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 QFTGIT, 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.
| Original language | English (US) |
|---|---|
| Journal | Journal of Clinical Microbiology |
| Volume | 56 |
| Issue number | 7 |
| DOIs | |
| State | Published - Jul 1 2018 |
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Keywords
- IGRA
- LTBI
- QuantiFERON-TB Gold In-Tube
- QuantiFERON-TB gold plus
ASJC Scopus subject areas
- Microbiology (medical)
Cite this
Comparison of the QuantiFERON-TB gold plus and QuantiFERON-TB gold in-tube interferon gamma release assays in patients at risk for tuberculosis and in health care workers. / Theel, Elitza S.; Hilgart, Heather; Breen-Lyles, Margaret; McCoy, Kevin; Flury, Rhiannon; Breeher, Laura E.; Wilson, John; Sia, Irene Gaw; Whitaker, Jennifer A.; Clain, Jeremy; Aksamit, Timothy; Escalantec, Patricio.
In: Journal of Clinical Microbiology, Vol. 56, No. 7, 01.07.2018.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Comparison of the QuantiFERON-TB gold plus and QuantiFERON-TB gold in-tube interferon gamma release assays in patients at risk for tuberculosis and in health care workers
AU - Theel, Elitza S.
AU - Hilgart, Heather
AU - Breen-Lyles, Margaret
AU - McCoy, Kevin
AU - Flury, Rhiannon
AU - Breeher, Laura E.
AU - Wilson, John
AU - Sia, Irene Gaw
AU - Whitaker, Jennifer A.
AU - Clain, Jeremy
AU - Aksamit, Timothy
AU - Escalantec, Patricio
PY - 2018/7/1
Y1 - 2018/7/1
N2 - 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 QFTGIT, 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.
AB - 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 QFTGIT, 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.
KW - IGRA
KW - LTBI
KW - QuantiFERON-TB Gold In-Tube
KW - QuantiFERON-TB gold plus
UR - http://www.scopus.com/inward/record.url?scp=85049165628&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85049165628&partnerID=8YFLogxK
U2 - 10.1128/JCM.00614-18
DO - 10.1128/JCM.00614-18
M3 - Article
C2 - 29743310
AN - SCOPUS:85049165628
VL - 56
JO - Journal of Clinical Microbiology
JF - Journal of Clinical Microbiology
SN - 0095-1137
IS - 7
ER -