Does the Presence of Scrapie Affect the Ability of Current Statutory 
Discriminatory Tests To Detect the Presence of Bovine Spongiform Encephalopathy? 
M. M. Simmonsa, M. J. Chaplina, C. M. Vickerya, S. Simonc, L. Davisa, M. 
Denyera, R. Lockeya*, M. J. Stackb, M. J. O'Connord, K. Bishope, K. C. Goughd, 
B. C. Maddisone, L. Thorneb and J. Spiropoulosa
aDepartment of Pathology, Animal and Plant Health Agency, Weybridge, 
Surrey, United Kingdom bDepartment of Virology, Animal and Plant Health Agency, 
Weybridge, Surrey, United Kingdom cCEA Saclay, Service de Pharmacologie et 
d'Immunoanalyse, iBiTec-S, Gif sur Yvette, France dSchool of Veterinary Medicine 
and Science, The University of Nottingham, Leicestershire, United Kingdom eADAS 
United Kingdom, School of Veterinary Medicine and Science, The University of 
Nottingham, Leicestershire, United Kingdom B. W. Fenwick, Editor + Author 
Affiliations 
ABSTRACT
Current European Commission (EC) surveillance regulations require 
discriminatory testing of all transmissible spongiform encephalopathy 
(TSE)-positive small ruminant (SR) samples in order to classify them as bovine 
spongiform encephalopathy (BSE) or non-BSE. This requires a range of tests, 
including characterization by bioassay in mouse models. Since 2005, naturally 
occurring BSE has been identified in two goats. It has also been demonstrated 
that more than one distinct TSE strain can coinfect a single animal in natural 
field situations. This study assesses the ability of the statutory methods as 
listed in the regulation to identify BSE in a blinded series of brain samples, 
in which ovine BSE and distinct isolates of scrapie are mixed at various ratios 
ranging from 99% to 1%. Additionally, these current statutory tests were 
compared with a new in vitro discriminatory method, which uses serial protein 
misfolding cyclic amplification (sPMCA). Western blotting consistently detected 
50% BSE within a mixture, but at higher dilutions it had variable success. The 
enzyme-linked immunosorbent assay (ELISA) method consistently detected BSE only 
when it was present as 99% of the mixture, with variable success at higher 
dilutions. Bioassay and sPMCA reported BSE in all samples where it was present, 
down to 1%. sPMCA also consistently detected the presence of BSE in mixtures at 
0.1%. While bioassay is the only validated method that allows comprehensive 
phenotypic characterization of an unknown TSE isolate, the sPMCA assay appears 
to offer a fast and cost-effective alternative for the screening of unknown 
isolates when the purpose of the investigation was solely to determine the 
presence or absence of BSE. 
FOOTNOTES Received 23 February 2015. Returned for modification 28 March 
2015. Accepted 27 May 2015. Accepted manuscript posted online 3 June 2015. 
Address correspondence to M. M. Simmons, marion.simmons@apha.gsi.gov.uk. ↵* 
Present address: R. Lockey, University of Southampton, Southampton, United 
Kingdom. 
Citation Simmons MM, Chaplin MJ, Vickery CM, Simon S, Davis L, Denyer M, 
Lockey R, Stack MJ, O'Connor MJ, Bishop K, Gough KC, Maddison BC, Thorne L, 
Spiropoulos J. 2015. Does the presence of scrapie affect the ability of current 
statutory discriminatory tests to detect the presence of bovine spongiform 
encephalopathy? J Clin Microbiol 53:2593–2604. doi:10.1128/JCM.00508-15. 
Copyright © 2015, American Society for Microbiology. All Rights 
Reserved.
IBNC Tauopathy or TSE Prion disease, it appears, no one is sure
Posted by flounder on 03 Jul 2015 at 16:53 GMT
HOUND STUDY
AS implied in the Inset 25 we must not _ASSUME_ that transmission of BSE to 
other species will invariably present pathology typical of a scrapie-like 
disease.
snip...
Wednesday, July 15, 2015 
Additional BSE TSE prion testing detects pathologic lesion in unusual brain 
location and PrPsc by PMCA only, how many cases have we missed?
Saturday, July 18, 2015 
SPONTANEOUS TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY TSE PRION AKA MAD COW 
TYPE DISEASE, DOES IT EXIST NATURALLY IN THE FIELD? 
