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.

ABSTRACT:

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 C₅-C₉₅ interval was -5.44%-5.03% away from C₅₀. LiCA^® detected seroconversion in an average of 28.9 days and showed a mean of 3.7 (<

SUBMITTER: Li H 

PROVIDER: S-EPMC10704264 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature