study cohorts. In addition, our mixed risk cohort results showed an excellent agreement of 0.88 (Cohen's kappa value) between the 2 assays. These findings suggest that the automated LIAISON QFT-Plus assay has a comparable diagnostic performance to the Qiagen assay and can be used for latent TB infection (LTBI) diagnosis.