B-Brussels: call for expression of interest to participate in a programme
for the evaluation of tests for the diagnosis of transmissible spongiform
encephalopathies (TSE) in ruminants
2007/S 204-247339
1. Organising authority: European Commission, Directorate-General Health
and Consumer Protection (DG SANCO).
2. Selection procedure: Open call for the expression of interest, open
worldwide.
3. Summary description: The European Commission (EC) completed the first
evaluation of rapid diagnostic tests for TSE in cattle in 1999. Further
evaluations of rapid diagnostic tests for TSE in ruminants (cattle and small
ruminants) were carried out and finalised since then.
The Commission is aware that developmental work on other tests has continued
and now wishes to launch a new evaluation programme to continue the
determination of the capability of such tests.
The objectives of the call are the identification and the selection of new
tests that may be suitable to include in a programme for evaluation of tests
for the diagnosis of TSE in ruminants.
The tests selected for evaluation will be tests considered to be capable to
provide reliable evidence on the presence of TSE agents in ruminants, and
which demonstrate excellent performance.
The evaluation programme is limited to tests that are sufficiently well
developed to market after approval, and which can be shown to offer
potential on the basis of a previous evaluation work carried out by or on
behalf of the developer. Priority of evaluation will be given to tests which
can demonstrate high sensitivity, high specificity and low limits of
detection.
Research laboratories or private or public institutions that claim to have
such a test are invited to express their interest and to submit a technical
dossier supporting their claim.
4. General conditions and detailed specifications: Each application will
undergo an assessment process and tests may be selected for inclusion into
an evaluation programme on the basis of specific criteria listed in the
Annex to the present call.
5. Submission for the expression of interest and technical dossier: (a)
Postal address:
European Commission, Directorate-General Health and Consumer Protection (DG
SANCO), Directorate E — Unit E2, Rue Belliard 232, B-1049 Bruxelles/Brussel.
(b) 3 copies of the documentation, written in 1 of the official languages of
the European Union, should be submitted.
(c) Deadline for submission: see point 6.
6. Validity of the call: This call for expression of interest will remain
open for 5 years from the date of its publication. The expression of
interest and the submitted dossiers will only be considered if sent to the
Commission between 1 December and 1 March of the following year (date as
confirmed by postmark). Any dossiers arriving outside this period will not
be considered and will have to be resubmitted by the applicants during the
next target period.
7. Costs: Applicants whose test has been selected for entry into the
evaluation programme will be charged before the beginning of the programme.
Those charges will be levied by the Joint Research Centre of European
Commission – Institute for Reference Materials and Measurements (JRC-IRMM)
and are intended to cover technical and administrative costs associated with
each stage of the evaluation programme (pre-evaluation step, dispatch of the
standardised evaluation samples, full laboratory evaluation and field trial,
data evaluation and reporting). Applicants will be expected to cover costs
associated with the evaluation up to a maximum amount of EUR 90 000 per
submitted test for post mortem tests. For ante mortem tests, costs will be
assessed on a case by case basis, pending availability of suitable samples
and feasibility of logistics. A bank guarantee up to the aforementioned
amount shall be provided by the applicants when submitting their technical
dossier for post mortem tests.
8. Date of dispatch of the notice: 11.10.2007.
9. Date of receipt of the OOPEC: 11.10.2007.
10. No prior information has been published in respect of this call for
expression of interest.
Annex
1. Objectives of the call:
The European Commission (EC) completed the first evaluation of rapid
diagnostic tests for transmissible spongiform encephalopathies (TSE) in
cattle in 1999. Further evaluations of rapid diagnostic tests for TSE in
ruminants (cattle and small ruminants) have subsequently been carried out.
The EC is aware that developmental work on other tests has continued and now
launches a new open call for expression of interest intended to cover tests
for the detection of TSE in large (cattle) and small (sheep and goats)
ruminants.
The objectives of the present call are to identify new tests and to select
those that are suitable for inclusion in an evaluation programme. The tests
selected for evaluation will be tests considered to be capable of detecting
TSE in ruminants and which demonstrate excellent performance.
2. Submission of the expression of interest:
Research laboratories, private or public institutions that have a test they
wish to be considered for inclusion in an evaluation programme, are invited
to express their interest and to submit a technical dossier in accordance
with the specific requirements set out hereafter.
2.1 Content of application:
The application must at least include:
a technical dossier presenting the information requested in point 2.3;
a statement declaring that:
— the development of the proposed test is sufficiently advanced to be
evaluated under field conditions and on a large number of samples and no
additional research is still required,
— the test has the capacity of being commercialised in its proposed format,
— if some biological material is provided for testing purposes by the
Commission services, the applicant is fully compliant with the appropriate
national provisions relating to the handling and destruction of TSE-infected
material and duly authorised by the competent authorities to work with such
material,
— if the test is approved by the EC, the applicant agrees to license the
test to third parties, respecting a non-discriminatory policy in making the
test available.
2.2 Administrative aspects:
The expression of interest may be submitted by any natural or legal person,
public or private body established within the territory of the European
Union (EU) or in any third country. By submitting an expression of interest
the applicant implicitly agrees to the terms and conditions to which this
refers. The documentation must be submitted in one of the official languages
of the EU. A summary in English will be helpful.
3 unbound copies of the submissions must be enclosed in a double sealed
package bearing the applicant's name (on both outer and inner package), and
sent to the following postal address:
European Commission, Directorate-General Health and Consumer Protection (DG
SANCO), Directorate E — Unit E2, Rue Belliard 232, B-1049 Bruxelles/Brussel.
The following mention must be labelled on both the outer and the inner
package:
'Commercial in confidence, TSE tests evaluation programme, Call for
expression of interest'.
