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European Journal of Clinical Microbiology & Infectious Diseases

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01-01-2021 | Tuberculosis | Original Article

High reproducibility of the interferon-gamma release assay T-SPOT.TB in serial testing

Authors: Thomas Meier, Martin Enders

Published in: European Journal of Clinical Microbiology & Infectious Diseases | Issue 1/2021

Abstract

Longitudinal studies regarding the reproducibility of Interferon-gamma release assay (IGRA) T-SPOT.TB for the diagnosis of Mycobacterium tuberculosis (M. tb) infection in serial testing are limited. We retrospectively analysed results of serially tested subjects in a medical laboratory in Germany over a time period of 14 years. From October 2004 to December 2018, a total of 5440 subjects were identified with a second T-SPOT.TB test after a median time interval of 258 days (interquartile range [IQR] 62–665). Consistently negative (n = 4520) or positive results (n = 682) were observed in 5202 (95.6%) subjects, indicating a high degree of concordance in serial testing (κ = 0.83). Test conversions occurred in 101 of 4621 (2.2%) subjects with initially negative tests. Of 819 subjects with initially positive test results, 137 (16.7%) had a test reversion which was associated with low spot numbers of the first test. Of 529 subjects retested within 1 year, only 60 (11.3%) displayed a test reversion. In subjects retested after more than 1 year, 77 of 290 (26.6%) tests reverted. This significantly higher rate of test reversions after more than 1 year was age-dependent and only observed in subjects above the age of 40 years. In the medical laboratory, the T-SPOT.TB test demonstrates a high reproducibility in serial testing.

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Title: High reproducibility of the interferon-gamma release assay T-SPOT.TB in serial testing
Authors: Thomas Meier
Martin Enders
Publication date: 01-01-2021
Publisher: Springer Berlin Heidelberg
Keywords: Tuberculosis
Tuberculosis
Interferon
Published in: European Journal of Clinical Microbiology & Infectious Diseases / Issue 1/2021
Print ISSN: 0934-9723
Electronic ISSN: 1435-4373
DOI: https://doi.org/10.1007/s10096-020-03997-3

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