R. Cable et al., LIMITED UTILITY OF ALANINE AMINOTRANSFERASE SCREENING OF HEPATITIS-C ANTIBODY-SCREENED BLOOD-DONORS, Transfusion, 37(2), 1997, pp. 206-210
BACKGROUND: The introduction of hepatitis C virus (HCV) screening has
significantly reduced the frequency of posttransfusion hepatitis C. To
examine the current added value of alanine aminotransferase (ALT) scr
eening, all donor screening at two large blood centers was reviewed. S
TUDY DESIGN AND METHODS: From July 1991 through March 1994, 1,258,000
allogeneic blood donors were screened by enzyme immunoassay for anti-H
CV: 343,000 donations by the first-generation test (HCV 1.0) and 915,0
00 donations by the second-generation test (HCV 2.0). Donations with p
ositive EIA results were confirmed with a recombinant immunoblot assay
. RESULTS: Of these donors, 1,637 (0.13%) were confirmed as HCV-positi
ve and 21,666 (1.72%) had elevated ALT. To estimate the additional mar
gin of safety due to ALT screening, all donors who seroconverted were
reviewed, and those donors who had elevated ALT but were HCV negative
on a previous donation were identified. One hundred eleven HCV serocon
versions were observed: 19 seroconversions from HCV 1.0-negative to HC
V 1.0-confirmed-positive, 82 apparent seroconversions from HCV 1.0-neg
ative to HCV 2.0-confirmed-positive, and 10 seroconversions from HCV 2
.0-negative to HCV 2.0-confirmed-positive. The number of apparent HCV
1.0-negative to HCV 2.0-positive seroconversions was much greater than
expected, which reflected the in creased sensitivity of HCV 2.0. Only
15 donors were identified who had an elevated ALT on a previous HCV-n
egative blood donation, and all of these were among those who apparent
ly seroconverted from HCV 1.0-negative to HCV 2.0-confirmed-positive.
Out of the 10 HCV 2.0-seroconverting donors, no donor was found who wa
s initially HCV 2.0 negative with elevated ALT and later was HCV 2.0 p
ositive; nor were such donors found among 4 additional HCV 2.0-serocon
verting donors. CONCLUSION: With the introduction of HCV 2.0 screening
, ALT appears to have little value as a surrogate test for hepatitis C
, and ALT testing was unable to detect any donors who later seroconver
ted, as detected by HCV 2.0.