Abstract
Introduction
We compared the performance of a fluorescence lateral flow assay (ichroma™ IGRA-TB) with the QuantiFERON-TB Gold PLUS (QFT-PLUS) for the diagnosis of latent tuberculosis infection (LTBI) in patients with immune-mediated inflammatory diseases (IMID) prior to receiving biologics therapy.
Method
The comparability of the ichroma™ IGRA-TB assay with the QFT-PLUS assay for the diagnosis of LTBI was determined in prospectively enrolled patients with IMID prior to receiving biologics between August 2018 and October 2019. To determine the best cut-off value of the ichroma™ IGRA-TB, an ROC curve analysis was performed.
Results
Patients with IMID (n = 145) had inflammatory bowel disease (n = 83; 57.2%), rheumatoid arthritis (n = 44; 30.3%), or spondyloarthropathy (n = 18; 12.4%). The median age was 40.5 (interquartile range: 27.0–56.0), 72 (49.7%) were men, and 140 (96.6%) received BCG vaccination. With the manufacturer-recommended cut-off values, 11 (7.6%) and 20 (13.8%) patients showed positive results with the ichroma™ IGRA-TB and QFT-PLUS tests, respectively. The overall agreement between the two tests was 91.0% with a Cohen’s kappa value of 0.535 (95% confidence interval: 0.317–0.754). ROC curve analysis of the QFT-PLUS results showed that a cut-off value of > 0.21 IU/mL would improve the performance of the ichroma™ IGRA-TB. Using the new cut-off value, the concordance rate was improved to 93.1% with a Cohen’s kappa value of 0.668 (95% confidence interval: 0.478–0.858).
Conclusions
The ichroma™ IGRA-TB could be used as a point-of-care test for LTBI screening in IMID patients before starting biologics, especially in resource-limited settings.
Key Points • The ichroma™ IGRA-TB is an automated fluorescence lateral flow assay–based IGRA. • The test has advantages like short turn-around time, low-cost, and ease of use. • The ichroma™ IGRA-TB showed high agreement with the QuantiFERON-TB Gold In-Tube in patients with chronic immune-mediated inflammatory diseases before starting biologics. |
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This work was supported in part by the Korea Health Technology R&D Project (HI17C1000), through the Korea Health Industry Development Institute, from the Ministry of Health & Welfare, South Korea.
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This study was approved by the Institutional Review Board of Asan Medical Center (IRB No.: 2017-1303). All participants provided written informed consent.
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Lee, H.H., Choi, D.H., Kim, JR. et al. Evaluation of a lateral flow assay–based IFN-γ release assay as a point-of-care test for the diagnosis of latent tuberculosis infection. Clin Rheumatol 40, 3773–3781 (2021). https://doi.org/10.1007/s10067-021-05663-1
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DOI: https://doi.org/10.1007/s10067-021-05663-1