Study on screening blood donors by nucleic acid amplification technique combined with Enzyme-linked immunosorbent assay

Objective: The purpose of this study was to improve security level of clinical blood transfusion and evaluate the necessity and practicability of the testing methodology based on nucleic acid amplification technique(NAT) in addition to the regular immunoassay test(EIA). Methods: The samples tested as negative by ELISA were screened by NAT with two work flow(single detection or combined detection).The NAT-positive samples were further tested by Roche COBAS CAP_CTM system and eletro-cheniluminescence(ECL) system to evaluate the virus load and serological properties.Results: 28 NAT-positive samples were detected in the 20,925 ELISA negative donor samples.All samples were HBV DNA positive and 11 among the 28 samples were serology positive.The remaining risk of HBV infection was 0.13% under the routine EIA test.Conclusion: The risk of HBV infection still remain under the current blood donor screening method using repeated ELISA testing.The introduction of NAT test can help to reduce the risk of transfusion-transmitted disease which has a great value to increase the safety of blood.