Parvovirus B19V infection can be a serious infection for hematology patients with underlying hemolysis or compromised erythropoiesis syndromes. Although case reports of B19V transmission by blood component transfusion (as contrasted to manufactured plasma derivatives) are rare, no studies have systematically determined a rate of transmission to recipients transfused with B19V DNA-positive components. We used a linked donor and recipient repository and a sensitive, quantitative B19V DNA polymerase chain reaction (PCR) assay to assess such transmission in B19V-susceptible (ie, anti-B19V immunoglobulin G [IgG] negative) recipients. We assessed 112 B19V DNA-positive components from 105 donors (of 12 529 tested donations) transfused into a population of surgical patients with a pretransfusion B19V IgG seroprevalence of 78%. We found no transmission to 24 susceptible recipients from transfusion of components with B19V DNA at concentrations less than 10 6 IU/mL (upper 95% confidence interval, 11.7%). We found an anamnestic IgG response in one pretransfusion seropositive recipient transfused with a component containing greater than 10 10 IU/mL B19V DNA. These findings show either that transmission from components with less than 10 6 IU/mL does not occur, or, if it does, it is an uncommon event. These data do not support the need to routinely screen blood donations with a sensitive B19V DNA nucleic acid assay. (Blood. 2009;114:3677-3683)
IntroductionThere have been multiple reports of parvovirus B19 (B19V) transmission by pooled plasma products, including factor VIII concentrate and solvent-detergent-treated pooled plasma, documented by recipient seroconversion in asymptomatic cases or, less frequently, by clinical diagnosis of B19V-related disease in association with positive B19V test results. [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. 10 To achieve this B19V DNA concentration in the final plasma pool, B19V DNA screening of the plasma donations used to make the pool is performed using assays (applied in minipool format) with the ability to detect approximately 10 6 IU/mL in an input unit of plasma. 8 To date, no B19V transmissions from pooled plasma products have been documented when less than 10 3 to 10 4 IU/mL B19V DNA is present in an infused product. 3,4,[11][12][13] The reason for this lack of infectivity is not completely understood. It may be due to an inadequate amount of infused infectious virions, a neutralization effect from B19V ...