Multicenter evaluation of a commercial multiplex polymerase chain reaction test for screening plasma donations for parvovirus B19 DNA and hepatitis A virus RNA.

Background: Three European laboratories evaluated the TaqScreen DPX test (DPX test), a multiplex nucleic acid test assay for the simultaneous detection and quantitation of parvovirus B19 (B19V) DNA and the detection of hepatitis A virus (HAV) RNA.

Study Design And Methods: The 95% limit of detection of the test for B19V and HAV was determined using the respective WHO International Standards. The reproducibility of the test was evaluated by testing replicate samples of B19V at log 4.

Coxiella burnetii infection among blood donors during the 2009 Q-fever outbreak in The Netherlands.

Background: In 2007, 2008, and 2009 outbreaks of Q-fever occurred in The Netherlands with increasing magnitude. The 2009 outbreak with 2354 reported cases is the largest human Q-fever outbreak ever recorded. To assess the extent of infection and the safety of donated blood, we tested local blood donations for presence of Coxiella burnetii antibodies and DNA.

Real-time polymerase chain reaction detection of parvovirus B19 DNA in blood donations using a commercial and an in-house assay.

Background: European regulations require testing of manufacturing plasma for parvovirus B19 (B19) DNA to limit the load of this virus to a maximum acceptable level of 10 IU/µL. To meet this requirement, most manufacturers introduced a test algorithm to identify and eliminate high-load donations before making large manufacturing pools of plasma units. Sanquin screens all donations using a commercial assay from Roche and an in-house assay.

A probabilistic model for analyzing viral risks of plasma-derived medicinal products.

Background: The prevention of transmission of viral infections by plasma-derived medicinal products is of concern to manufacturers, legislators, and patient representative groups. Recent European legislation requires a viral risk assessment for all new marketing applications of such products.

Study Design And Methods: A discrete event Monte Carlo model was developed to determine the viral transmission risks of the plasma-derived medicinal products.

Diversity and origin of hepatitis C virus infection among unpaid blood donors in the Netherlands.

Background: To improve transfusion policy and to increase understanding of the spread of hepatitis C virus (HCV) in the general population, HCV infections among voluntary Dutch blood donors were examined with molecular epidemiologic techniques.

Study Design And Methods: During 6 years, 1997 through 2002, confirmed anti-HCV-positive donors were interviewed on HCV-associated risk behavior with a standardized questionnaire. Additionally, HCV isolates were genotyped, partially sequenced, and compared to sequences obtained from Dutch injecting drug users (IDUs).