A search for hepatitis C virus polymerase chain
reaction-positive but seronegative subjects among blood donors with
elevated alanine aminotransferase
BACKGROUND:
Previous studies reported the existence of hepatitis C virus (HCV)
polymerase chain reaction (PCR)-positive but seronegative sera.
This is not surprising in the case of window-phase specimens,
because PCR can detect HCV RNA many weeks before the appearance of
antibody. To determine whether such sera can also be found in
chronically infected subjects, a high-risk population of blood
donors with elevated alanine aminotransferase was studied.
STUDY DESIGN AND METHODS:
Freshly frozen plasma from 301 donors with alanine aminotransferase
> 100 IU per L was tested with PCR assays that were rigidly
controlled for specificity and contamination, and with current and
newer versions of assays for anti-HCV. Sera were classified as
seropositive if positive in two screening assays and one
supplemental assay or if positive in two screening assays and
PCR.
RESULTS:
New versions of screening assays detected 100 percent of
seropositive samples. A second-generation immunoblot assay detected
98 percent of seropositive sera, a second-generation recombinant
immunoblot assay detected 96 percent, and an enzyme immunoassay for
antibody to the envelope protein of HCV detected 98 percent.
Fifty-one of 54 seropositive sera were PCR positive. None of the
247 seronegative samples was reproducibly positive on PCR.
CONCLUSION:
No PCR-positive but seronegative donors were found in this
high-risk donor population. The possible benefit of PCR screening
of blood donors can be determined only by large-scale comparative
testing of donor populations and may be limited to the detection of
window-phase infections.
Author: Prince AM, Scheffel JW, Moore B, Laboratory of
Virology and Parasitology, Lindsley F. Kimball Research Institute,
New York Blood Center, New York, USA.
Source: Transfusion 37: 211-214 (1997)
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