Abstract:
:The QuantiFERON-TB Gold Plus (QFT-Plus; Qiagen, Germantown, MD) interferon gamma release assay (IGRA) received FDA clearance in 2017 and will replace the prior version of the assay, the QFT-Gold In-Tube (QFT-GIT). Here, we compared performances of the QFT-Plus assay and the QFT-GIT version in a diverse patient population, including patients undergoing evaluation for or follow-up of latent tuberculosis infection (LTBI; n = 39) or active TB infection (n = 3), and in health care workers (HCWs; n = 119) at Mayo Clinic (Rochester, MN). Compared to the QFT-GIT, the QFT-Plus assay showed 91.2% (31/34) positive, 98.4% (124/126) negative, and 96.6% (156/161) overall qualitative agreement among the 161 enrolled subjects, with a Cohen's kappa value of 0.91 (excellent interrater agreement). Among the 28 patients diagnosed with LTBI at the time of enrollment, the QFT-GIT and QFT-Plus assays agreed in 24 (85.7%) patients; in all four discordant patients, the positivity of the QFT-GIT or QFT-Plus IGRA was associated with low-level interferon gamma (IFN-γ) reactivity, ranging from 0.36 IU/ml to 0.66 IU/ml. Additionally, we document a high degree of correlation between IFN-γ levels in the QFT-GIT TB antigen tube and each of the two QFT-Plus TB antigen tubes, as well as between the QFT-Plus TB1 and TB2 tubes (Pearson's correlation coefficients [R] > 0.95). Overall, we show comparable results between the QFT-GIT and QFT-Plus assays in our study population composed of subjects presenting with a diverse spectrum of TB infections. Our findings suggest that the necessary transition to the QFT-Plus assay will be associated with a minimal difference in assay performance characteristics.
journal_name
J Clin Microbioljournal_title
Journal of clinical microbiologyauthors
Theel ES,Hilgart H,Breen-Lyles M,McCoy K,Flury R,Breeher LE,Wilson J,Sia IG,Whitaker JA,Clain J,Aksamit TR,Escalante Pdoi
10.1128/JCM.00614-18subject
Has Abstractpub_date
2018-06-25 00:00:00issue
7eissn
0095-1137issn
1098-660Xpii
JCM.00614-18journal_volume
56pub_type
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journal_title:Journal of clinical microbiology
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journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.36.11.3285-3290.1998
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journal_title:Journal of clinical microbiology
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journal_title:Journal of clinical microbiology
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journal_title:Journal of clinical microbiology
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doi:10.1128/JCM.20.3.584-585.1984
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pub_type: 临床试验,杂志文章,多中心研究
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