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Albumin batches and B19 parvovirus DNA
J J Lefrère1, M Mariotti, I De la Croix
1Institut National de Transfusion Sanguine, Hôpital Saint-Antoine, Paris, France.
Background:
B19 parvovirus (B19) may be transmitted iatrogenically by blood, and its prevalence in blood donations is estimated at 1 in 3,300 to 1 in 50,000. As a large number of blood donations make up the plasma pools used to produce plasma derivatives, even a virus as rare as B19 in a population of blood donors may result in the frequent contamination of plasma batches. The percentage of albumin batches containing B19 DNA has never been determined.
Study Design And Methods:
The presence of B19 DNA was investigated by a polymerase chain reaction assay (with a primer pair in the VP1 region) in a total of 12 and 17 batches of 4- and 20-percent albumin, respectively, from two different manufacturers.
Results:
No B19 DNA was detected in the batches tested.
Conclusion:
The current fractionation process used to obtain these albumin preparations is seen to allow the efficient degradation and/or elimination of B19.
Insights
No B19 parvovirus DNA was detected in tested albumin batches. The manufacturing process effectively removes or inactivates this virus, ensuring product safety.
Area of Science:
- Virology
- Biotechnology
- Public Health
Background:
- B19 parvovirus transmission can occur iatrogenically via blood products.
- Prevalence in blood donations ranges from 1 in 3,300 to 1 in 50,000.
- Plasma pools for derivatives may be frequently contaminated due to large donation volumes.
Purpose of the Study:
- To determine the percentage of albumin batches contaminated with B19 DNA.
- To assess the risk of B19 parvovirus transmission through albumin derivatives.
Main Methods:
- Investigated B19 DNA presence using polymerase chain reaction (PCR) assay.
- Tested 12 batches of 4% albumin and 17 batches of 20% albumin.
- Utilized a primer pair targeting the VP1 region of B19 parvovirus.
Main Results:
- B19 DNA was not detected in any of the tested albumin batches.
- This indicates a lack of contamination in the analyzed samples.
Conclusions:
- The fractionation process effectively degrades and/or eliminates B19 parvovirus.
- Current manufacturing methods ensure the safety of albumin preparations regarding B19 contamination.