Analysis of human parvovirus B19 nucleic acid detection in blood products in China
[Objective] To analyze the nucleic acid load of human parvovirus B19 in major commercially available blood products in China, including human albumin, human intravenous immunoglobulin, human rabies immunoglobulin and various coagulation factor products, aiming to provide evidence for improving blood...
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Institute of Blood Transfusion of Chinese Academy of Medical Sciences
2025-07-01
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| Series: | Zhongguo shuxue zazhi |
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| Online Access: | https://www.cjbt.cn/thesisDetails#10.13303/j.cjbt.issn.1004-549x.2025.07.013&lang=en |
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| _version_ | 1849252848463773696 |
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| author | WANG Yue ZHENG Xiaobei GONG Qin ZHAO Ying LUO Yuanxiu YANG Dandan ZHANG Linlin JIANG Zheng PENG Gan ZHANG Jin KE Bingbing |
| author_facet | WANG Yue ZHENG Xiaobei GONG Qin ZHAO Ying LUO Yuanxiu YANG Dandan ZHANG Linlin JIANG Zheng PENG Gan ZHANG Jin KE Bingbing |
| author_sort | WANG Yue |
| collection | DOAJ |
| description | [Objective] To analyze the nucleic acid load of human parvovirus B19 in major commercially available blood products in China, including human albumin, human intravenous immunoglobulin, human rabies immunoglobulin and various coagulation factor products, aiming to provide evidence for improving blood product manufacturing processes and quality control of source plasma. [Methods] A total of 98 batches of coagulation factor products were tested for human parvovirus B19 nucleic acid using real-time fluorescent quantitative PCR, including 42 batches of human prothrombin complex, 35 batches of human coagulation factor Ⅷ, and 21 batches of human fibrinogen. Additionally, 6 batches of human albumin, 6 batches of human intravenous immunoglobulin, and 38 batches of human rabies immunoglobulin were tested for human parvovirus B19 nucleic acid. [Results] Human parvovirus B19 nucleic acid were undetectable in human albumin, human intravenous immunoglobulin and human rabies immunoglobulin. Among the 98 batches of coagulation factor products tested for human parvovirus B19 nucleic acid, B19 nucleic acid reactivity rate was 69.0% (29/42) for human prothrombin complex batches, but nucleic acid concentration were all significantly lower than 104 IU/mL. The reactivity rate of B19 nucleic acid in 35 batches of human coagulation factor Ⅷ was 48.6% (17/35), with nucleic acid concentration all below 104 IU/mL. The reactivity rate of B19 nucleic acid in 21 batches of human fibrinogen was 61.9% (13/21), with nucleic acid concentration all below 104 IU/mL. [Conclusion] No human parvovirus B19 has been detected in human albumin, human intravenous immunoglobulin, or human rabies immunoglobulin. Human parvovirus B19 nucleic acid may exist in commercially available coagulation factor products, highlighting the need for enhanced screening of human parvovirus B19 nucleic acid in these products. It is also recommended that B19 viral nucleic acid testing be conducted on source plasma, particularly for coagulation factor products. |
| format | Article |
| id | doaj-art-1a56b834875c492fa3cb9fb22b40eb84 |
| institution | Kabale University |
| issn | 1004-549X |
| language | zho |
| publishDate | 2025-07-01 |
| publisher | Institute of Blood Transfusion of Chinese Academy of Medical Sciences |
| record_format | Article |
| series | Zhongguo shuxue zazhi |
