Diagnostic accuracy of QuantiFERON-TB gold plus with chemiluminescence immunoassay: a systematic review and meta-analysis.

INTRODUCTION

Tuberculosis (TB) remains a global health challenge, underscoring the need for accurate diagnosis, particularly for Latent TB Infection. This meta-analysis assesses the diagnostic performance of QuantiFERON-TB Gold Plus (QFT) using Enzyme-Linked Immunosorbent Assay (ELISA) with Chemiluminescence Immunoassay (CLIA).

AREAS COVERED: We systematically reviewed studies comparing QFT-CLIA with QFT-ELISA for TB detection. The literature search was carried out on PubMed, Scopus, and Web of Science, covering publications up to 15 September 2023. We included studies that assessed sensitivity, specificity, positive and negative likelihood ratios (PLR and NLR), Diagnostic Odds Ratio (DOR), and concordance.

EXPERT OPINION: QFT-CLIA demonstrated high sensitivity of 0.97 (95% CI: 0.95-0.99) and specificity of 0.99 (95% CI: 0.92-1.0), with PLR of 72.19 (95% CI: 11.25-463.17), NLR of 0.03 (95% CI: 0.02-0.05), and DOR of 2494.55 (95% CI: 301.67 -20,627.87). The overall agreement between QFT-CLIA and QFT-ELISA was strong (0.92, 95% CI: 0.88-0.97), although the agreement for indeterminate results was slightly lower (0.83, 95% CI: 0.70-0.96). The high diagnostic accuracy and broader quantitative range of QFT-CLIA compared to ELISA may lead to more positive results and better classification of borderline cases. However, further research is needed to validate its diagnostic capabilities.