Efficacy of a hepatitis C virus core antigen enzyme-linked immunosorbent assay for the identification of ‘window-phase’ blood donations
Version of Record online: 28 FEB 2002
Volume 80, Issue 1, pages 19–23, January 2001
How to Cite
Lee, S. R., Peterson, J., Niven, P., Bahl, C., Page, E., DeLeys, R., Giordano-Schmidt, D., Baggett, D. and Green, G. (2001), Efficacy of a hepatitis C virus core antigen enzyme-linked immunosorbent assay for the identification of ‘window-phase’ blood donations. Vox Sanguinis, 80: 19–23. doi: 10.1046/j.1423-0410.2001.00008.x
- Issue online: 28 FEB 2002
- Version of Record online: 28 FEB 2002
- Received: 14 June 2000, revised 21 August 2000, accepted 22 August 2000
- blood donors;
- enzyme-linked immunosorbent assay (ELISA);
- HCV antigen;
- hepatitis C virus (HCV), window phase;
- viral RNA
Background and Objectives
Recent studies have suggested that potentially infectious donations provided during the antibody-negative ‘window’ phase of hepatitis C virus (HCV) infection may be identified by testing for viral RNA or HCV core protein. We therefore evaluated the performance of an HCV antigen enzyme-linked immunosorbent assay (ELISA) for identification of window-phase donations and for prospective screening of blood donors.
Materials and Methods
One-hundred and twenty-eight archived plasma donations containing HCV RNA, but lacking antibody to HCV (anti-HCV), were tested by using the HCV antigen ELISA, together with 9951 freshly collected serum and plasma specimens from blood donors.
HCV core antigen was detected in 94% (120/128) of window-phase plasma donations. Overall specificity in freshly collected blood donor specimens was 99·74%. Two putative window-phase donations containing HCV core protein and viral RNA were identified from paid plasma donors by prospective testing with the HCV antigen ELISA.
These results indicate that an HCV antigen ELISA can identify almost all (94%) of viraemic donations given during the seronegative window phase of infection. The performance of the HCV antigen ELISA appears to be suitable for large-scale screening of blood donations.