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Field Postmortem Rabies Rapid Immunochromatographic Diagnostic Test for Resource-Limited Settings with Further Molecular Applications
Published on: June 29, 2020
Consensus-based evaluation of RIDASCREEN® TB ELISA compared with two interferon-gamma release assays in a
Kim Callebaut1, Taeyang Chin1, Jorn Hellemans1
1Department of Laboratory Medicine, Medical Microbiology, AZ Sint-Jan Brugge AV, Ruddershove 10, Brugge, 8000, Belgium.
Purpose:
Interferon-gamma release assays (IGRAs) are widely used to detect Mycobacterium tuberculosis infection by measuring antigen-specific T-cell responses through interferon-gamma (IFN-γ) release. Interferon gamma-induced protein 10 (IP-10), an IFN-inducible cytokine released in higher concentrations after antigen stimulation, may improve assay robustness and sensitivity. We evaluated the performance of the novel IP-10-based RIDASCREEN® TB in comparison with T-SPOT® TB and QuantiFERON®-TB Gold Plus (QFT®-Plus).
Methods:
In this prospective study, 209 patients undergoing routine T-SPOT® TB testing at AZ Sint-Jan Hospital Bruges were included. For each participant, T-SPOT® TB, QFT®-Plus, and RIDASCREEN® TB were performed. In the absence of a diagnostic gold standard, assay performance was assessed using a consensus classification defined by agreement between at least two of the three assays. Overall, positive, and negative percent agreement and kappa values were calculated relative to the consensus.
Results:
According to the consensus classification, 19/209 (9.1%) samples were positive, 186/209 (89.0%) negative, and 2/209 (1.0%) equivocal. Full three-way concordance was observed in 83.7% of patients, and true discordance was uncommon (7.7%). RIDASCREEN® TB showed a higher positivity rate (12.9%) than T-SPOT® TB (8.7%) and QFT®-Plus (7.7%). Agreement with the consensus classification was high for all assays, with overall percent agreement of 98.4% for T-SPOT® TB, 97.5% for QFT®-Plus, and 96.6% for RIDASCREEN® TB.
Conclusion:
RIDASCREEN® TB showed high agreement with established IGRAs and may improve detection of low-level immune responses. Its higher positivity rate may reflect increased sensitivity rather than reduced specificity.
