Multicenter performance comparison of the hepatitis C antibody serology assay on the new Atellica integrated chemistry and immunoassay analyzer

Abstract

Background & Aims

To ensure more effective identification of individuals at risk of transmitting hepatitis C virus (HCV), the Centers for Disease Control suggest that all adults should undergo a one-time anti-HCV serological testing, driving increase in demand for high-performance, automated HCV serology assays. The Atellica CI analyzer is a new stand-alone, high-throughput integrated chemistry and immunoassay (IM) analyzer utilizing Atellica assays. This study evaluated the performance of the Atellica IM anti-HCV antibodies (aHCV) assay on the Atellica CI analyzer across 3 sites in the United States (U.S).

Methods

Precision, cutoff bias analysis and qualitative method comparison studies were performed on Atellica CI and Atellica IM analyzers. Method comparison was evaluated using serum specimens (n = 278) from aHCV positive individuals and negative individuals at increased risk for exposure to HCV, as well as 9 commercially available HCV seroconversion panels.

Result

Repeatability and reproducibility %CVs were <3.0 % and 6.5 % respectively, on the Atellica CI, and equivalent on each analyzer for samples at or above 0.80 Index. Bias in Index values around cutoff was estimated at – 7 % between the analyzers. Negative and positive agreement between the Atellica CI and Atellica IM analyzers were 100 % and 99.23 %, respectively, for aHCV samples, and 100 % for the 9 HCV seroconversion panels tested.

Conclusion

This is the first report on analytical and clinical performance of the Atellica IM aHCV assay on the Atellica CI analyzer. The findings demonstrate its reliability for HCV serological testing, its consistency with the Atellica IM analyzer and provide practical considerations for operating both analyzers interchangeably, potentially supporting workflow efficiency in a hub-and-spoke laboratory setting.