Analysis of human parvovirus B19 nucleic acid detection in blood products in China
10.13303/j.cjbt.issn.1004-549x.2025.07.013
- VernacularTitle:血液制品中人类细小病毒B19核酸检测分析
- Author:
Yue WANG
1
;
Xiaobei ZHENG
1
;
Qin GONG
1
;
Ying ZHAO
1
;
Yuanxiu LUO
1
;
Dandan YANG
1
;
Linlin ZHANG
1
;
Zheng JIANG
1
;
Gan PENG
1
;
Jin ZHANG
1
;
Bingbing KE
2
Author Information
1. Sinopharm Wuhan Biopharmaceuticals Co., Ltd, Wuhan 430207, China
2. Hubei Institute for Drug Control, Wuhan 430075, China
- Publication Type:Journal Article
- Keywords:
human parvovirus B19;
coagulation factor products;
real-time fluorescence quantitative PCR;
nucleic acid testing;
non-lipid-enveloped virus
- From:
Chinese Journal of Blood Transfusion
2025;38(7):950-957
- CountryChina
- Language:Chinese
-
Abstract:
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 10
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 10
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 10
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.
