HCV genotyping of anti-HCV reactive samples by one ELISA assay and blood donor reentry study / 中国输血杂志

ABSTRACT

【Objective】 To investigate the genotype of anti-HCV reactive blood donors by one ELISA assay and provide scientific basis for the reentry of anti-HCV false positive blood donors. 【Methods】 The data of 453 blood donors reactive to antibody to HCV(anti-HCV) with one ELISA assay(third generation) were extracted via the blood donor information system of Shaoguan Central Blood Station from January 1, 2014 to December 31, 2018. The subjects were recalled to the station for the serological retest, using a 4th generation ELISA reagent, and PCR qualitative test. The PCR reactive samples were sent to the genetic testing laboratory for HCV genotyping, in order to guide diagnosis and treatment in the future. Meanwhile, those PCR negative blood donors returned to be eligible again based on the Guidelines for the Return of Reactive Blood Donors for Blood Screening. 【Results】 70.2% (318/453) of the previous anti-HCV-reactive blood donors, using a third-generation ELISA assay responded to the HCV genotyping, of which 83.0%(264/318) were negative, and 17%(54/318) positive. The profile of HCV subtypes in positive donors was HCV2a>1b>3a=6a. A little bit high false positive rate was presented by the third, and former, generation reagent than the four generation(0.41% vs 0.06%), which was confirmed by HCV RNA qualitative and HCV genotyping tests.After two rounds of reentry testing, 98 eligible blood donors returned to the blood donor team, with the return rate at 21.63% (98 / 453). 【Conclusion】 NAT or (and) HCV genotyping for anti-HCV reactive blood donors screened out by the third, and former, generation, should be carried out to permanently shield the true positive donors and reenter the negative ones.