Friday, July 10, 2015 
CANADA TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY TSE PRION UPDATE
Tuesday, June 23, 2015 
Report on the monitoring and testing of ruminants for the presence of 
transmissible spongiform encephalopathies (TSEs) in the EU in 2013 Final version 
18 May 2015
Wednesday, January 18, 2012 
Selection of Distinct Strain Phenotypes in Mice Infected by Ovine Natural 
Scrapie Isolates Similar to CH1641 Experimental Scrapie 
Journal of Neuropathology & Experimental Neurology: 
February 2012 - Volume 71 - Issue 2 - p 140–147
doi: 10.1097/NEN.0b013e3182439519 
Original Articles 
Selection of Distinct Strain Phenotypes in Mice Infected by Ovine Natural 
Scrapie Isolates Similar to CH1641 Experimental Scrapie 
Vulin, Johann PhD; Beck, Katy E. PhD; Bencsik, Anna PhD; Lakhdar, Latefa 
PhD; Spiropoulos, John PhD; Baron, Thierry PhD 
Supplemental Author Material 
Abstract 
Abstract: A few cases of transmissible spongiform encephalopathies in sheep 
have been described in France in which the protease-resistant prion protein 
(PrPres) exhibited some features in Western blot of experimental bovine 
spongiform encephalopathy in sheep. Their molecular characteristics were 
indistinguishable from those produced in the CH1641 experimental scrapie 
isolate. Four of these CH1641-like isolates were inoculated intracerebrally into 
wild-type C57Bl/6 mice. In striking contrast to previous results in ovine 
transgenic mice, CH1641 transmission in wild-type mice was efficient. Several 
components of the strain signature, that is, PrPres profile, brain distribution, 
and morphology of the deposits of the disease-associated prion protein, had some 
similarities with “classical” scrapie and clearly differed from both bovine 
spongiform encephalopathy in sheep and CH1641 transmission in ovine transgenic 
mice. These results on CH1641-like isolates in wild-type mice may be consistent 
with the presence in these isolates of mixed conformers with different abilities 
to propagate and mediate specific disease phenotypes in different species. 
Bovine spongiform encephalopathy, CH1641, Prion disease pathogenesis 
© 2012 American Association of Neuropathologists, Inc 
Wednesday, January 18, 2012 
BSE IN GOATS CAN BE MISTAKEN FOR SCRAPIE 
February 1, 2012 
In the US, scrapie is reported primarily in sheep homozygous for 136A/171Q 
(AAQQ) and the disease phenotype is similar to that seen with experimental 
strain CH1641. 
Thursday, July 14, 2011 
Histopathological Studies of "CH1641-Like" Scrapie Sources Versus Classical 
Scrapie and BSE Transmitted to Ovine Transgenic Mice (TgOvPrP4) 
EVIDENCE OF SCRAPIE IN SHEEP AS A RESULT OF FOOD BORNE EXPOSURE
This is provided by the statistically significant increase in the incidence 
of sheep scrape from 1985, as determined from analyses of the submissions made 
to VI Centres, and from individual case and flock incident studies. 
........
RISK OF BSE TO SHEEP VIA FEED
Marion Simmons communicated surprising evidence for oral transmissibility 
of Nor98/atypical scrapie in neonatal sheep and although bioassay is ongoing, 
infectivity of the distal ileum of 12 and 24 month infected sheep is positive in 
Tg338 mice.
SUMMARY REPORTS OF MAFF BSE TRANSMISSION STUDIES AT THE CVL ;
THE RISK TO HUMANS FROM SHEEP;
EXPERIMENTAL TRANSMISSION OF BSE TO SHEEP
SHEEP AND BSE
PERSONAL AND CONFIDENTIAL
SHEEP AND BSE
A. The experimental transmission of BSE to sheep.
Studies have shown that the ''negative'' line NPU flock of Cheviots can be 
experimentally infected with BSE by intracerebral (ic) or oral challenge (the 
latter being equivalent to 0.5 gram of a pool of four cow brains from animals 
confirmed to have BSE).
RB264
BSE - TRANSMISSION STUDIES
Monday, March 21, 2011
Sheep and Goat BSE Propagate More Efficiently than Cattle BSE in Human PrP 
Transgenic Mice
snip...
On the other hand, this component would not be distinguishable from 
bovine-passaged BSE prions due to the current limits of the standard biological 
methods and/or the molecular tools employed here to characterize prion strains. 
Whatever the mechanism, the notion that a passage through an intermediate 
species can profoundly alter prion virulence for the human species has important 
public-health issues, regarding emerging and/or expanding TSEs, like atypical 
scrapie or CWD.
snip...
Taken all together, our results suggest that the possibility of a small 
ruminant BSE prion as vCJD causal agent could not be ruled out, which has 
important implications on public and animal health policies. On one hand, 
although the exact magnitude and characteristic of the vCJD epidemic is still 
unclear, its link with cattle BSE is supported by strong epidemiological ground 
and several experimental data. On the other hand, the molecular typing performed 
in our studies, indicates that the biochemical characteristics of the PrPres 
detected in brains of our sheep and goat BSE-inoculated mice seem to be 
indistinguishable from that observed in vCJD. Considering the similarity in 
clinical manifestation of BSE- and scrapie-affected sheep [48], a masker effect 
of scrapie over BSE, as well as a potential adaptation of the BSE agent through 
subsequent passages, could not be ruled out. As BSE infected sheep PrPSc have 
been detected in many peripheral organs, small ruminant-passaged BSE prions 
might be a more widespread source of BSE infectivity compared to cattle [19], 
[49], [50]. This fact is even more worrying since our transmission studies 
suggest that apparently Met129 human PrP favours a BSE agent with ovine rather 
than a bovine sequence. Finally, it is evident that, although few natural cases 
have been described and so far we cannot draw any definitive conclusion about 
the origin of vCJD, we can not underestimate the risk of a potential goat and/or 
sheep BSE agent.
snip...
