原料血浆人细小病毒B19流行情况调查

Investigation of the prevalence of human parvovirus B19 DNA in source plasma

目的调查原料血浆人细小病毒B19流行情况和B19 IgG抗体阳性率,评价原料血浆进行B19病毒核酸筛查的必要性。方法采用实时荧光定量PCR技术对原料血浆和投料合并血浆以及B19 DNA阳性合并血浆对应的成品进行B19 DNA检测,采用ELISA法进行IgG抗体检测,对B19 DNA阳性供血浆者进行跟踪分析。结果从10 150份原料血浆筛查出B19 DNA阳性样品3份,流行率为0.03%,阳性样品均为低浓度;810份血浆样品中367份为B19 IgG抗体阳性,阳性率45.3%,均值为9.18 IU/m L;投料合并血浆B19 DNA阳性率为23.7%,不合格率为3.39%(>104IU/m L);投料合并血浆IgG抗体含量均值为13.51 IU/m L,>11 IU/m L占88.1%。B19病毒>104IU/m L的投料合并血浆生产出的人血白蛋白和免疫球蛋白B19 DNA均为阴性。免疫球蛋白B19 IgG抗体含量均值为234 IU/m L。结论调查的原料血浆中B19 DNA流行率及载量均很低,原料血浆、投料合并血浆及免疫球蛋白中B19 IgG抗体含量较高,生产人血白蛋白和免疫球蛋白所采用的低温乙醇工艺对B19病毒具有良好的去除能力,调查中低温乙醇法生产的人血白蛋白和免疫球蛋白制品具有较高的B19病毒安全性。但原料血浆和投料合并血浆是否有必要进行B19核酸筛查,尚需更深入的研究。

Objective To investigate the prevalence of B19 DNA and the positive rate of anti-B19V IgG in source plasma and to evaluate the necessity of NAT test for B19 in source plasma.Methods B19 DNA was tested by real-time Q-PCR technology in source plasma and plasma pool for fractionation.The final products were manufactured from the positive plasma pool.Anti-B19V IgG was tested in source plasma and plasma pool by ELISA.The B19 DNA positive donors were traced and analyzed.Results The prevalence of B19V DNA in source plasma was 0.03%（3/10 150） and the viral titer of positive donor was very low.The positive rate of anti-B19V IgG in source plasma was 45.3% and the mean content of anti-B19V IgG was approximately 9.18 IU/mL.The positive rate of B19V DNA in pooled plasma for fractionation was 23.7%,with unqualified rate of 3.39% whose viral titer was more than 104 IU/mL.The mean content of anti-B19V IgG in pooled plasma for fractionation was 13.51 IU/mL and 88.1%; the viral titer was more than 11 IU/mL.Human albumin and immunoglobulin manufactured from pooled plasma with more than 104 IU/ ml B19V DNA were determined to be negative.The mean content of anti-B19V IgG in immunoglobulin was 234 IU/mL.Conclusion The prevalence of B19V DNA in source plasma and the viral titer were very low,but the content of anti-B19V IgG in source plasma,pooled plasma and immunoglobulin was high.Cold ethanol fractionation process to produce human albumin and immunoglobulin can remove B19 virus effectively.Human albumin and immunoglobulin manufactured by cold ethanol fractionation in this investigation were safe.Whether B19 NAT testing for plasma screening is necessary,further studies are needed.