[The Technical Evaluation of HCV Screening Assay].

Area of Science:

• Virology
• Immunology
• Clinical Diagnostics

Background:

• Advances in hepatitis C treatment have increased the need for effective screening of asymptomatic carriers.
• Current hepatitis C virus (HCV) antibody screening assays exhibit variability due to differences in measurement principles and antigens used.
• Accurate and reliable HCV screening is essential for timely treatment initiation and public health management.

Purpose of the Study:

• To evaluate and compare the performance of five commercially available HCV antibody screening assays.
• To identify discrepancies in results among different HCV antibody screening platforms.
• To assess the clinical significance of discordant results and guide the development of improved screening reagents.

Main Methods:

• A comparative performance evaluation of five HCV antibody screening assays: ARCHITECT HCV, ECLusys Anti-HCV II, HISCL HCV Ab, LUMIPULSE II Ortho HCV, and LUMIPULSE Presto Ortho HCV.
• Analysis of 2,042 serum samples to determine assay sensitivity and specificity.
• Confirmatory testing was performed on samples with discordant results to assess false-positive and false-negative rates.

Main Results:

• The positive rates across the five assays varied between 3.6% and 4.5%.
• Discordant results were observed in 1.7% (35 out of 2,042) of the samples tested.
• Confirmatory testing indicated that 24 single-positive samples were likely false-positives, and 5 single-negative samples were likely true-positives.

Conclusions:

• Significant performance variations exist among current HCV antibody screening assays, impacting diagnostic accuracy.
• The study identified a notable rate of discordant results, underscoring the need for assay standardization and improvement.
• Further development of HCV antibody screening reagents is necessary to minimize non-specific reactions and ensure reliable detection of infection.