中文摘要：

目的 检测混合原料血浆和凝血因子类产品中人细小病毒B19（human parvovirus B19,B19病毒）核酸,分析我国原料血浆及凝血因子类产品中B19病毒的污染情况。方法 针对B19病毒的保守区域NS1区合成引物及探针,采用Taq Man实时定量PCR法检测混合原料血浆和4类凝血因子类产品中B19病毒核酸。结果 混合原料血浆的B19病毒核酸的阳性率为59.49%（116/195）,最高浓度可达1.35×1010拷贝/ml。因子Ⅷ、凝血酶、纤维蛋白原以及凝血酶原复合物的阳性率分别为93.55%（29/31）、100%（10/10）、85.71%（6/7）和88.89%（8/9）。结论 我国混合原料血浆与凝血因子类产品中B19病毒的污染率较高,有必要进行原料血浆的B19病毒筛查,对于保障血液制品的病毒安全性具有重要意义。

英文摘要：

Objective To detect human parvovirus B19 （B19V）DNA in source plasma pools and coagulation factor products and determine its prevalence and the level of contamination. Methods A pair of primers and a probe selected from the highly conserved sequences encoding the non-structural protein（ NS1 ） of B19 were designed and synthesized. With the primer-probe combination, source plasma pools and four types of coagulation factor products were determined for B19V DNA by TaqMan real-time quantitative PCR. Results One-hundred and sixteen from 195 （59.49%） source plasma pools contained B19 DNA and concentrations up to 1.35 × 10^10 copies/ml were measured. High frequencies of contamination were detected in factor Ⅷ （29 of 31 ; 93.55% ）, thrombin （ 10 of 10; 100% ）, fibrinogen （6 of 7; 85.71% ） and prothrombin complex （8 of 9 ; 88.89% ）. Conclusion These data show that B19V is a common contaminator in Chinese source plasma pools and coagulation factor products. Thus, B19V screening in Chinese source plasma seems desirable and significant for the safety of plasma derivatives in China.