Preliminary evaluation of the TB-IGRA VIRCLIA® Monotest chemiluminescent interferon-gamma release assay: a comparative agreement study with QuantiFERON-TB Gold Plus
Abstract
ObjectivesWe evaluated the qualitative and quantitative agreement of the novel chemiluminescent TB-IGRA VIRCLIA® Monotest with QuantiFERON®-TB Gold Plus (QFT-Plus) for detecting tuberculosis infection.MethodsIn this prospective comparative study, 226 consecutive samples submitted for routine tuberculosis infection testing were analyzed using the TB-IGRA VIRCLIA® Monotest and the QFT-Plus chemiluminescence immunoassay (CLIA). Agreement between the two tests was assessed by calculating the overall agreement, positive and negative percent agreement (PPA/NPA), Cohen’s kappa (κ), Deming regression, and Bland–Altman analysis. An exploratory QFT-Plus-derived borderline range (0.20–0.70 IU/mL) was analyzed separately. Additional quantitative analyses were performed after excluding observations at the QFT-Plus upper quantification limit (10 IU/mL).ResultsOverall qualitative agreement was 92.9% (κ = 0.85; 95% confidence interval (CI), 0.79–0.92), with PPA of 90.1% (95% CI, 83.8–94.1) and NPA of 96.8% (95% CI, 91.1–98.9). Agreement was 94.25% for TB1 (κ = 0.885; 95% CI, 0.824–0.945) and 89.82% for TB2 (κ = 0.796; 95% CI, 0.718–0.875). In the borderline range, agreement decreased to 78.05% for TB1 (κ = 0.529; 95% CI, 0.289–0.769) and 69.05% for TB2 (κ = 0.316; 95% CI, 0.067–0.564), compared to 97.84 and 94.57%, respectively, for values outside this range. Deming regression slopes decreased from 3.085 to 0.811 for TB1 and from 3.146 to 0.926 for TB2 after excluding observations at the QFT-Plus upper quantification limit, with substantially narrower Bland–Altman limits of agreement.ConclusionThe TB-IGRA VIRCLIA® Monotest showed a high overall qualitative agreement with QFT-Plus, particularly outside the borderline range. Agreement decreased near the positivity threshold, particularly for TB2, supporting cautious interpretation and potential repeat or confirmatory testing of borderline results. Quantitative comparisons at high interferon-gamma (IFN-γ) concentrations were substantially influenced by the QFT-Plus upper quantification limit.
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BibTeX
@article{serrano2026preliminary,
title = {{Preliminary evaluation of the TB-IGRA VIRCLIA® Monotest chemiluminescent interferon-gamma release assay: a comparative agreement study with QuantiFERON-TB Gold Plus}},
author = {Jose Mária Serrano and Maria Aguilera-Franco and Juan Francisco Gutiérrez-Bautista and Fernando Cobo and M. J. Olivares Duran and Antonio Sampedro-Padilla and F. Ruiz and Jose Gutiérrez Fernández and José María Navarro-Mari and Javier Rodriguez-Granger},
journal = {Frontiers in Microbiology},
year = {2026},
month = oct,
doi = {10.3389/fmicb.2026.1916499},
url = {https://www.frontiersin.org/articles/10.3389/fmicb.2026.1916499},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Preliminary evaluation of the TB-IGRA VIRCLIA® Monotest chemiluminescent interferon-gamma release assay: a comparative agreement study with QuantiFERON-TB Gold Plus
AU - Jose Mária Serrano
AU - Maria Aguilera-Franco
AU - Juan Francisco Gutiérrez-Bautista
AU - Fernando Cobo
AU - M. J. Olivares Duran
AU - Antonio Sampedro-Padilla
AU - F. Ruiz
AU - Jose Gutiérrez Fernández
AU - José María Navarro-Mari
AU - Javier Rodriguez-Granger
PY - 2026
DA - 2026/10/29
JO - Frontiers in Microbiology
DO - 10.3389/fmicb.2026.1916499
UR - https://www.frontiersin.org/articles/10.3389/fmicb.2026.1916499
AB - ObjectivesWe evaluated the qualitative and quantitative agreement of the novel chemiluminescent TB-IGRA VIRCLIA® Monotest with QuantiFERON®-TB Gold Plus (QFT-Plus) for detecting tuberculosis infection.MethodsIn this prospective comparative study, 226 consecutive samples submitted for routine tuberculosis infection testing were analyzed using the TB-IGRA VIRCLIA® Monotest and the QFT-Plus chemiluminescence immunoassay (CLIA). Agreement between the two tests was assessed by calculating the overall agreement, positive and negative percent agreement (PPA/NPA), Cohen’s kappa (κ), Deming regression, and Bland–Altman analysis. An exploratory QFT-Plus-derived borderline range (0.20–0.70 IU/mL) was analyzed separately. Additional quantitative analyses were performed after excluding observations at the QFT-Plus upper quantification limit (10 IU/mL).ResultsOverall qualitative agreement was 92.9% (κ = 0.85; 95% confidence interval (CI), 0.79–0.92), with PPA of 90.1% (95% CI, 83.8–94.1) and NPA of 96.8% (95% CI, 91.1–98.9). Agreement was 94.25% for TB1 (κ = 0.885; 95% CI, 0.824–0.945) and 89.82% for TB2 (κ = 0.796; 95% CI, 0.718–0.875). In the borderline range, agreement decreased to 78.05% for TB1 (κ = 0.529; 95% CI, 0.289–0.769) and 69.05% for TB2 (κ = 0.316; 95% CI, 0.067–0.564), compared to 97.84 and 94.57%, respectively, for values outside this range. Deming regression slopes decreased from 3.085 to 0.811 for TB1 and from 3.146 to 0.926 for TB2 after excluding observations at the QFT-Plus upper quantification limit, with substantially narrower Bland–Altman limits of agreement.ConclusionThe TB-IGRA VIRCLIA® Monotest showed a high overall qualitative agreement with QFT-Plus, particularly outside the borderline range. Agreement decreased near the positivity threshold, particularly for TB2, supporting cautious interpretation and potential repeat or confirmatory testing of borderline results. Quantitative comparisons at high interferon-gamma (IFN-γ) concentrations were substantially influenced by the QFT-Plus upper quantification limit.
SN - 1664-302X
ER -