| Autor: |
Wai-Chiu Tsoi, Catriona Simpson, Lisa Jarvis, Alan Smith, Ninette Robbins, Ramune Sepetiene, Sonu Bhatnagar |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
|
| Zdroj: |
Journal of Clinical Virology Plus, Vol 3, Iss 1, Pp 100136- (2023) |
| Druh dokumentu: |
article |
| ISSN: |
2667-0380 |
| DOI: |
10.1016/j.jcvp.2023.100136 |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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