Performance of three generations of anti-hepatitis C virus enzyme-linked immunosorbent assays in donors and patients.
BACKGROUND
Prevention of posttransfusion non-A,non-B hepatitis in recipients of blood components improved considerably with the introduction of the second-generation of hepatitis C virus (HCV) antibody tests. In 1993, third-generation HCV antibody assays were introduced in Europe.


METHODS
The performance of three generations of anti-HCV enzyme-linked immunosorbent assay (ELISA) (ELISA-1, -2, -3) was compared in routine blood donor screening (99,394 donations were tested with ELISA-1, 167,999 donations with ELISA-2, and 262,090 donations with ELISA-3) and in serial samples from nine patients with documented acute posttransfusion HCV infection.


RESULTS
Eight (0.01%) repeat donors, previously negative in ELISA-1, were found positive in ELISA-2 and were confirmed as positive in second-generation recombinant immunoblot assay and/or cDNA polymerase chain reaction. In the donor population, no difference in the sensitivity of ELISA-2 and -3 was observed. The specificity of the three generations of ELISAs was comparable (99.8, 99.7, and 99.7%). In seroconversion samples, ELISA-2 and -3 detected HCV antibodies at the same time in seven patients, but in two patients, ELISA-3 found HCV antibodies, respectively, 63 and 77 days earlier than ELISA-2 did. In the seroconversion samples, ELISA-2 and -3 were significantly more sensitive than second- and third-generation recombinant immunoblot assays.


CONCLUSIONS
ELISA-3 did not detect more HCV-infected individuals in a donor population that previously tested negative in ELISA-2, but it did detect HCV antibodies earlier in some patients with acute HCV infection. ELISA-2 and -3 were significantly more sensitive than second- and third-generation recombinant immunoblot assays.
Vrielink
H
H
Red Cross Blood Bank Amsterdam, the Netherlands.
Reesink
H W
HW
van den Burg
P J
PJ
Zaaijer
H L
HL
Cuypers
H T
HT
Lelie
P N
PN
van der Poel
C L
CL
D001782:Blood Donors; D004274:DNA, Recombinant / Q000097:blood; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D006526:Hepatitis C / Q000097:blood / Q000175:diagnosis* / Q000209:etiology; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D013997:Time Factors; D065227:Transfusion Reaction
D004274:DNA, Recombinant; D018937:Hepatitis C Antibodies