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Screening and confirmatory testing of cadaver organ donors for hepatitis C virus infection: a U.S. National
B J Pereira1, T L Wright, C H Schmid
1New England Organ Bank, Newton, Massachusetts.
Insights
Hepatitis C virus (HCV) RNA was found in 2.4% of organ donors. While second-generation antibody tests detect HCV RNA, their positive predictive value is limited, impacting organ transplantation decisions.
Area of Science:
- Virology
- Transplantation Immunology
- Public Health
Background:
- Hepatitis C virus (HCV) transmission via organ transplantation is a concern.
- Screening organ donors for HCV infection using anti-HCV antibody tests is standard practice.
- The actual prevalence of HCV infection and the diagnostic performance of anti-HCV tests in organ donors remain unclear.
Purpose of the Study:
- To determine the prevalence of HCV infection in cadaver organ donors.
- To evaluate the performance of anti-HCV antibody tests in detecting active HCV infection (HCV RNA).
- To assess the risk of HCV transmission to organ recipients.
Main Methods:
- Sera from 3078 cadaver organ donors were tested for anti-HCV using ELISA1.
- ELISA1-positive and a random sample of ELISA1-negative sera were further tested with ELISA2 and HCV RNA by polymerase chain reaction (PCR).
- Organ bank records were reviewed, and recipient outcomes were tracked.
Main Results:
- The prevalence of HCV RNA among organ donors was estimated at 2.4%.
- Second-generation ELISA (ELISA2) demonstrated 100% sensitivity and 100% negative predictive value for detecting HCV RNA.
- ELISA2 had 98.1% specificity but only a 55.1% positive predictive value for HCV RNA; clinical factors did not differentiate donors with or without HCV RNA.
Conclusions:
- Serum HCV RNA in organ donors accurately predicts HCV transmission risk.
- While discarding organs from ELISA2-positive donors would prevent transmission, it would also result in discarding 1.88% of otherwise usable organs.
- Further strategies are needed to balance HCV transmission prevention with organ utilization.
Abstract:
Hepatitis C virus (HCV) can be transmitted by organ transplantation. Cadaver organ donors are screened for HCV infection by testing for antibodies to HCV (anti-HCV). The prevalence of HCV infection and performance of anti-HCV tests in detecting HCV infection in organ donors are unknown. Sera from 3078 cadaver organ donors were tested for anti-HCV by a first generation enzyme-linked immunosorbent assay (ELISA1). Sera from all 137 ELISA1 positive donors and a random sample of 92 ELISA1 negative donors were tested for anti-HCV by a second generation ELISA (ELISA2) and for HCV RNA by the polymerase chain reaction. Organ bank records were reviewed for risk factors associated with HCV infection. Follow-up was available on 70 recipients of organs from 42 ELISA2 positive donors. The prevalence of HCV RNA, extrapolated to all 3078 donors, was 2.4%. Liver disease, anti-HCV and HCV RNA were detected more frequently among recipients of organs from ELISA2 positive donors with HCV RNA than from ELISA2 positive donors without HCV RNA. Among donors, the sensitivity and negative predictive value of the ELISA2 for HCV RNA were 100%. However, despite a specificity of 98.1%, the positive predictive value was only 55.1%. Clinical and laboratory characteristics did not distinguish ELISA2 positive donors with and without HCV RNA. The presence of serum HCV RNA in organ donors predicts the risk of transmission of HCV infection. Discarding organs from ELISA2 positive donors would eliminate transmission, but organs from 1.88 percent of donors would be wasted.(ABSTRACT TRUNCATED AT 250 WORDS)