PROSPECTIVE ANALYSIS OF BLOOD-DONORS FOR HIV-1 AND HCV GENOMES BY POLYMERASE-CHAIN-REACTION

Objective: Estimation of the risk of HCV and HIV transmission by blood transfusion and determination of the benefit of nucleic acid tests. D esign: Prospective study for estimation of the incidence rates of sero conversion for HCV and HIV among blood donors and determination of the benefit of nucleic acid tests to identify virus genome in the antibod y-negative infectious window period, For comparative reasons, the risk for virus transmission was calculated by adjusting the incidence rate s for the estimated duration of the infectious window period. Material and Methods: In a. unicenter study of the Blood Transfusion Center of the University of Dusseldorf 20,441 donated blood units from 7,920 su bjects who each donated blood more than once were analyzed in a time p eriod of 1 year. For virus genome detection, the PCR systems HCV Cobas Amplicor and HIV-1 Monitor were used examining pools of 20-30 samples . Results: Five donors with positive HCV virus genome detection in the antibody-negative window (equivalent to 24 per 100,000 donations) cou ld be identified. Two of the 5 donors had significant increases of ALA T activity. For comparison, the risk estimated by adjusting the incide nce rates for the duration of the infectious window is 31 per 100,000 donations. Thus, the nucleic acid screening test reduced the diagnosti c window by approximately 80%, The estimation of the residual risk of HIV transmission was not performed since one donor only with positive HIV genome was identified. Conclusions: The use of sensitive nucleic a cid screening tests for HCV genome detection does significantly reduce the risk of transfusion-transmitted HCV infection.