AUTHOR=Li Haicong , Yang Shuo , Cao Dan , Wang Qianying , Zhang Siyu , Zhou Yi , Liu Di , Yang Ruifeng , Cui Liyan , Zhu Zhaoqin 

TITLE=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

JOURNAL=Frontiers in Cellular and Infection Microbiology

VOLUME=13

YEAR=2023

URL=https://www.frontiersin.org/journals/cellular-and-infection-microbiology/articles/10.3389/fcimb.2023.1222778

DOI=10.3389/fcimb.2023.1222778

ISSN=2235-2988

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