Blood reference materials from macaques infected with variant Creutzfeldt-Jakob disease agent
Blood reference materials from macaques infected with variant Creutzfeldt-Jakob disease agent
- This article reflects the views of the authors and should not be construed to represent FDA's views or policies.
- This work was supported by the US Food and Drug Administration and by an award from the FDA Office of the Chief Scientist. Part of this work was also funded by a grant from the Alliance BioSecure Foundation.
Abstract
Background
Variant Creutzfeldt-Jakob disease (vCJD) is a fatal neurodegenerative infection that can be transmitted by blood and blood products from donors in the latent phase of the disease. Currently, there is no validated antemortem vCJD blood screening test. Several blood tests are under development. Any useful test must be validated with disease-relevant blood reference panels.Study Design and Methods
To generate blood reference materials, we infected four cynomolgus macaques with macaque-adapted vCJD brain homogenates. Blood was collected throughout the preclinical and clinical phases of infection. In parallel, equivalent blood was collected from one uninfected macaque. For each blood collection, an aliquot was stored as whole blood and the remainder was separated into components. Aliquots of plasma from terminally ill macaques were assayed for the presence of PrPTSE with the protein misfolding cyclic amplification (PMCA) method. Infectivity of the macaque brain homogenate used to infect macaques was titrated in C57BL/6 and RIII J/S inbred wild-type mice.Results
We sampled blood 19 times from the inoculated monkeys at various stages of the disease over a period of 29 months, generating liters of vCJD-infected macaque blood. vCJD was confirmed in all inoculated macaques. After PMCA, PrPTSE was detected in plasma from infected monkeys, but not from uninfected animals. Both mouse models were more sensitive to infection with macaque-adapted vCJD agent than to primary human vCJD agent.Conclusion
The macaque vCJD blood panels generated in this study provide a unique resource to support vCJD assay development and to characterize vCJD infectivity in blood.http://onlinelibrary.wiley.com/enhanced/doi/10.1111/trf.12841/
Reason For Recall | Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. |
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Voluntary / Mandated | Voluntary: Firm Initiated |
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Recall Initiation Date | 2014-05-16 |
Initial Firm Notification of Consignee or Public | |
Distribution Pattern | Switzerland |
Biologics | Red Blood Cells Leukocytes Reduced | W089813410351; | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | Inova Health Care Services, Inova Blood Donor Services |
Biologics | Blood and Blood Products for Reprocessing | W089813410351; | Class III | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | Inova Health Care Services, Inova Blood Donor Services |
Biologics | Cryoprecipitated AHF | W089813410351; | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | Inova Health Care Services, Inova Blood Donor Services |
Biologics | Red Blood Cells Leukocytes Reduced | W088414515528; W088414516606; | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | Blood Bank Of Hawaii |
Class II, Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease ( vCJD) USA
Enforcement Report
http://vcjdtransfusion.blogspot.com/2012/07/class-ii-blood-products-collected-from.html
Monday, June 11, 2012
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products”
IN SHORT ;
“However, based on animal studies, as well as on FDA risk assessments, the possibility of vCJD transmission by a U.S.-licensed plasma derivative, while extremely small, cannot be absolutely ruled out. For these reasons, the recommendations for labeling for plasma derivatives will include mention of vCJD for the first time, and the potential risk for its transmission. The recommended elements of the warning label for CJD are unchanged and continue to describe its transmission as a theoretical risk, given that there is no confirmed evidence that CJD is transmitted by blood (Refs. 4-7).“
IN FULL, as follows ;
Monday, June 11, 2012
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products”
http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html
Friday, June 29, 2012
Highly Efficient Prion Transmission by Blood Transfusion
http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html
Sunday, June 3, 2012
A new neurological disease in primates inoculated with prion-infected blood or blood components
http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html