A multi-center clinical evaluation on first-in-class ROP-based IGRA for tuberculosis diagnosis.
Li Q., Huang Y., Nie L., Gao M., Zhang R., Yan J., Jia H., Fu M., He A., Ge Q., Li H., Song Y., Pang Y., Pan L., Jiang S.
Tuberculosis (TB) remains a leading global cause of death from infectious disease. Current enzyme-linked immunospot assay (ELISPOT)-based interferon-gamma release assays (IGRAs) rely on pooled synthetic peptides, which pose challenges for large-scale good manufacturing practice (GMP) production and quality control. To address these limitations, we developed recombinant overlapping peptide (ROP) technology and evaluated its diagnostic performance in a multi-center clinical trial in China (September 2021-August 2022). Two reagents, representing distinct antigen presentation pathways, demonstrated high concordance. ROP-TB showed excellent agreement with T-SPOT.TB, yielding positive, negative, and overall agreement rates of 95.29%, 93.51%, and 94.49%, respectively (κ = 0.889, p < 0.001). The sensitivity and specificity of ROP-TB were 88.03% and 76.79%. Notably, ROP-TB elicited a significantly stronger immune response amplitude in individuals with presumed latent and drug-resistant TB. Our findings suggest that ROP-TB is a viable auxiliary diagnostic and screening tool, offering performance comparable to T-SPOT.TB with enhanced detection of latent and resistant strains.