vCJD transfusion-associated Fourth Case UK

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Location: BACLIFF, Texas, United States

My mother was murdered by what I call corporate and political homicide i.e. FOR PROFIT! she died from a rare phenotype of CJD i.e. the Heidenhain Variant of Creutzfeldt Jakob Disease i.e. sporadic, simply meaning from unknown route and source. I have simply been trying to validate her death DOD 12/14/97 with the truth. There is a route, and there is a source. There are many here in the USA. WE must make CJD and all human TSE, of all age groups 'reportable' Nationally and Internationally, with a written CJD questionnaire asking real questions pertaining to route and source of this agent. Friendly fire has the potential to play a huge role in the continued transmission of this agent via the medical, dental, and surgical arena. We must not flounder any longer. ...TSS

Thursday, September 18, 2014

Development of Dose-Response Models of Creutzfeldt-Jakob Disease Infection in Nonhuman Primates for Assessing the Risk of Transfusion-Transmitted variant Creutzfeldt-Jakob Disease

Development of Dose-Response Models of Creutzfeldt-Jakob Disease Infection in Nonhuman Primates for Assessing the Risk of Transfusion-Transmitted variant Creutzfeldt-Jakob Disease

 

Yin Huanga, Luisa Gregorib, Steven A. Andersona, David M. Asherb and Hong Yanga# + Author Affiliations

 

Office of Biostatistics & Epidemiology, U.S. Food and Drug Administration, Silver Spring, Maryland, USAa Office of Blood Research and Review, U.S. Food and Drug Administration, Silver Spring, Maryland, USAb
 
ABSTRACT
 
Estimates for the risk of transmitting variant Creutzfeldt-Jakob disease (vCJD) via blood transfusion have largely relied on data from rodent experiments, but the relationship between dose (amount of infected blood) and response (vCJD infection) has never been well quantified. The goal of this study was to develop a dose-response model based on nonhuman primate data to better estimate the likelihood of transfusion-transmitted vCJD (TTvCJD) in humans. Our model used dose-response data from nonhuman primates inoculated intracerebrally (IC) with brain tissues of patients with sporadic and familial CJD. We analyzed the data statistically using a beta-Poisson dose-response model. We further adjusted model parameters to account for the differences in infectivity between blood and brain tissue and in transmission efficiency between intravenous (IV) and IC routes to estimate dose-dependent TTvCJD infection.
 
*** The model estimates a mean infection rate of 76% among recipients who receive one unit of whole blood collected from an infected donor near the end of the incubation period. The nonhuman primate model provides estimates that are more consistent with those derived from a risk analysis of transfused non-leukoreduced red blood cells in United Kingdom compared to prior estimates based on rodent models.

 

IMPORTANCE TTvCJD was recently identified as one of three emerging infectious diseases posing the greatest immediate threat to the safety of the blood supply. Cases of TTvCJD were reported in recipients of non-leukoreduced red blood cells and coagulation Factor VIII manufactured from blood of UK donors. As the quantity of abnormal prions (the causative agent of TTvCJD) varies significantly in different blood components and products, it is necessary to quantify the dose-response relationship for a wide range of doses for the vCJD agent in transfused blood and plasma derivatives. In this paper we suggest the first mechanistic dose-response model for TTvCJD infection based on data from experiments with nonhuman primates. This new model may improve estimates of the possible risk to humans.

 

FOOTNOTES ↵#Address correspondence to Hong Yang, Hong.Yang@fda.hhs.gov Copyright © 2014, American Society for Microbiology. All Rights Reserved.

 


 

can anyone say TSEAC meeting in 2014 ???

 

negative...tss

 

Tuesday, August 26, 2014

 

Blood reference materials from macaques infected with variant Creutzfeldt-Jakob disease agent

 


 

Thursday, August 21, 2014

 

FDA Switzerland Reason For Recall Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed 2014-05-16

 


 

Friday, January 10, 2014

 

vpspr, sgss, sffi, TSE, an iatrogenic by-product of gss, ffi, familial type prion disease, what it ???

