Detection of antibodies to hepatitis C virus in U.S. blood donors.
An enzyme immunoassay (EIA) which utilizes a solid phase coated with a recombinant antigen (c100-3) derived from the hepatitis C virus (HCV) genome was evaluated for efficacy in the detection of antibodies to HCV (anti-HCV). The sensitivity of the antibody test was demonstrated by the detection of anti-HCV in a well-characterized panel of human specimens known to contain the infectious agent of non-A, non-B hepatitis. The specificity of the anti-HCV test was evaluated by testing 6,118 serum specimens from volunteer blood donors considered to be at low risk for exposure to HCV. The specificity of the anti-HCV EIA was demonstrated to be 99.56%, since 6,069 of 6,096 specimens from this low-risk group were nonreactive. A total of 49 (0.80%) of the 6,118 specimens were repeatedly reactive in the test, and 22 (46.81%) of the 47 specimens available for additional testing were confirmed as positive for antibodies to HCV c100-3. Among commercial plasma donors, 390 (10.49%) of 3,718 specimens were repeatedly reactive in the EIA. A total of 375 (97.40%) of the 385 specimens available for further testing were confirmed as positive. These limited data indicate that the prevalence of antibodies to HCV is 0.36% (22 confirmed positives among 6,118 specimens) among volunteer blood donors and 10.08% (375 confirmed positives among 3,718 specimens) among commercial plasma donors. The importance of confirmatory testing is discussed.
Dawson
G J
GJ
Abbott Diagnostics Division, Abbott Laboratories, North Chicago, Illinois 60064.
Lesniewski
R R
RR
Stewart
J L
JL
Boardway
K M
KM
Gutierrez
R A
RA
Pendy
L
L
Johnson
R G
RG
Alcalde
X
X
Rote
K V
KV
Devare
S G
SG
D000595:Amino Acid Sequence; D000956:Antigens, Viral / Q000737:chemistry; D001782:Blood Donors; D005069:Evaluation Studies as Topic; D016174:Hepacivirus / Q000276:immunology*; D006508:Hepatitis Antibodies / Q000097:blood*; D006526:Hepatitis C / Q000175:diagnosis / Q000276:immunology / Q000635:transmission; D018937:Hepatitis C Antibodies; D006801:Humans; D007124:Immunoenzyme Techniques; D008969:Molecular Sequence Data; D010455:Peptides / Q000737:chemistry / Q000276:immunology; D065227:Transfusion Reaction; D014481:United States
D000956:Antigens, Viral; D006508:Hepatitis Antibodies; D018937:Hepatitis C Antibodies; D010455:Peptides; C078224:anti-C100-3