The sensitivity and specificity of two third-generation screening test
s for the detection of antibody to hepatitis C virus (anti-HCV) was ev
aluated in a side-by-side study (Abbott HCV EIA 3.0/Ortho HCV ELISA 3.
0). Specimens that were reactive in either ELISA were then retested by
the other ELISA, and confirmed by RIBA-3. The screening of 15,540 ser
um samples from healthy blood donors showed a significantly lower numb
er of reactive cases tested by Ortho (21 out of 8,805, 0.24%), than te
sted by Abbott (35 out of 6,735, 0.52%). In the side-by-side compariso
n, we found that significantly (p=0.005) more Ortho-positive samples w
ere also reactive in Abbott (14/21, 66.6%), than in Abbott followed by
Ortho (7/35, 20%). Moreover, the RIBA analysis revealed a significant
ly (p=0.014) higher number of RIBA-positive specimens among those reac
tive in Ortho 10/21 (47.6%), than among those reactive in Abbott 6/35
(17.2%), thus the former provides a greater positive predictive value.
However, we did not observed differences in the sensitivity between A
bbott and Ortho, because all RIBA-positive samples demonstrated reacti
vity in both ELISAs. (C) 1997, Ferrata Storti Foundation.