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Evaluation of Standard E TB-Feron Enzyme-Linked Immunosorbent Assay for Diagnosis of Latent Tuberculosis Infection in Health Care Workers.


ABSTRACT: The laboratory diagnosis of latent tuberculosis infection (LTBI) is mainly performed with interferon gamma release assays (IGRAs). We compared the performance of a new enzyme-linked immunosorbent assay (ELISA)-based IGRA, the Standard E TB-Feron ELISA (TBF; SD Biosensor, Gyeonggi-do, Republic of Korea), with that of a widely used assay, the QuantiFERON-TB Gold In-Tube assay (QFT-GIT; Qiagen, Hilden, Germany), in a population of 425 health care workers (HCWs). All HCWs were screened by both assays per the manufacturers' protocols and in a cross-manner, where tube sets from one assay were used with the alternative ELISA. The results were compared both qualitatively and quantitatively. TBF and QFT-GIT identified 11.3% (48/425) and 12.9% (55/425) of the positive samples, respectively. TBF demonstrated 81.6% positive and 97.4% negative percent agreement with QFT-GIT, with a Cohen's kappa value of 0.78 (strong agreement). Discordant results were detected in 20 subjects (4.3%): 13 samples (65.0%) were TBF negative and QFT-GIT positive, 6 samples (30.0%) were TBF positive and QFT-GIT negative, and 1 sample provided TBF and QFT-GIT indeterminate/negative results. We observed a statistically significant degree of correlation between the interferon gamma reactivity between the two assays (Spearman's rho [rs ] value = 0.551, P?

SUBMITTER: Kweon OJ 

PROVIDER: S-EPMC6879280 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Evaluation of Standard E TB-Feron Enzyme-Linked Immunosorbent Assay for Diagnosis of Latent Tuberculosis Infection in Health Care Workers.

Kweon Oh Joo OJ   Lim Yong Kwan YK   Kim Hye Ryoun HR   Kim Tae-Hyoung TH   Lee Mi-Kyung MK  

Journal of clinical microbiology 20191122 12


The laboratory diagnosis of latent tuberculosis infection (LTBI) is mainly performed with interferon gamma release assays (IGRAs). We compared the performance of a new enzyme-linked immunosorbent assay (ELISA)-based IGRA, the Standard E TB-Feron ELISA (TBF; SD Biosensor, Gyeonggi-do, Republic of Korea), with that of a widely used assay, the QuantiFERON-TB Gold In-Tube assay (QFT-GIT; Qiagen, Hilden, Germany), in a population of 425 health care workers (HCWs). All HCWs were screened by both assay  ...[more]

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