SCREENING AND CONFIRMATORY TESTING OF CADAVER ORGAN DONORS FOR HEPATITIS-C VIRUS-INFECTION - A US NATIONAL COLLABORATIVE STUDY

Hepatitis C virus (HCV) can be transmitted by organ transplantation. C adaver organ donors are screened for HCV infection by testing for anti bodies to HCV (anti-HCV). The prevalence of HCV infection and performa nce of anti-HCV tests in detecting HCV infection in organ donors are u nknown. Sera from 3078 cadaver organ donors were tested for anti-HCV b y a first generation enzyme-linked immunosorbent assay (ELISA1). Sera from all 137 ELISA1 positive donors and a random sample of 92 ELISA1 n egative donors were tested for anti-HCV by a second generation ELISA ( ELISA2) and for HCV RNA by the polymerase chain reaction. Organ bank r ecords were reviewed for risk factors associated with HCV infection. F ollow-up was available on 70 recipients of organs from 42 ELISA2 posit ive donors. The prevalence of HCV RNA, extrapolated to all 3078 donors , was 2.4%. Liver disease, anti-HCV and HCV RNA were detected more fre quently among recipients of organs from ELISA2 positive donors with HC V RNA than from ELISA2 positive donors without HCV RNA. Among donors, the sensitivity and negative predictive value of the ELISA2 for HCV RN A were 100%. However, despite a specificity of 98.1%, the positive pre dictive value was only 55.1%. Clinical and laboratory characteristics did not distinguish ELISA2 positive donors with and without HCV RNA. T he presence of serum HCV RNA in organ donors predicts the risk of tran smission of HCV infection. Discarding organs from ELISA2 positive dono rs would eliminate transmission, but organs from 1.88 percent of donor s would be wasted. To reduce waste, it is necessary to develop confirm atory tests with a higher specificity for HCV RNA than those that are currently available.