BACKGROUND: An attempt has been made to determine the minimum level of HCV nucleic acid in donors associated with infection of recipients. This is important for considerations about assay sensitivity, use of minipool versus single-donation testing, and continued use of serologic testing.
STUDY DESIGN AND METHODS: A total of 5387 specimens from the Transfusion-Transmitted Viruses Study in the 1970s were screened for antibody to HCV (anti-HCV). The outcome in recipients of seroreactive donations was examined for viremia and seroconversion. Present techniques for both groups included third-generation EIA, RIBA, quantitative RT-PCR assay, and transcription-mediated amplification (TMA) assay.
RESULTS: A total of 156 recipients of components from 180 anti-HCV-reactive donors were identified. One-hundred seven of these were HCV-naïve before transfusion and received a single, confirmed seropositive unit; 94 (88%) became infected. Eighty-five recipients had donors whose HCV RNA level was quantifiable by RT-PCR (range, 182-3,310,000 copies/mL). Eighty-three (98%) seroconverted. Of the remaining 22, a total of 10 received units positive for HCV RNA detected only by TMA; all 10 recipients seroconverted. Of the remaining 12 recipients of anti-HCV+, TMA-negative units, 1 recipient seroconverted.
CONCLUSIONS: High rates of transmission were seen at all levels of viremia, and one donor transmitted with undetectable levels in the TMA assay. Current HCV RNA testing will therefore not interdict all infectious units, even with single-donation testing, and serologic screening must be continued.