Technical Abstract:
Prion strains may vary in their ability to transmit to humans and animals. 
Few experimental studies have been done to provide evidence of differences 
between U.S. strains of scrapie, which can be distinguished by incubation times 
in inbred mice, microscopic lesions, immunoreactivity to various antibodies, or 
molecular profile (electrophoretic mobility and glycoform ratio). Recent work on 
two U.S. isolates of sheep scrapie supports that at least two distinct strains 
exist based on differences in incubation time and genotype of sheep affected. 
One isolate (No. 13-7) inoculated intracerebrally caused scrapie in sheep AA at 
codon 136 (AA136) and QQ at codon 171 (QQ171) of the prion protein in an average 
of 19 months post-inoculation (PI) whereas a second isolate (No. x124) caused 
disease in less than 12 months after oral inoculation in AV136/QQ171 sheep. 
Striking differences were evident when further strain analysis was done in R111, 
VM, C57Bl6, and C57Bl6xVM (F1) mice. No. 13-7 did not induce disease in any 
mouse strain at any time post-inoculation (PI) nor were brain tissues positive 
by western blot (WB). Positive WB results were obtained from mice inoculated 
with isolate No. x124 starting at day 380 PI. Incubation times averaged 508, 
559, 601, and 633 days PI for RIII, C57Bl6, VM, and F1 mice, respectively. 
Further passage will be required to characterize these scrapie strains in mice. 
This work provides evidence that multiple scrapie strains exist in U.S. 
sheep.
One of these isolates (TR316211) behaved like the CH1641 isolate, with 
PrPres features in mice similar to those in the sheep brain. From two other 
isolates (O100 and O104), two distinct PrPres phenotypes were identified in 
mouse brains, with either high (h-type) or low (l-type) apparent molecular 
masses of unglycosylated PrPres, the latter being similar to that observed with 
CH1641, TR316211, or BSE. Both phenotypes could be found in variable proportions 
in the brains of the individual mice. In contrast with BSE, l-type PrPres from 
"CH1641-like" isolates showed lower levels of diglycosylated PrPres. From one of 
these cases (O104), a second passage in mice was performed for two mice with 
distinct PrPres profiles. This showed a partial selection of the l-type 
phenotype in mice infected with a mouse brain with predominant l-type PrPres, 
and it was accompanied by a significant increase in the proportions of the 
diglycosylated band. These results are discussed in relation to the diversity of 
scrapie and BSE strains.
1: J Infect Dis 1980 Aug;142(2):205-8
Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to 
nonhuman primates.
Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC.
Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of sheep 
and goats were transmitted to squirrel monkeys (Saimiri sciureus) that were 
exposed to the infectious agents only by their nonforced consumption of known 
infectious tissues. The asymptomatic incubation period in the one monkey exposed 
to the virus of kuru was 36 months; that in the two monkeys exposed to the virus 
of Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and that in the 
two monkeys exposed to the virus of scrapie was 25 and 32 months, respectively. 
Careful physical examination of the buccal cavities of all of the monkeys failed 
to reveal signs or oral lesions. One additional monkey similarly exposed to kuru 
has remained asymptomatic during the 39 months that it has been under 
observation.
snip...
The successful transmission of kuru, Creutzfeldt-Jakob disease, and scrapie 
by natural feeding to squirrel monkeys that we have reported provides further 
grounds for concern that scrapie-infected meat may occasionally give rise in 
humans to Creutzfeldt-Jakob disease.
PMID: 6997404
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract 
12/10/76 AGRICULTURAL RESEARCH COUNCIL REPORT OF THE ADVISORY COMMITTE ON 
SCRAPIE Office Note CHAIRMAN: PROFESSOR PETER WILDY
snip...
A The Present Position with respect to Scrapie A] The Problem Scrapie is a 
natural disease of sheep and goats. It is a slow and inexorably progressive 
degenerative disorder of the nervous system and it ia fatal. It is enzootic in 
the United Kingdom but not in all countries. The field problem has been reviewed 
by a MAFF working group (ARC 35/77). It is difficult to assess the incidence in 
Britain for a variety of reasons but the disease causes serious financial loss; 
it is estimated that it cost Swaledale breeders alone $l.7 M during the five 
years 1971-1975. A further inestimable loss arises from the closure of certain 
export markets, in particular those of the United States, to British sheep. It 
is clear that scrapie in sheep is important commercially and for that reason 
alone effective measures to control it should be devised as quickly as possible. 
