Efficacy of a hepatitis C virus core antigen enzyme-linked immunosorbent assay for the identification of 'window-phase' blood donations.
OBJECTIVE
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.


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.


RESULTS
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.


CONCLUSIONS
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.
Lee
S R
SR
Ortho Clinical Diagnostics, Raritan, NJ, USA. slee@OCDUS.JNJ.com
Peterson
J
J
Niven
P
P
Bahl
C
C
Page
E
E
DeLeys
R
R
Giordano-Schmidt
D
D
Baggett
D
D
Green
G
G
D000914:Antibodies, Viral / Q000097:blood; D001782:Blood Donors; D001803:Blood Transfusion; D004797:Enzyme-Linked Immunosorbent Assay; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D006526:Hepatitis C / Q000097:blood / Q000175:diagnosis / Q000517:prevention & control*; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D012680:Sensitivity and Specificity; D013997:Time Factors; D014758:Viral Core Proteins / Q000097:blood* / Q000276:immunology; D014766:Viremia / Q000175:diagnosis*
D000914:Antibodies, Viral; D012367:RNA, Viral; D014758:Viral Core Proteins; C069130:nucleocapsid protein, Hepatitis C virus