oa Molecular Diagnosis and Vaccines - Nucleic acid testing (NAT) versus immunoassays (EIA) for detection of HBV and HCV in blood banks
High-quality coast-effective virus-free blood transfusion is the major goal in blood banks - here, a comparative evaluation of Nucleic acid testing (NAT) versus the currently implemented enzyme immunoassays (EIA) was carried out utilizing three thousands donors' samples for detection of HBV and HCV. Study design was based on obtaining two samples from each donor, a serum sample for EIA screening of HbsAg, Hbs Ab, HBcAb and HCV Ab, and plasma for NAT. Individual plasma specimens were pooled to make 125 pools (24 specimen/pool) for HBV-DNA and HCV-RNA testing. According to the results, donors pools were categorized into seven groups: Group 1; included 97 seronegative HCV Ab, among them one pool (1.03%) was found HCV-NAT positive, Group 2; included 28 seropositive HCV Ab, among them 26 (92.9%) were HCV-NAT positive, Group 3; demonstrated that the detection limit of a single HCV-PCR -positive sample per pool (> 103 IU/ml), Group 4; included 85 seronegative HBV pools, among them 5 (5.9%) were HBV-NAT positive, Group 5; included 40 pools positive only for HBc IgG and 29 (72.5%) HBV-NAT positive, Group 6; included 16 pools seropositive for HBc Ab and HBs Ab - which are allowed for transfusion an allarming result of 12.5% (2 pools) were HBV-NAT positive. Finally, group 7; demonstrated that the detection limit of one single HBV-PCR positive sample per pool was 103 copy/ml. It is concluded that, implementation of NAT screening for HBV and HCV targets in blood banks would provide more conclusive data and consequently reduce the risk of post-transfusion infections. Optimization of pooling size versus detection limit is needed specially in endemic area.
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