Evaluation of a transcription-mediated amplification-based HCV and HIV-1 RNA duplex assay for screening individual blood donations: a comparison with a minipool testing system.

摘要: BACKGROUND : NAT was introduced for HCV RNA in 1999 to screen blood donations and improve the safety of supply. STUDY DESIGN AND METHODS The performance a multiplex HIV-1 based on transcription-mediated amplification (TMA) assessed with various sensitivity panels by screening 50,000 serologically unscreened, first-time donor plasma samples. Results were compared routine RT-PCR pools 96 samples. RESULTS TMA 95 percent ranged between 22 54 IU per mL 15 20 RNA. rate test failure 8.6 but decreased 4.7 when results two critical periods equipment malfunction excluded. Test related human error, minute control contamination, insufficient mixing reagents at extraction stage. All 31 repeatedly reactive samples (0.06%) seropositive (29) or (2) contained detectable discriminatory confirmatory RT-PCR, indicating 100 specificity. A direct comparison individual possible 27 RNA-containing Twenty-six detected pools; lack detection 1 sample due an identification error pooling stage. CONCLUSION had high specificity sensitivity.