Recently the question has again been brought up as to whether scrapie is 
transmissible to man. This has followed reports that the disease has been 
transmitted to primates.
One particularly lurid speculation (Gajdusek 1977) conjectures that the 
agents of scrapie, kuru, Creutzfeldt-Jakob disease and transmissible 
encephalopathy of mink are varieties of a single "virus". The U.S. Department of 
Agriculture concluded that it could "no longer justify or permit scrapie-blood 
line and scrapie-exposed sheep and goats to be processed for human or animal 
food at slaughter or rendering plants" (ARC 84/77)" The problem is emphasised by 
the finding that some strains of scrapie produce lesions identical to the once 
which characterise the human dementias" Whether true or not. the hypothesis that 
these agents might be transmissible to man raises two considerations. First, the 
safety of laboratory personnel requires prompt attention. Second, action such as 
the "scorched meat" policy of USDA makes the solution of the acrapie problem 
urgent if the sheep industry is not to suffer grievously.
snip...
76/10.12/4.6
Nature. 1972 Mar 10;236(5341):73-4.
Transmission of scrapie to the cynomolgus monkey (Macaca 
fascicularis).
Gibbs CJ Jr, Gajdusek DC. Nature 236, 73 - 74 (10 March 1972); 
doi:10.1038/236073a0
Transmission of Scrapie to the Cynomolgus Monkey (Macaca 
fascicularis)
C. J. GIBBS jun. & D. C. GAJDUSEK National Institute of Neurological 
Diseases and Stroke, National Institutes of Health, Bethesda, Maryland
SCRAPIE has been transmitted to the cynomolgus, or crab-eating, monkey 
(Macaca fascicularis) with an incubation period of more than 5 yr from the time 
of intracerebral inoculation of scrapie-infected mouse brain. The animal 
developed a chronic central nervous system degeneration, with ataxia, tremor and 
myoclonus with associated severe scrapie-like pathology of intensive astroglial 
hypertrophy and proliferation, neuronal vacuolation and status spongiosus of 
grey matter. The strain of scrapie virus used was the eighth passage in Swiss 
mice (NIH) of a Compton strain of scrapie obtained as ninth intracerebral 
passage of the agent in goat brain, from Dr R. L. Chandler (ARC, Compton, 
Berkshire).
Wednesday, February 16, 2011
IN CONFIDENCE SCRAPIE TRANSMISSION TO CHIMPANZEES
IN CONFIDENCE
Wednesday, February 16, 2011 IN CONFIDENCE SCRAPIE TRANSMISSION TO 
CHIMPANZEES
IN CONFIDENCE
reference...
RB3.20
TRANSMISSION TO CHIMPANZEES
1. Kuru and CJD have been successfully transmitted to chimpanzees but 
scrapie and TME have not.
2. We cannot say that scrapie will not transmit to chimpanzees. There are 
several scrapie strains and I am not aware that all have been tried (that would 
have to be from mouse passaged material). Nor has a wide enough range of field 
isolates subsequently strain typed in mice been inoculated by the appropriate 
routes (i/c, ilp and i/v) :
3. I believe the proposed experiment to determine transmissibility, if 
conducted, would only show the susceptibility or resistance of the chimpanzee to 
infection/disease by the routes used and the result could not be interpreted for 
the predictability of the susceptibility for man. Proposals for prolonged oral 
exposure of chimpanzees to milk from cattle were suggested a long while ago and 
rejected.
4. In view of Dr Gibbs' probable use of chimpazees Mr Wells' comments 
(enclosed) are pertinent. I have yet to receive a direct communication from Dr 
Schellekers but before any collaboration or provision of material we should 
identify the Gibbs' proposals and objectives.
5. A positive result from a chimpanzee challenged severely would likely 
create alarm in some circles even if the result could not be interpreted for 
man. I have a view that all these agents could be transmitted provided a large 
enough dose by appropriate routes was given and the animals kept long enough. 
Until the mechanisms of the species barrier are more clearly understood it might 
be best to retain that hypothesis.
6. A negative result would take a lifetime to determine but that would be a 
shorter period than might be available for human exposure and it would still not 
answer the question regarding mans' susceptibility. In the meantime no doubt the 
negativity would be used defensively. It would however be counterproductive if 
the experiment finally became positive. We may learn more about public reactions 
following next Monday' s meeting.
R. Bradley
23 September 1990
CVO (+Mr Wells' comments)
Dr T W A Little
Dr B J Shreeve
90/9.23/1.1.
IN CONFIDENCE CHIMPANZEES
CODE 18-77 Reference RB3.46
Some further information that may assist in decision making has been gained 
by discussion with Dr Rosalind Ridley.
