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Evaluation of a lateral flow assay-based IFN-gamma 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 (TM) 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 (TM) 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 (TM) 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 (TM) 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 (TM) 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 (TM) 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.
Author(s)
심태선조경욱Dong Hwan ChoiHoon Hee LeeJeong-Ran KimYoung Gyun Kim
Issued Date
2021
Type
Article
Keyword
MedicineMedicine & Public HealthOriginal ArticleRheumatology
DOI
10.1007/s10067-021-05663-1
URI
https://oak.ulsan.ac.kr/handle/2021.oak/7126
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_proquest_miscellaneous_2498479247&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Evaluation%20of%20a%20lateral%20flow%20assay-based%20IFN-gamma%20release%20assay%20as%20a%20point-of-care%20test%20for%20the%20diagnosis%20of%20latent%20tuberculosis%20infection&offset=0&pcAvailability=true
Publisher
CLINICAL RHEUMATOLOGY
Location
독일
Language
영어
ISSN
0770-3198
Citation Volume
40
Citation Number
9
Citation Start Page
3773
Citation End Page
3781
Appears in Collections:
Medicine > Medicine
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