Parvovirus B19 transmission by a high-purity factor VIII concentrate.
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.


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.


CONCLUSIONS
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.
Wu
Chuan-ging
CG
Division of Hematology, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland 20852, USA.
Mason
Bobby
B
Jong
Julia
J
Erdman
Dean
D
McKernan
Laurel
L
Oakley
Meredith
M
Soucie
Mike
M
Evatt
Bruce
B
Yu
Mei-ying W
MY
D003001:Cloning, Molecular; D004279:DNA, Viral / Q000032:analysis / Q000097:blood*; D003902:Detergents / Q000494:pharmacology; D005169:Factor VIII / Q000302:isolation & purification / Q000627:therapeutic use*; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007075:Immunoglobulin M / Q000097:blood; D008297:Male; D008875:Middle Aged; D010322:Parvoviridae Infections / Q000097:blood / Q000635:transmission* / Q000821:virology; D016732:Parvovirus B19, Human / Q000235:genetics* / Q000276:immunology; D010802:Phylogeny; D010949:Plasma / Q000187:drug effects; D017422:Sequence Analysis, DNA; D012698:Serologic Tests / Q000379:methods; D012997:Solvents / Q000494:pharmacology
D004279:DNA, Viral; D003902:Detergents; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D012997:Solvents; D005169:Factor VIII