 


 

Monday, May 19, 2014

 

Variant CJD: 18 years of research and surveillance

 


 

Sunday, June 29, 2014

 

Transmissible Spongiform Encephalopathy TSE Prion Disease North America 2014

 


 

Tuesday, August 12, 2014

 

*** MAD COW USDA TSE PRION COVER UP or JUST IGNORANCE, for the record AUGUST 2014 ***

 

see history of record of either the biggest cover up of mad cow disease, or one of the biggest blunders of the mad cow debacle, just my opinion of the facts...tss

 


 

Monday, June 02, 2014

 

*** Confirmed Human BSE aka mad cow Variant CJD vCJD or nvCJD Case in Texas ***

 

WHAT IS THE BIG SECRET HERE ?

 

why no information on this case $

 

Sent: Wednesday, June 04, 2014 11:52 AM
Subject: RE: nvCJD Texas ???
 

Adult male from Texas with extensive travel history. That’s the extent of the information I can provide at this time.
 
......................................................
Carrie Williams
Director of Media Relations
512-776-7119
 
From: Terry S. Singeltary Sr. [mailto:flounder9@verizon.net]
Sent: Wednesday, June 04, 2014 11:51 AM
To: Williams,Carrie C (DSHS)
Subject: Re: nvCJD Texas ???
 
Thank you for your kind reply. can you please tell me anything else? age? sex? length of stay here in USA, diet, surgeries, blood, etc., anything???
 
kind regards, terry
 
 
Sent: Tuesday, June 03, 2014 9:08 AM
Subject: Re: nvCJD Texas ???
 
Yes, we have some info and links on our home page - www.dshs.state.tx.us

Sent from my iPhone

On Jun 2, 2014, at 8:12 PM, "Terry S. Singeltary Sr." <flounder9@verizon.net> wrote:
Greetings Carrie,
 
I am wondering if there is any validity to this news report, and if so, is there a statement from DSHS or anyone else in Texas ?
 
Published On: Mon, Jun 2nd, 2014
 
Outbreak News / US News | By Robert Herriman
 
Texas: Variant Creutzfeldt-Jakob Disease death confirmed, infection likely occurred overseas
 



http://www.theglobaldispatch.com/texas-variant-creutzfeldt-jakob-disease-death-confirmed-infection-likely-occurred-overseas-94391/




 
kind regards,
terry
 

 
Monday, June 02, 2014

 

*** Confirmed Human BSE aka mad cow Variant CJD vCJD or nvCJD Case in Texas ***

 


 

Tuesday, April 01, 2014

 

*** Questions linger in U.S. CJD cases 2005, and still do in 2014 ***

 


 

Monday, August 18, 2014

 

*** Barriers to Creutzfeldt-Jakob Disease Autopsies, California and the USA

 


 

Saturday, July 07, 2012

 

Class II, Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease ( vCJD) USA

 

Enforcement Report

 


 

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”

 


 

Friday, June 29, 2012

 

Highly Efficient Prion Transmission by Blood Transfusion

 


 

Sunday, June 3, 2012

 

A new neurological disease in primates inoculated with prion-infected blood or blood components

 


 

Sunday, March 09, 2014

 

A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease

 

FDA TSEAC CIRCUS AND TRAVELING ROAD SHOW FOR THE TSE PRION DISEASES

 


 

Sunday, April 06, 2014

 

SPORADIC CJD and the potential for zoonotic transmission there from, either directly or indirectly via friendly fire iatrogenic mode, evidence to date

 


 

Wednesday, December 11, 2013

 

*** Detection of Infectivity in Blood of Persons with Variant and Sporadic Creutzfeldt-Jakob Disease ***

 


 

what is the BIG SECRET about this recent case of nvCJD in Texas ???