She says that careful study of Gajdusek's work shows no increased 
susceptibility of chimpanzees over New World Monkeys such as Squirrel Monkeys. 
She does not think it would tell you anything about the susceptibility to man. 
Also Gajdusek did not, she believes, challenge chimpanzees with scrapie as 
severely as we did pigs and we know little of that source of scrapie. 
Comparisons would be difficult. She also would not expect the Home Office to 
sanction such experiments here unless there was a very clear and important 
objective that would be important for human health protection. She doubted such 
a case could be made. If this is the case she thought it would be unethical to 
do an experiment abroad because we could not do it in our own country.
Retrospectively she feels they should have put up more marmosets than they 
did. They all remain healthy. They would normally regard the transmission as 
negative if no disease resulted in five years.
We are not being asked for a decision but I think that before we made one 
we should gain as much knowledge as we can. If we decided to proceed we would 
have to bear any criticisms for many years if there was an adverse view by 
scientists ormedia. This should not be undertaken lightly. There is already 
some adverse comment here, I gather, on the pig experiment though that will 
subside.
The Gibbs' (as' distinct from Schellekers') study is somewhat different. We 
are merely supplying material for comparative studies in a laboratory with the 
greatest experience of human SEs in the world and it has been sanctioned by USDA 
(though we do not know for certain yet if chimpanzees specifically will be 
used). This would keep it at a lower profile than if we conducted such an 
experiment in the UK or Europe.
I consider we must have very powerful and defendable objectives to go 
beyond Gibbs' proposed experiments and should not initiate others just because 
an offer has been made.
Scientists have a responsibility to seek other methods of investigative 
research other than animal experimentation. At present no objective has 
convinced me we need to do research using Chimpanzees - a species in need of 
protection. Resisting such proposals would enable us to communicate that 
information to the scientist and the public should the need arise. A line would 
have been drawn.
CVO cc Dr T Dr B W A Little Dr B J Shreeve
R Bradley
26 September 1990
90/9.26/3.2
SNIP...SEE FULL TEXT ; 
PRION 2015 ORAL AND POSTER CONGRESSIONAL ABSTRACTS
THANK YOU PRION 2015 TAYLOR & FRANCIS, Professor Chernoff, and 
Professor Aguzzi et al, for making these PRION 2015 Congressional Poster and 
Oral Abstracts available freely to the public. ...Terry S. Singeltary Sr. 
O.05: Transmission of prions to primates after extended silent incubation 
periods: Implications for BSE and scrapie risk assessment in human populations 
Emmanuel Comoy, Jacqueline Mikol, Val erie Durand, Sophie Luccantoni, 
Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys 
Atomic Energy Commission; Fontenay-aux-Roses, France 
Prion diseases (PD) are the unique neurodegenerative proteinopathies 
reputed to be transmissible under field conditions since decades. The 
transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that 
an animal PD might be zoonotic under appropriate conditions. Contrarily, in the 
absence of obvious (epidemiological or experimental) elements supporting a 
transmission or genetic predispositions, PD, like the other proteinopathies, are 
reputed to occur spontaneously (atpical animal prion strains, sporadic CJD 
summing 80% of human prion cases). Non-human primate models provided the first 
evidences supporting the transmissibiity of human prion strains and the zoonotic 
potential of BSE. Among them, cynomolgus macaques brought major information for 
BSE risk assessment for human health (Chen, 2014), according to their 
phylogenetic proximity to humans and extended lifetime. We used this model to 
assess the zoonotic potential of other animal PD from bovine, ovine and cervid 
origins even after very long silent incubation periods. We recently observed the 
direct transmission of a natural classical scrapie isolate to macaque after a 
10-year silent incubation period, with features similar to some reported for 
human cases of sporadic CJD, albeit requiring fourfold longe incubation than 
BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014), is the third 
potentially zoonotic PD (with BSE and L-type BSE), ***thus questioning the 
origin of human sporadic cases. We will present an updated panorama of our 
different transmission studies and discuss the implications of such extended 
incubation periods on risk assessment of animal PD for human health.
===============
*** Scrapie, as recently evoked in humanized mice (Cassard, 2014), is the 
third potentially zoonotic PD (with BSE and L-type BSE), ***thus questioning the 
origin of human sporadic cases.
