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Parvovirus B19 DNA in plasma pools and plasma derivatives
1Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, D-62335 Langen, Germany.
Background And Objectives:
Human parvovirus B19 (B19) has been transmitted by various plasma-derived medicinal products. The aim of this study was to determine the frequency and the level of B19 DNA contamination in plasma pools destined for fractionation and in a broad range of plasma derivatives. In addition, removal of B19 DNA by the manufacturing process was investigated in cases where corresponding samples from plasma pool and product were available.
Materials And Methods:
Plasma pool samples and blood products were tested for B19 DNA by nested polymerase chain reaction (PCR), and the viral DNA content was determined by TaqMan quantitative PCR.
Results:
Two-hundred and twenty two of 372 plasma pools for fractionation contained B19 DNA at concentrations of 10(2)-10(8) genome equivalents/ml (geq/ml). While approximately 65% of the DNA-positive plasma pools were only moderately contaminated (< 10(5) geq/ml), 35% contained > 10(6) geq/ml. High frequencies of contamination were detected in Factor VIII (79 of 91), prothrombin complex concentrates (38 of 43) and Factor IX (41 of 62), where the concentration of B19 DNA ranged between 102 and 107 geq/ml. A lower level of B19 DNA contamination was found in antithrombin III (five of 26 samples), in anti-D immunoglobulins (three of 37 samples) and in albumin (four of 51 samples), with levels ranging between 10(2) and 10(3) geq/ml. Furthermore, investigation of plasma pools for solvent/detergent plasma (S/D plasma), from two manufacturers, revealed B19 DNA in 15 of 66 batches at concentrations of 10(2)-10(8) geq/ml. Similar concentrations were detected in the corresponding final S/D plasma products. Anti-B19 immunoglobulin G (IgG) was found in plasma pools and S/D plasma at concentrations of approximately 40 IU/ml.
Conclusion:
Although positive PCR results do not necessarily reflect infectivity, these data show that B19 is a common contaminant in plasma pools and in plasma-derived medicinal products. Considering the resistance of animal parvoviruses to inactivation by heat and chemical agents, and the absence of specific information for B19, the risk of B19 transmission by plasma products should be considered. Physicians should be aware of this problem when treating patients of B19-related risk groups. The plasma fractionation industry should continue their efforts to avoid B19 contamination of plasma derivatives and develop methods which are effective in removing/inactivating parvovirus B19.
Insights
Human parvovirus B19 (B19) DNA is a frequent contaminant in plasma pools and derivatives, posing a potential risk for patients. Further efforts are needed to prevent B19 contamination in plasma-derived products.
Area of Science:
- Virology
- Biotechnology
- Public Health
Background:
- Human parvovirus B19 (B19) is known to be transmitted through plasma-derived medicinal products.
- Assessing B19 DNA contamination is crucial for ensuring the safety of these products.
Purpose of the Study:
- To determine the frequency and level of B19 DNA contamination in plasma pools and various plasma derivatives.
- To investigate the efficacy of manufacturing processes in removing B19 DNA.
Main Methods:
- Nested polymerase chain reaction (PCR) was used to detect B19 DNA.
- TaqMan quantitative PCR was employed to determine viral DNA concentrations.
- Samples from plasma pools and final products were analyzed.
Main Results:
- B19 DNA was detected in 222 of 372 plasma pools (10^2–10^8 genome equivalents/ml).
- High contamination levels were found in Factor VIII, prothrombin complex concentrates, and Factor IX.
- Lower contamination levels were observed in antithrombin III, anti-D immunoglobulins, and albumin.
Conclusions:
- B19 is a common contaminant in plasma pools and derivatives, with potential transmission risks.
- The plasma fractionation industry must continue efforts to minimize B19 contamination and develop effective inactivation methods.
- Healthcare providers should be aware of B19-related risks when treating vulnerable patient groups.