 

Monday, June 02, 2014

 

*** Confirmed Human BSE aka mad cow Variant CJD vCJD or nvCJD Case in Texas

 


 

Tuesday, April 01, 2014

 

*** Questions linger in U.S. CJD cases 2005, and still do in 2014 ***

 


 

Sunday, March 09, 2014

 

A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease

 

FDA TSEAC CIRCUS AND TRAVELING ROAD SHOW FOR THE TSE PRION DISEASES

 


 

Sunday, April 06, 2014

 

SPORADIC CJD and the potential for zoonotic transmission there from, either directly or indirectly via friendly fire iatrogenic mode, evidence to date

 


 

Wednesday, September 10, 2014

 

Creutzfeldt-Jakob disease (CJD) biannual update (August 2014), with updated guidance on decontamination of gastrointestinal endoscopy equipment Research and analysis

 


 

Tuesday, September 16, 2014

 

mad cow scaremongers consumerfreedom.com December 20, 2003 article and a 2014 review

 


 

Wednesday, September 17, 2014

 

*** Cost benefit analysis of the development and use of ante-mortem tests for transmissible spongiform encephalopathies ***

 

snip... In summary, none of the respondents indicated that a live test for BSE was likely to be available in the immediate future. Nevertheless, it is known that at least three commercial companies that were not amongst the respondents are still interested in marketing a test for CJD in humans, and can legitimately be considered to have a real interest in the testing of bovines. This is no longer a priority for them however, and will probably not be progressed if they fail to gain approval for the testing of human blood.

 

snip...see full text ;

 

Wednesday, September 17, 2014
 
*** Cost benefit analysis of the development and use of ante-mortem tests for transmissible spongiform encephalopathies ***

 


 

U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001

 


 


 

Transmissible Spongiform Encephalopathy TSE Prion Disease North America 2014

 

Transmissible Spongiform Encephalopathy TSE Prion Disease have now been discovered in a wide verity of species across North America. typical C-BSE, atypical L-type BASE BSE, atypical H-type BSE, atypical H-G BSE, of the bovine, typical and atypical Scrapie strains, in sheep and goats, with atypical Nor-98 Scrapie spreading coast to coast in about 5 years. Chronic Wasting Disease CWD in cervid is slowly spreading without any stopping it in Canada and the USA and now has mutated into many different strains. Transmissible Mink Encephalopathy TME outbreaks. These Transmissible Spongiform Encephalopathy TSE Prion Disease have been silently mutating and spreading in different species in North America for decades.

 

The USDA, FDA, et al have assured us of a robust Triple BSE TSE prion Firewall, of which we now know without a doubt, that it was nothing but ink on paper. Since the 1997 mad cow feed ban in the USA, literally tons and tons of banned mad cow feed has been put out into commerce, never to return, as late as December of 2013, serious, serious breaches in the FDA mad cow feed ban have been documented. The 2004 enhanced BSE surveillance program was so flawed, that one of the top TSE prion Scientist for the CDC, Dr. Paul Brown stated ; Brown, who is preparing a scientific paper based on the latest two mad cow cases to estimate the maximum number of infected cows that occurred in the United States, said he has "absolutely no confidence in USDA tests before one year ago" because of the agency's reluctance to retest the Texas cow that initially tested positive.

 

see ;

 


 

The BSE surveillance and testing have also been proven to be flawed, and the GAO and OIG have both raised serious question as to just how flawed it has been (see GAO and OIG reports). North America has more documented TSE prion disease, in different documented species (excluding the Zoo BSE animals in the EU), then any other place on the Globe. This does not include the very likelihood that TSE prion disease in the domestic feline and canine have been exposed to high doses of the TSE prion disease vid pet food. To date, it’s still legal to include deer from cwd zone into pet food or deer food. Specified Risk Material i.e. SRM bans still being breach, as recently as just last month.

 

nvCJD or what they now call vCJD, another case documented in Texas last month, with very little information being released to the public on about this case? with still the same line of thought from federal officials, ‘it can’t happen here’, so another vCJD blamed on travel of a foreign animal disease from another country, while ignoring all the BSE TSE Prion risk factors we have here in the USA and Canada, and the time that this victim and others, do spend in the USA, and exposed to these risk factors, apparently do not count in any way with regard to risk factor. a flawed process of risk assessment.

