A search for hepatitis C virus polymerase chain
reaction-positive but seronegative subjects among blood donors with
elevated alanine aminotransferase
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
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.
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
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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