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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.
Summary
A new interferon gamma-induced protein 10 (IP-10) assay, RIDASCREEN® TB, shows high agreement with existing interferon-gamma release assays (IGRAs) for detecting Mycobacterium tuberculosis infection. This novel assay may enhance sensitivity for identifying low-level immune responses.
Area of Science:
- Immunology
- Infectious Diseases
- Diagnostic Assays
Background:
- Interferon-gamma release assays (IGRAs) are standard for detecting Mycobacterium tuberculosis infection by measuring T-cell responses.
- Interferon gamma-induced protein 10 (IP-10), an interferon-inducible cytokine, may offer improved sensitivity and robustness in IGRAs.
- Evaluating novel diagnostic tools is crucial for accurate tuberculosis detection.
Purpose of the Study:
- To assess the performance of the novel IP-10-based RIDASCREEN® TB assay.
- To compare RIDASCREEN® TB against established IGRAs: T-SPOT® TB and QuantiFERON®-TB Gold Plus (QFT®-Plus).
- To determine the diagnostic accuracy of RIDASCREEN® TB in a clinical setting.
Main Methods:
- A prospective study included 209 patients undergoing routine T-SPOT® TB testing.
- T-SPOT® TB, QFT®-Plus, and RIDASCREEN® TB assays were performed on all participants.
- Assay performance was evaluated using a consensus classification based on agreement between at least two of the three assays, with percent agreement and kappa values calculated.
Main Results:
- The consensus classification identified 9.1% positive, 89.0% negative, and 1.0% equivocal samples.
- RIDASCREEN® TB demonstrated a higher positivity rate (12.9%) compared to T-SPOT® TB (8.7%) and QFT®-Plus (7.7%).
- High overall agreement with the consensus was observed for all assays: T-SPOT® TB (98.4%), QFT®-Plus (97.5%), and RIDASCREEN® TB (96.6%).
Conclusions:
- RIDASCREEN® TB exhibits high concordance with established IGRAs, suggesting its potential as a reliable diagnostic tool.
- The higher positivity rate of RIDASCREEN® TB may indicate enhanced sensitivity for detecting low-level immune responses to Mycobacterium tuberculosis.
- Further investigation is warranted to confirm specificity and clinical utility.