=============== 
*** LATE-BREAKING ABSTRACTS PRION 2015 CONFERENCE *** 
O18
Zoonotic Potential of CWD Prions
Liuting Qing1, Ignazio Cali1,2, Jue Yuan1, Shenghai Huang3, Diane Kofskey1, 
Pierluigi Gambetti1, Wenquan Zou1, Qingzhong Kong1 1Case Western Reserve 
University, Cleveland, Ohio, USA, 2Second University of Naples, Naples, Italy, 
3Encore Health Resources, Houston, Texas, USA
Chronic wasting disease (CWD) is a widespread and expanding prion disease 
in free-ranging and captive cervid species in North America. The zoonotic 
potential of CWD prions is a serious public health concern. Current literature 
generated with in vitro methods and in vivo animal models (transgenic mice, 
macaques and squirrel monkeys) reports conflicting results. The susceptibility 
of human CNS and peripheral organs to CWD prions remains largely unresolved. In 
our earlier bioassay experiments using several humanized transgenic mouse lines, 
we detected protease-resistant PrPSc in the spleen of two out of 140 mice that 
were intracerebrally inoculated with natural CWD isolates, but PrPSc was not 
detected in the brain of the same mice. Secondary passages with such 
PrPSc-positive CWD-inoculated humanized mouse spleen tissues led to efficient 
prion transmission with clear clinical and pathological signs in both humanized 
and cervidized transgenic mice. Furthermore, a recent bioassay with natural CWD 
isolates in a new humanized transgenic mouse line led to clinical prion 
infection in 2 out of 20 mice. ***These results indicate that the CWD prion has 
the potential to infect human CNS and peripheral lymphoid tissues and that there 
might be asymptomatic human carriers of CWD infection. 
================== 
***These results indicate that the CWD prion has the potential to infect 
human CNS and peripheral lymphoid tissues and that there might be asymptomatic 
human carriers of CWD infection.*** 
================== 
Saturday, May 30, 2015 
PRION 2015 ORAL AND POSTER CONGRESSIONAL ABSTRACTS 
Transmission of scrapie prions to primate after an extended silent 
incubation period 
Emmanuel E. Comoy1 , Jacqueline Mikol1 , Sophie Luccantoni-Freire1 , 
Evelyne Correia1 , Nathalie Lescoutra-Etchegaray1 , Valérie Durand1 , Capucine 
Dehen1 , Olivier Andreoletti2 , Cristina Casalone3 , Juergen A. Richt4 n1 , 
Justin J. Greenlee4 , Thierry Baron5 , Sylvie L. Benestad6 , Paul Brown1 […] 
& Jean-Philippe Deslys1 - Show fewer authors Scientific Reports 5, Article 
number: 11573 (2015) doi:10.1038/srep11573 Download Citation 
Epidemiology | Neurological manifestations | Prion diseases Received: 16 
February 2015 Accepted: 28 May 2015 Published online: 30 June 2015 ABSTRACT 
Classical bovine spongiform encephalopathy (c-BSE) is the only animal prion 
disease reputed to be zoonotic, causing variant Creutzfeldt-Jakob disease (vCJD) 
in humans and having guided protective measures for animal and human health 
against animal prion diseases. Recently, partial transmissions to humanized mice 
showed that the zoonotic potential of scrapie might be similar to c-BSE. We here 
report the direct transmission of a natural classical scrapie isolate to 
cynomolgus macaque, a highly relevant model for human prion diseases, after a 
10-year silent incubation period, with features similar to those reported for 
human cases of sporadic CJD. Scrapie is thus actually transmissible to primates 
with incubation periods compatible with their life expectancy, although fourfold 
longer than BSE. Long-term experimental transmission studies are necessary to 
better assess the zoonotic potential of other prion diseases with high 
prevalence, notably Chronic Wasting Disease of deer and elk and atypical/Nor98 
scrapie. 
snip... 
Discussion 
We describe the transmission of spongiform encephalopathy in a non-human 
primate inoculated 10 years earlier with a strain of sheep c-scrapie. Because of 
this extended incubation period in a facility in which other prion diseases are 
under study, we are obliged to consider two alternative possibilities that might 
explain its occurrence. We first considered the possibility of a sporadic origin 
(like CJD in humans). Such an event is extremely improbable because the 
inoculated animal was 14 years old when the clinical signs appeared, i.e. about 
40% through the expected natural lifetime of this species, compared to a peak 
age incidence of 60–65 years in human sporadic CJD, or about 80% through their 
expected lifetimes. Moreover, sporadic disease has never been observed in 
breeding colonies or primate research laboratories, most notably among hundreds 
of animals over several decades of study at the National Institutes of Health25, 
and in nearly twenty older animals continuously housed in our own 
facility.
The second possibility is a laboratory cross-contamination. Three facts 
make this possibility equally unlikely. First, handling of specimens in our 
laboratory is performed with fastidious attention to the avoidance of any such 
cross-contamination. Second, no laboratory cross-contamination has ever been 
documented in other primate laboratories, including the NIH, even between 
infected and uninfected animals housed in the same or adjacent cages with daily 
intimate contact (P. Brown, personal communication). Third, the cerebral lesion 
profile is different from all the other prion diseases we have studied in this 
model19, with a correlation between cerebellar lesions (massive spongiform 
change of Purkinje cells, intense PrPres staining and reactive gliosis26) and 
ataxia. The iron deposits present in the globus pallidus are a non specific 
finding that have been reported previously in neurodegenerative diseases and 
aging27. Conversely, the thalamic lesion was reminiscent of a metabolic disease 
due to thiamine deficiency28 but blood thiamine levels were within normal limits 
(data not shown). The preferential distribution of spongiform change in cortex 
associated with a limited distribution in the brainstem is reminiscent of the 
lesion profile in MM2c and VV1 sCJD patients29, but interspecies comparison of 
lesion profiles should be interpreted with caution. It is of note that the same 
classical scrapie isolate induced TSE in C57Bl/6 mice with similar incubation 
periods and lesional profiles as a sample derived from a MM1 sCJD 
patient30.