 

sporadic CJD, along with new TSE prion disease in humans, of which the young are dying, of which long duration of illness from onset of symptoms to death have been documented, only to have a new name added to the pot of prion disease i.e. sporadic GSS, sporadic FFI, and or VPSPR. I only ponder how a familial type disease could be sporadic with no genetic link to any family member? when the USA is the only documented Country in the world to have documented two different cases of atypical H-type BSE, with one case being called atypical H-G BSE with the G meaning Genetic, with new science now showing that indeed atypical H-type BSE is very possible transmitted to cattle via oral transmission (Prion2014). sporadic CJD and VPSPR have been rising in Canada, USA, and the UK, with the same old excuse, better surveillance. You can only use that excuse for so many years, for so many decades, until one must conclude that CJD TSE prion cases are rising. a 48% incease in CJD in Canada is not just a blip or a reason of better surveillance, it is a mathematical rise in numbers. More and more we are seeing more humans exposed in various circumstance in the Hospital, Medical, Surgical arenas to the TSE Prion disease, and at the same time in North America, more and more humans are becoming exposed to the TSE prion disease via consumption of the TSE prion via deer and elk, cattle, sheep and goats, and for those that are exposed via or consumption, go on to further expose many others via the iatrogenic modes of transmission of the TSE prion disease i.e. friendly fire. I pondered this mode of transmission via the victims of sporadic FFI, sporadic GSS, could this be a iatrogenic event from someone sub-clinical with sFFI or sGSS ? what if?

 

Two decades have passed since Dr. Ironside first confirmed his first ten nvCJD victims in 1995. Ten years later, 2005, we had Dr. Gambetti and his first ten i.e. VPSPR in younger victims. now we know that indeed VPSPR is transmissible. yet all these TSE prion disease and victims in the USA and Canada are being pawned off as a spontaneous event, yet science has shown, the spontaneous theory has never been proven in any natural case of TSE prion disease, and scientist have warned, that they have now linked some sporadic CJD cases to atypical BSE, to atypical Scrapie, and to CWD, yet we don’t here about this in the public domain. We must make all human and animal TSE prion disease reportable in every age group, in ever state and internationally, we must have a serious re-evaluation and testing of the USA cattle herds, and we must ban interstate movement of all cervids. Any voluntary effort to do any of this will fail. Folks, we have let the industry run science far too long with regards to the TSE prion disease. While the industry and their lobbyist continues to funnel junk science to our decision policy makers, Rome burns. ...end

 

REFERENCES

 

Sunday, June 29, 2014

 

Transmissible Spongiform Encephalopathy TSE Prion Disease North America 2014

 


 

Tuesday, August 12, 2014

 

MAD COW USDA TSE PRION COVER UP or JUST IGNORANCE, for the record AUGUST 2014

 


 

Monday, July 28, 2014

 

Mitigating the Risk of Transmission and Environmental Contamination of Transmissible Spongiform Encephalopathies 2013 Annual Report

 


 

Wednesday, September 10, 2014

 

Creutzfeldt-Jakob disease (CJD) biannual update (August 2014), with updated guidance on decontamination of gastrointestinal endoscopy equipment

 

Research and analysis

 


 

 PLEASE REMEMBER ;

 

The Akron, Ohio-based CJD Foundation said the Center for Disease Control revised that number in October of 2004 to about one in 9,000 CJD cases per year in the population group age 55 and older.

 

HAVE YOU GOT YOUR CJD QUESTIONNAIRE ASKING REAL QUESTIONS PERTAINING TO ROUTE AND SOURCE OF THE TSE AGENT THAT KILLED YOUR LOVED ONE ???

 

if not, why not...

 

Friday, November 30, 2007

 

CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION

 


 


 

 

TSS

Tuesday, August 26, 2014

Blood reference materials from macaques infected with variant Creutzfeldt-Jakob disease agent

Blood reference materials from macaques infected with variant Creutzfeldt-Jakob disease agent

Authors




  • 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.
 
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-16
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Switzerland
 
 
 
see more ;
 
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
 
 
 
 
Saturday, July 07, 2012

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
 
Sunday, March 09, 2014
 
A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease
 
FDA TSEAC CIRCUS AND TRAVELING ROAD SHOW FOR THE TSE PRION DISEASES
 
 
Sunday, April 06, 2014
 
SPORADIC CJD and the potential for zoonotic transmission there from, either directly or indirectly via friendly fire iatrogenic mode, evidence to date
 
 
Wednesday, December 11, 2013
 
*** Detection of Infectivity in Blood of Persons with Variant and Sporadic Creutzfeldt-Jakob Disease ***
 
 
Friday, January 10, 2014
 
vpspr, sgss, sffi, TSE, an iatrogenic by-product of gss, ffi, familial type prion disease, what it ???
 
