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Published on: April 23, 2012
Parvovirus B19 transmission by a high-purity factor VIII concentrate
Chuan-ging Wu1, Bobby Mason, Julia Jong
1Division of Hematology, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland 20852, USA.
Background:
Parvovirus B19 (B19) is known to cause a variety of human diseases in susceptible individuals by close contact via the respiratory route or by transfusion of contaminated blood or blood products. In this study, whether a case of B19 transmission was causally related to the infusion of implicated lots of a solvent/detergent (S/D)-treated, immunoaffinity-purified factor VIII concentrate (antihemophilic factor [human][AHF]) was investigated.
Study Design And Methods:
Anti-B19 (both immunoglobulin M [IgM] and immunoglobulin G [IgG]) and B19 DNA (by a nucleic acid testing [NAT] procedure) were assayed in two implicated product lots, a plasma pool, and a recipient's serum sample. Analysis of the partial B19 sequences obtained from sequencing clones or direct sequencing of the samples was performed.
Results:
Only one of the two implicated lots was B19 DNA-positive. It contained 1.3 x 10(3) genome equivalents (geq or international units [IU]) per mL. The negative lot was derived from plasma screened for B19 DNA by NAT in a minipool format to exclude high-titer donations, whereas the positive lot was mostly from unscreened plasma. This high-purity AHF product had no detectable anti-B19 IgG. A 4-week postinfusion serum sample from a recipient, who received both lots and became ill, was positive for the presence of B19 antibodies (both IgM and IgG) as well as B19 DNA. The B19 sequences from the positive lot, its plasma pool, and the recipient's serum sample were closely related.
Conclusion:
These findings and the recipient's clinical history support a causal relationship between the implicated AHF product and B19 infection in this recipient. The seronegative patient became infected after receiving 2x10(4) IU (or geq) of B19 DNA, which was present in this S/D-treated, high-purity AHF product.
Insights
Parvovirus B19 (B19) infection was transmitted to a patient through an antihemophilic factor (AHF) concentrate. This B19 DNA-positive AHF product, derived from unscreened plasma, caused illness in the recipient.
Area of Science:
- Virology
- Hematology
- Infectious Diseases
Background:
- Parvovirus B19 (B19) causes various human diseases through respiratory contact or contaminated blood products.
- This study investigated a potential B19 transmission linked to solvent/detergent (S/D)-treated, immunoaffinity-purified factor VIII concentrate (antihemophilic factor [AHF]).
Observation:
- Two lots of AHF concentrate were tested for B19 DNA and antibodies.
- A plasma pool and a recipient's serum sample were also analyzed.
- B19 DNA was detected in one of the two implicated AHF lots.
Findings:
- The B19 DNA-positive AHF lot contained 1.3 x 10^3 genome equivalents (geq) per mL and was primarily from unscreened plasma.
- The recipient, who received both lots and became ill, tested positive for B19 antibodies (IgM and IgG) and B19 DNA post-infusion.
- Sequences from the AHF lot, plasma pool, and recipient were closely related, confirming B19 transmission.
Implications:
- The findings support a causal link between the implicated AHF product and B19 infection in the recipient.
- The patient acquired B19 infection after receiving 2x10^4 IU of B19 DNA via the AHF concentrate.
- This highlights the risk of B19 transmission through contaminated blood products, even after viral inactivation processes.
