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Evaluation of a lateral flow assay–based IFN-γ release assay as a point-of-care test for the diagnosis of latent tuberculosis infection

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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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Funding

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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Authors and Affiliations

  1. Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea

    Hoon Hee Lee, Kyung-Wook Jo & Tae Sun Shim

  2. R&D Center, Boditech Med Inc., Chuncheon, South Korea

    Dong Hwan Choi

  3. Department of Research and Development, The Korean Institute of Tuberculosis, Cheongju, South Korea

    Jeong-Ran Kim

  4. AB Medical Inc., Jangseong, South Korea

    Young Gyun Kim

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  1. Hoon Hee Lee
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  2. Dong Hwan Choi
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Correspondence to Tae Sun Shim.

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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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