Record number:
557
Adverse Occurrence type:
MPHO Type:
Alerting signals, symptoms, evidence of occurrence:
Laboratory tests for HCV were performed on a cohort of patients who received a liver transplant between 1990 and 1994 at three large centers. Seven hundred twenty-two recipients and 604 donors were tested for antibody to HCV (anti-HCV) using a second-generation enzyme-linked immunoassay (EIA-2), followed by recombinant immunoblot (RIBA-2) and HCV RNA confirmation by reverse-transcription polymerase chain reaction (RT-PCR) (with genotyping and viral quantification).Fifteen donors were either anti-HCV– or HCV RNA–positive. Recipients of grafts from donors with HCV RNA all developed infection, whereas infection was not detected in recipients of grafts from donors with anti-HCV but without detectable HCV RNA. The rate of new infection fell significantly (P = .02) after the introduction of EIA-2 screening of blood.
Demonstration of imputability or root cause:
Diagnosis of posttransplantation infection required detection of serum HCV RNA that could be genotyped by sequencing or was repeatedly positive despite being unsequenceable.
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