| spelling | doaj-art-1a56b834875c492fa3cb9fb22b40eb842025-08-20T03:56:32ZzhoInstitute of Blood Transfusion of Chinese Academy of Medical SciencesZhongguo shuxue zazhi1004-549X2025-07-0138795095710.13303/j.cjbt.issn.1004-549x.2025.07.0131004-549X(2025)7-0950-08Analysis of human parvovirus B19 nucleic acid detection in blood products in ChinaWANG Yue0ZHENG Xiaobei1GONG Qin2ZHAO Ying3LUO Yuanxiu4YANG Dandan5ZHANG Linlin6JIANG Zheng7PENG Gan8ZHANG Jin9KE Bingbing10Sinopharm Wuhan Biopharmaceuticals Co., Ltd, Wuhan 430207, ChinaSinopharm Wuhan Biopharmaceuticals Co., Ltd, Wuhan 430207, ChinaSinopharm Wuhan Biopharmaceuticals Co., Ltd, Wuhan 430207, ChinaSinopharm Wuhan Biopharmaceuticals Co., Ltd, Wuhan 430207, ChinaSinopharm Wuhan Biopharmaceuticals Co., Ltd, Wuhan 430207, ChinaSinopharm Wuhan Biopharmaceuticals Co., Ltd, Wuhan 430207, ChinaSinopharm Wuhan Biopharmaceuticals Co., Ltd, Wuhan 430207, ChinaSinopharm Wuhan Biopharmaceuticals Co., Ltd, Wuhan 430207, ChinaSinopharm Wuhan Biopharmaceuticals Co., Ltd, Wuhan 430207, ChinaSinopharm Wuhan Biopharmaceuticals Co., Ltd, Wuhan 430207, ChinaHubei Institute for Drug Control, Wuhan 430075, China[Objective] To analyze the nucleic acid load of human parvovirus B19 in major commercially available blood products in China, including human albumin, human intravenous immunoglobulin, human rabies immunoglobulin and various coagulation factor products, aiming to provide evidence for improving blood product manufacturing processes and quality control of source plasma. [Methods] A total of 98 batches of coagulation factor products were tested for human parvovirus B19 nucleic acid using real-time fluorescent quantitative PCR, including 42 batches of human prothrombin complex, 35 batches of human coagulation factor Ⅷ, and 21 batches of human fibrinogen. Additionally, 6 batches of human albumin, 6 batches of human intravenous immunoglobulin, and 38 batches of human rabies immunoglobulin were tested for human parvovirus B19 nucleic acid. [Results] Human parvovirus B19 nucleic acid were undetectable in human albumin, human intravenous immunoglobulin and human rabies immunoglobulin. Among the 98 batches of coagulation factor products tested for human parvovirus B19 nucleic acid, B19 nucleic acid reactivity rate was 69.0% (29/42) for human prothrombin complex batches, but nucleic acid concentration were all significantly lower than 104 IU/mL. The reactivity rate of B19 nucleic acid in 35 batches of human coagulation factor Ⅷ was 48.6% (17/35), with nucleic acid concentration all below 104 IU/mL. The reactivity rate of B19 nucleic acid in 21 batches of human fibrinogen was 61.9% (13/21), with nucleic acid concentration all below 104 IU/mL. [Conclusion] No human parvovirus B19 has been detected in human albumin, human intravenous immunoglobulin, or human rabies immunoglobulin. Human parvovirus B19 nucleic acid may exist in commercially available coagulation factor products, highlighting the need for enhanced screening of human parvovirus B19 nucleic acid in these products. It is also recommended that B19 viral nucleic acid testing be conducted on source plasma, particularly for coagulation factor products.https://www.cjbt.cn/thesisDetails#10.13303/j.cjbt.issn.1004-549x.2025.07.013&lang=enhuman parvovirus b19coagulation factor productsreal-time fluorescence quantitative pcrnucleic acid testingnon-lipid-enveloped virus |
| spellingShingle | WANG Yue ZHENG Xiaobei GONG Qin ZHAO Ying LUO Yuanxiu YANG Dandan ZHANG Linlin JIANG Zheng PENG Gan ZHANG Jin KE Bingbing Analysis of human parvovirus B19 nucleic acid detection in blood products in China Zhongguo shuxue zazhi human parvovirus b19 coagulation factor products real-time fluorescence quantitative pcr nucleic acid testing non-lipid-enveloped virus |
| title | Analysis of human parvovirus B19 nucleic acid detection in blood products in China |
| title_full | Analysis of human parvovirus B19 nucleic acid detection in blood products in China |
| title_fullStr | Analysis of human parvovirus B19 nucleic acid detection in blood products in China |
| title_full_unstemmed | Analysis of human parvovirus B19 nucleic acid detection in blood products in China |
| title_short | Analysis of human parvovirus B19 nucleic acid detection in blood products in China |
| title_sort | analysis of human parvovirus b19 nucleic acid detection in blood products in china |
| topic | human parvovirus b19 coagulation factor products real-time fluorescence quantitative pcr nucleic acid testing non-lipid-enveloped virus |
| url | https://www.cjbt.cn/thesisDetails#10.13303/j.cjbt.issn.1004-549x.2025.07.013&lang=en |
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