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

Ghaith Altawallbeh, Deanna Gabrielson, Jennifer M Peters, Anthony A. Killeen

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1287-1292
Number of pages6
JournalThe journal of applied laboratory medicine
Volume6
Issue number5
DOIs
StatePublished - Sep 1 2021

Bibliographical note

Publisher Copyright:
© American Association for Clinical Chemistry 2021. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Keywords

  • LIAISON XL
  • QuantiFERON-TB Gold Plus
  • evaluation
  • tuberculosis

PubMed: MeSH publication types

  • Journal Article
  • Research Support, Non-U.S. Gov't

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