 
Monday, May 19, 2014
 
Variant CJD: 18 years of research and surveillance
 
 
Sunday, June 29, 2014
 
Transmissible Spongiform Encephalopathy TSE Prion Disease North America 2014
 
 
Tuesday, August 12, 2014
 
*** MAD COW USDA TSE PRION COVER UP or JUST IGNORANCE, for the record AUGUST 2014 ***
 
see history of record of either the biggest cover up of mad cow disease, or one of the biggest blunders of the mad cow debacle, just my opinion of the facts...tss
 
 
Monday, June 02, 2014
 
*** Confirmed Human BSE aka mad cow Variant CJD vCJD or nvCJD Case in Texas
 
 
Tuesday, April 01, 2014
 
*** Questions linger in U.S. CJD cases 2005, and still do in 2014 ***
 
 
Monday, August 18, 2014
 
*** Barriers to Creutzfeldt-Jakob Disease Autopsies, California and the USA
 
 
PLEASE REMEMBER ;
 
The Akron, Ohio-based CJD Foundation said the Center for Disease Control revised that number in October of 2004 to about one in 9,000 CJD cases per year in the population group age 55 and older.
 
HAVE YOU GOT YOUR CJD QUESTIONNAIRE ASKING REAL QUESTIONS PERTAINING TO ROUTE AND SOURCE OF THE TSE AGENT THAT KILLED YOUR LOVED ONE ???
 
if not, why not...
 
Friday, November 30, 2007
 
CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION
 
 
 
Thursday, August 21, 2014
 
FDA Switzerland Reason For Recall Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed 2014-05-16
 
 
TSS

Thursday, August 21, 2014

FDA Switzerland Reason For Recall Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed 2014-05-16

Reason For Recall Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.

 

Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-16
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Switzerland

 

 


 

 

see more ;

 

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

 

 


 

 

Saturday, July 07, 2012

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

 

 

Sunday, March 09, 2014

 

A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease

 

FDA TSEAC CIRCUS AND TRAVELING ROAD SHOW FOR THE TSE PRION DISEASES

 


 

 

Sunday, April 06, 2014

 

SPORADIC CJD and the potential for zoonotic transmission there from, either directly or indirectly via friendly fire iatrogenic mode, evidence to date

 


 

 

Wednesday, December 11, 2013

 

*** Detection of Infectivity in Blood of Persons with Variant and Sporadic Creutzfeldt-Jakob Disease ***

 


 

 

Friday, January 10, 2014

 

vpspr, sgss, sffi, TSE, an iatrogenic by-product of gss, ffi, familial type prion disease, what it ???

 


 

 

Monday, May 19, 2014

 

Variant CJD: 18 years of research and surveillance

 


 

 

Sunday, June 29, 2014

 

Transmissible Spongiform Encephalopathy TSE Prion Disease North America 2014

 


 

 

Tuesday, August 12, 2014

 

*** MAD COW USDA TSE PRION COVER UP or JUST IGNORANCE, for the record AUGUST 2014 ***

 

see history of record of either the biggest cover up of mad cow disease, or one of the biggest blunders of the mad cow debacle, just my opinion of the facts...tss

 


 

 

Monday, June 02, 2014

 

*** Confirmed Human BSE aka mad cow Variant CJD vCJD or nvCJD Case in Texas

 


 

 

Tuesday, April 01, 2014

 

*** Questions linger in U.S. CJD cases 2005, and still do in 2014 ***

 


 

 

Monday, August 18, 2014

 

*** Barriers to Creutzfeldt-Jakob Disease Autopsies, California and the USA

 


 

 

PLEASE REMEMBER ;

 

The Akron, Ohio-based CJD Foundation said the Center for Disease Control revised that number in October of 2004 to about one in 9,000 CJD cases per year in the population group age 55 and older.

 

HAVE YOU GOT YOUR CJD QUESTIONNAIRE ASKING REAL QUESTIONS PERTAINING TO ROUTE AND SOURCE OF THE TSE AGENT THAT KILLED YOUR LOVED ONE ???

