Hepatitis A infection among patients receiving solvent/detergent inact
ivated factor VIII preparations in various locations in Europe have be
en documented recently. In investigations in Italy, Germany and Irelan
d, polymerase chain reaction (PCR) amplification was used to detect he
patitis A virus in frozen plasma pools, purified factor VIII, patient
sera and samples from animal transmission studies; nucleic acid sequen
cing was used to clarify and identify the virus responsible based upon
genotype analysis. Unique virus strains were found among the cases in
Italy and Germany, and identical virus sequences were also found in s
ome factor VIII lots. However, with the exception of the Italian inves
tigation, lack of appropriate samples have precluded the identificatio
n of virus in these outbreaks. In addition, animal infectivity studies
have not been successful in demonstrating infectivity under laborator
y conditions. We discuss the limitations of PCR amplification with res
pect to detecting virus within these situations, and the necessity for
the corresponding epidemiologic investigations.