Multicenter evaluation of the new Alinity s anti-HCV II assay for routine hepatitis C virus blood screening

Background

Anti-HCV immunoassays remain the primary serologic test for HCV screening among blood donors. Since 1990s, Anti-HCV assays have evolved and those currently available detect infection earlier and have improved sensitivity and specificity compared with older generation assays. The new Alinity s Anti-HCV II assay, with its innovative design, has improved sensitivity, which shall further enhance safety of blood.

Methods

Alinity s Anti-HCV II assay was evaluated at 2 blood services (HKRCBTS & SNBTS). The overall sensitivity was evaluated using known positive samples (n = 5 at HKRCBTS; 50 at SNBTS) and 3 seroconversion panels (panel members =14 at each site). A total of 7,532 blood donor samples were tested to determine the clinical specificity.

Results

The clinical sensitivity of the new assay was found to be 100% at both sites. HCV seroconversion panel detection rates were 57.1% (8/14) and 14.3% (2/14) for the Alinity s Anti-HCV II and Anti-HCV assays respectively, resulting in an improvement in seroconversion sensitivity of 42.8% for the Anti-HCV II assay over the Anti-HCV assay. The specificity of the Anti-HCV II assay was 100% at HKRCBTS, and 99.95% at SNBTS.

Conclusions

The Anti-HCV II assay detected all known positive specimens and was able to detect samples in seroconversion panels earlier compared to the Anti-HCV assay. The assay showed excellent clinical specificity and generated fewer false-reactive results and was found to be suitable for routine blood donor screening.