 

if not, why not...

 

Friday, November 30, 2007

 

CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION

 

 


 


 

 

TSS

 

 

Friday, October 11, 2013

Removal of exogenous prion infectivity in leukoreduced red blood cells unit by a specific filter designed for human transfusion

ORIGINAL ARTICLE

 

Removal of exogenous prion infectivity in leukoreduced red blood cells unit by a specific filter designed for human transfusion

 

Nathalie Lescoutra-Etchegaray1,*, Chryslain Sumian2, Audrey Culeux1, Valérie Durand3, Patrick V. Gurgel4, Jean-Philippe Deslys3, Emmanuel E. Comoy3 Article first published online: 10 OCT 2013

 

DOI: 10.1111/trf.12420

 

© 2013 American Association of Blood Banks

 

 

 

Lescoutra-Etchegaray, N., Sumian, C., Culeux, A., Durand, V., Gurgel, P. V., Deslys, J.-P. and Comoy, E. E. (2013), Removal of exogenous prion infectivity in leukoreduced red blood cells unit by a specific filter designed for human transfusion. Transfusion. doi: 10.1111/trf.12420

 

 Author Information 1 Macopharma, Fontenay-aux-Roses, France 2 Macopharma, Tourcoing, France 3 Institute of Emerging Diseases and Innovative Therapies (iMETI), Division of Prions and Related Diseases (SEPIA), CEA, Fontenay-aux-Roses, France 4 ProMetic Biosciences, Raleigh, North Carolina *Address reprint requests to: Nathalie Lescoutra-Etchegaray, Macopharma, 18 Route du Panorama, Bâtiment 60, 92265 Fontenay-aux-Roses, France; e-mail: nathalie.lescoutra@macopharma.com.

 

This work was supported by grants from Agence Nationale de la Recherche (ANR), Project PRIONSECUR ANR05PRIB02302.

 

Publication History Article first published online: 10 OCT 2013 Manuscript Accepted: 12 JUL 2013 Manuscript Revised: 10 JUL 2013 Manuscript Received: 23 APR 2013 Funded by Agence Nationale de la Recherche (ANR). Grant Number: PRIONSECUR ANR05PRIB02302

 

Background

 

 Five cases of variant Creutzfeldt-Jakob disease (vCJD) infections were attributed to infusion of contaminated blood components, turning to real the interhuman transmissibility of this prion disease from asymptomatic carriers. Preventive policies rely on exclusion from blood donation and benefit of leukoreduction initially implemented against leukotropic viruses. In the absence of available antemortem diagnostic tests, the updated prevalence of silent vCJD infections (1/2000 in the United Kingdom) urges the necessity to enforce blood safety with more efficient active measures able to remove the remaining infectivity.

 

Study Design and Methods Several affinity resins were demonstrated to reduce high levels of brain-spiked infectivity from human leukoreduced red blood cells (L-RBCs). One was integrated in a device adapted to field constraints (volumes, duration) of human transfusion. We assessed here the ability of the resulting removal filter, termed P-Capt, to remove infectivity from human L-RBC units spiked with scrapie-infected hamster brain (≥10,000 infectious units/mL), through inoculation of hamsters with pre- and post–blood filtration samples.

 

Results Incubation periods of recipient animals suggest around a 3-log removal of brain-derived prion infectivity by filtration through the P-Capt.

 

Conclusion On brain-derived spiked infectivity, the P-Capt filter provided a performance similar to the resin packed in columns used for initial proof-of-concept studies, suggesting an appropriate scale-up to efficiently remove infectivity from an individual human blood bag. According to the ability of resin to completely remove apparent endogenous infectivity from hamster leukoreduced blood, the implementation of such a filter, now commercially available, might seriously improve blood safety toward prions.

 


 

 

Sunday, September 29, 2013

 

Recalls raise questions on safety practices for donated blood CJD TSE PRION

 


 

 

 

Sent: Monday, October 07, 2013 9:54 PM

 


 

Subject: [CJD-L] Coexistence of Distinct Prion Types Enables Conformational Evolution of Human PrPSc by Competitive Selection

 


 

 

 

 

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