TY - JOUR
T1 - Performance of an Advanced Interferon-Gamma Release Assay for Mycobacterium tuberculosis Detection
AU - Altawallbeh, Ghaith
AU - Gabrielson, Deanna
AU - Peters, Jennifer M.
AU - Killeen, Anthony A.
N1 - Publisher Copyright:
© 2021 The authors.
PY - 2021/9/1
Y1 - 2021/9/1
N2 - Background: The LIAISONVR QuantiFERONVR -TB Gold Plus (QFT-Plus) assay, a fully automated chemiluminescence immunoassay (CLIA) system, has recently received FDA approval for the detection of interferon-c (IFN-c) 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.
AB - Background: The LIAISONVR QuantiFERONVR -TB Gold Plus (QFT-Plus) assay, a fully automated chemiluminescence immunoassay (CLIA) system, has recently received FDA approval for the detection of interferon-c (IFN-c) 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.
KW - LIAISON XL
KW - QuantiFERON-TB Gold Plus
KW - evaluation
KW - tuberculosis
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U2 - 10.1093/jalm/jfab012
DO - 10.1093/jalm/jfab012
M3 - Article
C2 - 33829248
AN - SCOPUS:85116958359
SN - 2576-9456
VL - 6
SP - 1287
EP - 1292
JO - The journal of applied laboratory medicine
JF - The journal of applied laboratory medicine
IS - 5
ER -