Transmission of parvovirus B19 by coagulation factor concentrates exposed to 100°C heat after lyophilization

Abstract

This prospective study indicates that very high temperatures applied to lyophilized concentrates appear to prevent the transmission of hepatitis A virus to hemophiliacs. However, B19 parvovirus still contaminates concentrates despite the use of this robust virucidal method.

Advances in the biology, diagnosis and host–pathogen interactions of parvovirus B19

“…B19 and blood-product safety B19 can be transmitted through blood transfusions and plasma-derived products (Prowse et al, 1997;Santagostino et al, 1997). Screening of blood donations for the presence of B19 DNA is not routine (Blümel et al, 2002), despite the fact that this virus is highly resilient and, like the hepatitis A virus, can withstand denaturation, even at high temperatures (Santagostino et al, 1994).…”

“…Screening of blood donations for the presence of B19 DNA is not routine (Blümel et al, 2002), despite the fact that this virus is highly resilient and, like the hepatitis A virus, can withstand denaturation, even at high temperatures (Santagostino et al, 1994). In fact, B19 can withstand processes that involve solvent/detergent treatment, lyophilization and temperatures of 100 8C for 30 min and, despite these harsh virucidal processes, still have the capacity to contaminate factor VIII and factor IX concentrates (Santagostino et al, 1997). B19 contamination of such purified blood products is particularly problematic as, in the absence of B19 IgG, the infectious potential of B19 may be enhanced (Blümel et al, 2002).…”

A linked donor-recipient study to evaluate parvovirus B19 transmission by blood component transfusion

“…[1][2][3][4][5] These cases, combined with the potential for very high B19V DNA concentrations (up to 10 12 IU/mL) in plasma donations 4 and the relative resistance of B19V to inactivation methods, 4,6 have led to B19V DNA testing of plasma donations to ensure that manufacturing plasma pools destined for plasma derivatives have a B19V DNA concentration less than or equal to 10 4 IU/mL, a limit proposed by the Food and Drug Administration (FDA). 7-9 The same limit for this so-called "in process testing" is a European regulatory requirement for anti-D immunoglobulin (Ig) preparations and plasma treated for virus inactivation.…”

Human Parvovirus B19: Molecular Virology, Clinical Features, Prevalence, Diagnosis and Control

“…In a survey of maternal-foetal medicine specialists involving 539 cases of B19-induced hydrops, death occurred after intrauterine transfusion in 6% of cases, and in 30% of cases without intrauterine transfusion (Rodis et al, 1998). Treatment of B19 infection with transfused blood is not always effective and it is imperative that one is cognisant of the potential presence of high titre B19 virus in blood products (Prowse et al, 1997;Santagostino et al, 1997).…”

“…In fact, B19 is thought to withstand processes involving solvent-detergent treatment, lyophilisation and temperatures of 100 1C for 30 min, and despite these harsh virucidal processes, still have the capacity to contaminate factor VIII and factor IX concentrates (Santagostino et al, 1997). B19 contamination of such purified blood products is particularly problematic as, in the absence of B19 IgG, the infectious potential of B19 may be enhanced (Blumel et al, 2002).…”