The clinical significance of hepatitis C antibodies (anti-HCV) in a he
althy population was studied by liver function tests and liver biopsie
s. The patient population consisted of 195 (96.1%) of the 203 blood do
nors found to be either anti-HCV positive or indeterminate by a recomb
inant immunoblot assay (RIBA) during the first year of anti-HCV screen
ing of 307,606 donors in Finland using a first generation enzyme-linke
d immunosorbent assay. Alanine aminotransferase (ALT) levels in 67 don
ors reacting positively and in 128 reacting indeterminately by a secon
d generation RIBA (RIBA-4) were monitored to evaluate the prevalence o
f liver damage. Serum N-terminal type III procollagen (PIIINP) concent
rations were measured in all donors who fulfilled our criterion for po
ssible hepatitis C (ALT values over two times the normal upper limit o
n two occasions or over five times the normal upper limit on one occas
ion) and in 23 randomly selected RIBA-4 positive donors without ALT ab
normalities (control group). Two (1.6%) of the RIBA-4 indeterminate do
nors had ALT values compatible with possible hepatitis C (negative by
polymerase chain reaction) whereas there were 25 (37.3%) such individu
als among the RIBA-4 positive donors (P < 0.0005). Twenty (80%) of the
latter 25 RIBA-4 positive donors with possible hepatitis C consented
to liver biopsy. Of these 20 donors, 11 (55.0%) were found to have chr
onic persistent hepatitis, four (20.0%) mild, three (15.0%) moderate,
and two (10.0%) severe chronic active hepatitis. Serum PIIINP concentr
ations did not correlate with histological score even though the mean
concentration was significantly higher in RIBA-4 positive donors with
possible hepatitis C than in the control group (P < 0.01). We conclude
that HCV antibodies found coincidentally in Finnish donors seldom ind
icates severe liver disease. (C) 1994 Wiley-Liss, Inc.