We are therefore confident that the illness in this cynomolgus macaque 
represents a true transmission of a sheep c-scrapie isolate directly to an 
old-world monkey, which taxonomically resides in the primate subdivision 
(parvorder of catarrhini) that includes humans. With an homology of its PrP 
protein with humans of 96.4%31, cynomolgus macaque constitutes a highly relevant 
model for assessing zoonotic risk of prion diseases. Since our initial aim was 
to show the absence of transmission of scrapie to macaques in the worst-case 
scenario, we obtained materials from a flock of naturally-infected sheep, 
affecting animals with different genotypes32. This c-scrapie isolate exhibited 
complete transmission in ARQ/ARQ sheep (332 ± 56 days) and Tg338 transgenic mice 
expressing ovine VRQ/VRQ prion protein (220 ± 5 days) (O. Andreoletti, personal 
communication). From the standpoint of zoonotic risk, it is important to note 
that sheep with c-scrapie (including the isolate used in our study) have 
demonstrable infectivity throughout their lymphoreticular system early in the 
incubation period of the disease (3 months-old for all the lymphoid organs, and 
as early as 2 months-old in gut-associated lymph nodes)33. In addition, scrapie 
infectivity has been identified in blood34, milk35 and skeletal muscle36 from 
asymptomatic but scrapie infected small ruminants which implies a potential 
dietary exposure for consumers.
Two earlier studies have reported the occurrence of clinical TSE in 
cynomolgus macaques after exposures to scrapie isolates. In the first study, the 
“Compton” scrapie isolate (derived from an English sheep) and serially 
propagated for 9 passages in goats did not transmit TSE in cynomolgus macaque, 
rhesus macaque or chimpanzee within 7 years following intracerebral challenge1; 
conversely, after 8 supplementary passages in conventional mice, this “Compton” 
isolate induced TSE in a cynomolgus macaque 5 years after intracerebral 
challenge, but rhesus macaques and chimpanzee remained asymptomatic 8.5 years 
post-exposure8. However, multiple successive passages that are classically used 
to select laboratory-adapted prion strains can significantly modify the initial 
properties of a scrapie isolate, thus questioning the relevance of zoonotic 
potential for the initial sheep-derived isolate. The same isolate had also 
induced disease into squirrel monkeys (new-world monkey)9. A second historical 
observation reported that a cynomolgus macaque developed TSE 6 years 
post-inoculation with brain homogenate from a scrapie-infected Suffolk ewe 
(derived from USA), whereas a rhesus macaque and a chimpanzee exposed to the 
same inoculum remained healthy 9 years post-exposure1. This inoculum also 
induced TSE in squirrel monkeys after 4 passages in mice. Other scrapie 
transmission attempts in macaque failed but had more shorter periods of 
observation in comparison to the current study. Further, it is possible that 
there are differences in the zoonotic potential of different scrapie 
strains.
The most striking observation in our study is the extended incubation 
period of scrapie in the macaque model, which has several implications. Firstly, 
our observations constitute experimental evidence in favor of the zoonotic 
potential of c-scrapie, at least for this isolate that has been extensively 
studied32,33,34,35,36. The cross-species zoonotic ability of this isolate should 
be confirmed by performing duplicate intracerebral exposures and assessing the 
transmissibility by the oral route (a successful transmission of prion strains 
through the intracerebral route may not necessarily indicate the potential for 
oral transmission37). However, such confirmatory experiments may require more 
than one decade, which is hardly compatible with current general management and 
support of scientific projects; thus this study should be rather considered as a 
case report.
Secondly, transmission of c-BSE to primates occurred within 8 years post 
exposure for the lowest doses able to transmit the disease (the survival period 
after inoculation is inversely proportional to the initial amount of infectious 
inoculum). The occurrence of scrapie 10 years after exposure to a high dose (25 
mg) of scrapie-infected sheep brain suggests that the macaque has a higher 
species barrier for sheep c-scrapie than c-BSE, although it is notable that 
previous studies based on in vitro conversion of PrP suggested that BSE and 
scrapie prions would have a similar conversion potential for human PrP38.
Thirdly, prion diseases typically have longer incubation periods after oral 
exposure than after intracerebral inoculations: since humans can develop Kuru 47 
years after oral exposure39, an incubation time of several decades after oral 
exposure to scrapie would therefore be expected, leading the disease to occur in 
older adults, i.e. the peak age for cases considered to be sporadic disease, and 
making a distinction between scrapie-associated and truly sporadic disease 
extremely difficult to appreciate.
