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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。
Objective To detect the nucleic acid of human parvovirus B19 (B19) in mixed raw blood plasma and clotting factor products, and to analyze the contamination of B19 virus in raw plasma and clotting factor products of our country. Methods Primers and probes were synthesized for the NS1 region of the conserved region of B19 virus. The B19 viral nucleic acids in mixed plasma and four types of clotting factors were detected by TaqMan real-time quantitative PCR. Results The positive rate of B19 virus nucleic acid in mixed plasma was 59.49% (116/195) and the highest concentration was 1.35 × 1010 copies / ml. The positive rates of factor Ⅷ, thrombin, fibrinogen and prothrombin complex were 93.55% (29/31), 100% (10/10), 85.71% (6/7) and 88.89% (8/9) ). Conclusion The B19 virus in the plasma and coagulation factor products of our country has a high pollution rate. It is necessary to screen the B19 virus in the plasma of the raw material, which is of great significance for ensuring the virus safety of blood products.