A new double-antigen sandwich test based on the light-initiated chemiluminescent assay for detecting anti-hepatitis C virus antibodies with high sensitivity and specificity.

Objectives: The aim of this study was to evaluate the performance of a new double-antigen sandwich test that is based on the light-initiated chemiluminescent assay (LiCA) for detecting anti-hepatitis C virus antibodies (anti-HCV) in comparison to Architect.

Methods: Analytical characteristics and diagnostic performance were tested using seroconversion panels and large pools of clinical samples. Positive results were validated by the strip immunoblot assay (RIBA) and HCV RNA.

Results: Repeatability and within-lab imprecision of LiCA anti-HCV were 1.31%-3.27%. The C-C interval was -5.44%-5.03% away from C. LiCA detected seroconversion in an average of 28.9 days and showed a mean of 3.7 ( = 0.0056) days earlier than Architect. In a pool of 239 samples with known HCV genotypes 1 to 6, both assays correctly detected all subjects. In 16,305 clinical patient sera, LiCA detected 4 false-negative (0.25‰) and 14 false-positive (0.86‰) anti-HCV cases, while Architect recorded 6 false-negative (0.37‰) and 138 false-positive (8.46‰) subjects, respectively. Compared to Architect, LiCA presented a significantly better performance in specificity (99.91% vs. 99.14%, = 16,018, < 0.0001), positive predictive value (95.29% vs. 67.06%, = 419, < 0.0001), and overall accuracy (99.89% vs. 99.12%, = 16,305, < 0.0001), while no significant difference in sensitivity (98.61% vs. 97.91%, = 287, = 0.5217) and negative predictive value (99.98% vs. 99.96%, = 15,886, = 0.3021) was seen. An S/Co value of 3.28 was predicted to be the threshold with a positivity ≥95% for the LiCA anti-HCV assay.

Conclusion: LiCA anti-HCV is a precise and fully automatic chemiluminescent assay with superior sensitivity and specificity. The assay can be used as a valuable tool to supplement the diagnosis of HCV infection.