Fourthly, epidemiologic evidence is necessary to confirm the zoonotic 
potential of an animal disease suggested by experimental studies. A relatively 
short incubation period and a peculiar epidemiological situation (e.g., all the 
first vCJD cases occurring in the country with the most important ongoing c-BSE 
epizootic) led to a high degree of suspicion that c-BSE was the cause of vCJD. 
Sporadic CJD are considered spontaneous diseases with an almost stable and 
constant worldwide prevalence (0.5–2 cases per million inhabitants per year), 
and previous epidemiological studies were unable to draw a link between sCJD and 
classical scrapie6,7,40,41, even though external causes were hypothesized to 
explain the occurrence of some sCJD clusters42,43,44. However, extended 
incubation periods exceeding several decades would impair the predictive values 
of epidemiological surveillance for prion diseases, already weakened by a 
limited prevalence of prion diseases and the multiplicity of isolates gathered 
under the phenotypes of “scrapie” and “sporadic CJD”.
Fifthly, considering this 10 year-long incubation period, together with 
both laboratory and epidemiological evidence of decade or longer intervals 
between infection and clinical onset of disease, no premature conclusions should 
be drawn from negative transmission studies in cynomolgus macaques with less 
than a decade of observation, as in the aforementioned historical transmission 
studies of scrapie to primates1,8,9. Our observations and those of others45,46 
to date are unable to provide definitive evidence regarding the zoonotic 
potential of CWD, atypical/Nor98 scrapie or H-type BSE. The extended incubation 
period of the scrapie-affected macaque in the current study also underscores the 
limitations of rodent models expressing human PrP for assessing the zoonotic 
potential of some prion diseases since their lifespan remains limited to 
approximately two years21,47,48. This point is illustrated by the fact that the 
recently reported transmission of scrapie to humanized mice was not associated 
with clinical signs for up to 750 days and occurred in an extreme minority of 
mice with only a marginal increase in attack rate upon second passage13. The low 
attack rate in these studies is certainly linked to the limited lifespan of mice 
compared to the very long periods of observation necessary to demonstrate the 
development of scrapie. Alternatively, one could estimate that a successful 
second passage is the result of strain adaptation to the species barrier, thus 
poorly relevant of the real zoonotic potential of the original scrapie isolate 
of sheep origin49. The development of scrapie in this primate after an 
incubation period compatible with its lifespan complements the study conducted 
in transgenic (humanized) mice; taken together these studies suggest that some 
isolates of sheep scrapie can promote misfolding of the human prion protein and 
that scrapie can develop within the lifespan of some primate species.
In addition to previous studies on scrapie transmission to primate1,8,9 and 
the recently published study on transgenic humanized mice13, our results 
constitute new evidence for recommending that the potential risk of scrapie for 
human health should not be dismissed. Indeed, human PrP transgenic mice and 
primates are the most relevant models for investigating the human transmission 
barrier. To what extent such models are informative for measuring the zoonotic 
potential of an animal TSE under field exposure conditions is unknown. During 
the past decades, many protective measures have been successfully implemented to 
protect cattle from the spread of c-BSE, and some of these measures have been 
extended to sheep and goats to protect from scrapie according to the principle 
of precaution. Since cases of c-BSE have greatly reduced in number, those 
protective measures are currently being challenged and relaxed in the absence of 
other known zoonotic animal prion disease. We recommend that risk managers 
should be aware of the long term potential risk to human health of at least 
certain scrapie isolates, notably for lymphotropic strains like the classical 
scrapie strain used in the current study. Relatively high amounts of infectivity 
in peripheral lymphoid organs in animals infected with these strains could lead 
to contamination of food products produced for human consumption. Efforts should 
also be maintained to further assess the zoonotic potential of other animal 
prion strains in long-term studies, notably lymphotropic strains with high 
prevalence like CWD, which is spreading across North America, and atypical/Nor98 
scrapie (Nor98)50 that was first detected in the past two decades and now 
represents approximately half of all reported cases of prion diseases in small 
ruminants worldwide, including territories previously considered as scrapie 
free. Even if the prevailing view is that sporadic CJD is due to the spontaneous 
formation of CJD prions, it remains possible that its apparent sporadic nature 
may, at least in part, result from our limited capacity to identify an 
environmental origin. 
Thursday, July 24, 2014 
*** Protocol for further laboratory investigations into the distribution of 
infectivity of Atypical BSE SCIENTIFIC REPORT OF EFSA New protocol for Atypical 
BSE investigations 
Saturday, March 21, 2015 
Canada and United States Creutzfeldt Jakob TSE Prion Disease Incidence 
Rates Increasing 
Terry S. Singeltary S. 
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