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 (R)) for detecting anti-hepatitis C virus antibodies (anti-HCV) in comparison to Architect (R).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 (R) anti-HCV were 1.31%-3.27%. The C-5-C-95 interval was -5.44%-5.03% away from C-50. LiCA (R) detected seroconversion in an average of 28.9 days and showed a mean of 3.7 (p = 0.0056) days earlier than Architect (R). 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 (R) detected 4 false-negative (0.25 parts per thousand) and 14 false-positive (0.86 parts per thousand) anti-HCV cases, while Architect (R) recorded 6 false-negative (0.37 parts per thousand) and 138 false-positive (8.46 parts per thousand) subjects, respectively. Compared to Architect (R), LiCA (R) presented a significantly better performance in specificity (99.91% vs. 99.14%, n = 16,018, p < 0.0001), positive predictive value (95.29% vs. 67.06%, n = 419, p < 0.0001), and overall accuracy (99.89% vs. 99.12%, n = 16,305, p < 0.0001), while no significant difference in sensitivity (98.61% vs. 97.91%, n = 287, p = 0.5217) and negative predictive value (99.98% vs. 99.96%, n = 15,886, p = 0.3021) was seen. An S/Co value of 3.28 was predicted to be the threshold with a positivity >= 95% for the LiCA (R) anti-HCV assay.Conclusion: LiCA (R) 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.