Parvovirus B19 transmission by a high‐purity factor VIII concentrate

Wu, Chao‐Liang; Mason, Bobby L.; Jong, Julia; Erdman, Dean D.; Mckernan, L.; Oakley, Meredith; Soucie, Mike; Evatt, Bruce L.; Yu, Meng-Lin

doi:10.1111/j.1537-2995.2005.04387.x

Cited by 61 publications

(64 citation statements)

References 36 publications

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“…The minimal infectious dose of B19V DNA documented to cause a symptomatic B19V infection in a recipient of factor VIII concentrate devoid of B19V IgG was 2 ϫ 10 4 IU based on the infusion of 3 vials of a product with a DNA concentration of 6.5 ϫ 10 3 IU/vial (ie, 1.3 ϫ 10 3 IU/mL when each vial was reconstituted in a 5-mL volume). 3 Furthermore, we are aware of only one comprehensive quantitative transmission study of pooled plasma products manufactured from multiple donations. 11,32 That study, conducted approximately 10 years ago, was an open-label phase 4 trial of pooled plasma, solvent detergent-treated (PLAS ϩ SD produced by Vitex, now defunct).…”

Section: Discussionmentioning

confidence: 99%

“…[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.…”

Section: Introductionmentioning

confidence: 99%

“…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 antibody present in other plasma units in the plasma pool, or a combination of these factors.…”

Section: Introductionmentioning

confidence: 99%

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

Kleinman

Glynn

Lee

et al. 2009

Blood

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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 ...

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

Kleinman

Glynn

Lee

et al. 2009

Blood

Self Cite

View full text Add to dashboard Cite

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“…There were some reports of transfusion-transmitted B19V infec- Table 4. The results of the confirmatory test for the positive donors in both anti-B19V and B19V NAT tion through the use of tainted plasma products [13,14].…”

Section: Discussionmentioning

confidence: 99%

Investigation of the Prevalence of Human Parvovirus B19 DNA in Korean Plasmapheresis Donors

Lee

Kang

et al. 2010

Ann Lab Med

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-3.2×104 IU/mL) except for 1 donor (1.33×10 8 IU/mL). All the isolated B19V DNAs from 6 donors were identified as genotype I. Nine out of 10 B19V DNA positive donors also possessed anti-B19V IgG only or IgG and IgM. The prevalence of anti-B19V IgG was 60.1% (558/928). Conclusions :The prevalence of B19V DNA in Korean blood donors was not high and most donors also possessed neutralizing anti-B19V antibodies. Thus, the implementation of a B19V screening test for Korean blood donors does not appear to be imperative. (Korean J Lab Med 2010;30:58-64)

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“…Fetal infection following placental transfer may cause hydrops fetalis or intrauterine death (reviewed in reference 17). High prevalence means that B19V is often present in, and transmissible via, blood and blood products (2,5,6,10,16). PCR assays for this pathogen have therefore been implemented in routine blood screening and quality control of blood product manufacturing (1,3).…”

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confidence: 99%

Nuclease-Resistant Single-Stranded DNA Controls for Nucleic Acid Amplification Assays

et al. 2007

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Molecular diagnostic tests based on the PCR or alternative nucleic acid amplification technologies are commonly used for pathogen screening at blood drawing centers. Contrived process surveillance using testspecific external and internal controls is critical for the efficient leverage of PCR power. We describe here novel control constructs for use in nucleic acid amplification assays for pathogens with a single-stranded DNA genome, e.g., parvovirus B19. These controls are derived from a deletion mutant of the filamentous phage fd-tet, fKN16, and consist of single-stranded DNA packaged in a protein coat. They are essentially noninfectious to Escherichia coli and highly resistant to nuclease degradation. fKN16 based controls can be readily manufactured and highly purified. Despite their confirmed filamentous morphology, they can be precisely and accurately diluted over a wide range. Stability studies reveal that the novel control constructs are highly resistant to temperature stress, regardless of whether they are tested as concentrated stocks in storage buffer or diluted in buffer or human plasma. Real-time amplification curves derived from recombinant control constructs containing a parvovirus B19 specific sequence fragment match those derived from native virus. In summary, our data demonstrate the feasibility of novel nuclease-resistant single-stranded DNA controls as surrogates for parvovirus B19 and their applicability in routine molecular diagnostics.

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Parvovirus B19 transmission by a high‐purity factor VIII concentrate

Cited by 61 publications

References 36 publications

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

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

Investigation of the Prevalence of Human Parvovirus B19 DNA in Korean Plasmapheresis Donors

Nuclease-Resistant Single-Stranded DNA Controls for Nucleic Acid Amplification Assays

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