2.3 Technical information to provide:
The technical dossier shall at least include the following information:
— scientific basis and principles of the proposed test, including details of
antibodies, epitopes and all reagents used. For ante mortem tests, the
applicant shall provide sufficient information on the test to demonstrate
that proof of principle has been established,
— detailed specification of the samples that can be tested (central nervous
system (CNS) only or specific parts thereof or other tissues and fluids),
acceptable physical form (whole or homogenised material),
— details of all initial evaluation work carried out on the test, species
and tissues used, number of animals/samples tested, results obtained and
basis of validation of the results. Minimum requirements concerning this
initial evaluation work are laid down in the EFSA opinions referred to in
point 5,
— repeatability data (same samples tested multiple times within and between
assays),
— reproducibility of results within and between antibody batches,
— stage of the incubation period at which the test is considered effective,
— expected diagnostic sensitivity and specificity under field conditions,
— any known or expected limitations of the test,
— laboratory protocols and procedures, equipment and reagents required,
personnel, level of standardisation of the equipment and products used and
their availability on the market, duration of the test (references,
definitions and a schematic representation of the procedure would be
helpful),
— quality systems in place either for the test, or at least for other
company products, so as to demonstrate that a minimum of delay can be
expected in establishing such a system for the test prior to marketing,
— details of the sampling procedure in the field with evaluation of
practicality and required level of training of operators,
— estimated time from sampling until results are available,
— degree of test automation (actual or potential),
— expected independence and objectivity of the results (degree of
independence from human interpretation; non-ambiguity of the results);
— transferability to other laboratories and expected variability of the
results, if carried out in different laboratories,
— likely cost of the test if in commercial use. Cost estimations per test
shall be provided, taking into account likely test-kit costs, other
reagents, equipment, and technical staff time.
It is accepted that certain details of testing protocols or methods may be
confidential. Confidential information shall be clearly indicated as such on
all occasions that such information is mentioned. It is not sufficient to
simply state that all details are confidential.
3. Selection procedure of tests to be included in an evaluation programme:
Each submitted dossier will be evaluated by a panel of TSE independent
experts managed by the European Food Safety Authority (EFSA).
The tests to be considered for inclusion in the evaluation programme will be
selected on the basis of the following criteria:
— the soundness of the underlying scientific principles,
— experimental evidence of the capability of the test to distinguish between
TSE-free and infected animals. Priority will be given to tests which
demonstrate excellent diagnostic sensitivity and diagnostic specificity
based upon inclusion of significant testing data in the technical dossier,
— practicality of the sampling and testing procedure,
— availability of the test for immediate evaluation,
— prospects and expected time needed for possible commercial use of the test
if it were successfully evaluated,
— quality system of manufacturer,
— ability of the test to detect the current proficiency test panels issues
by the TSE Community Reference Laboratory (CRL) if CNS is a target tissue
for the test,
— potential for transferability of the test to other laboratories,
— the expected unit cost of the test, once operational and commercialised.
Specific criteria that will be used for the assessment of the submitted
dossiers can be found in the EFSA opinions referred to in point 5.
Applicants will be informed of the results of the selection as soon as they
are known.
4. Evaluation programme
4.1 Description of the programme for post mortem tests:
Applicants with post mortem tests selected according to the above-mentioned
selection procedure will be invited to submit their test to an evaluation
programme.
This programme will comprise several stages:
— a pre-evaluation step including a visit to the manufacturer's premises to
see the test being performed, to inspect the kit production and quality
control facilities. During the visit, the manufacturer will be required to
test a typical panel of proficiency test samples, including a panel of
dilution series,
— a full laboratory evaluation supervised by the Joint Research Centre of
European Commission — Institute for Reference Materials and Measurements
(JRC-IRMM). During this step, the proposed tests will be assessed using
reference tissues with a known TSE status. The JRC-IRMM will be responsible
for provision of suitable samples to applicants, coordination of test
evaluation and assessment of results,
— a field trial (for cattle) or a report comprising raw data from 10 000
negative samples from at least 2 testing laboratories (for small ruminants)
aiming to assess the quality of the proposed tests under field conditions.
Each stage is compulsory within the evaluation programme and will be
assessed by a panel of independent TSE experts supervised by the EFSA (EFSA
working group on TSE testing). Progress to the next stage requires
successful completion of the previous stage and therefore the process can be
suspended at any stage of the evaluation. Specific criteria that must be
complied with for passing the evaluation can be found in the EFSA opinions
referred to in point 5.
Recommendations to the EC concerning the suitability to approve or not the
submitted tests will be issued by EFSA. Those recommendations will be based
on the results of the evaluation process.
4.2 Description of the programme for ante mortem tests:
Since evaluation of ante mortem tests presents significant challenges that
require development of analyte-specific approaches, it is not possible to
define a general evaluation approach that will suit all ante mortem tests
equally. Successfully selected tests will therefore be subjected to a
specific evaluation programme that will be dependent on test analytes and
availability of appropriate validation materials.
All the results of the evaluation programme will be assessed by a panel of
independent TSE experts supervised by the EFSA (EFSA working group on TSE
testing). After the completion of this evaluation, recommendations to the EC
concerning the suitability to approve or not the submitted tests will be
issued by EFSA.
5. EFSA opinions:
Specific conditions and criteria related to the information to be present in
the dossier, the assessment of the dossier and the evaluation programme are
laid down in the 3 following opinions of the Biohazards Panel of the EFSA:
— Scientific Opinion of the Panel on Biological Hazards on a request from
the European Commission on a protocol for the evaluation of new rapid BSE
post mortem tests. The EFSA Journal (2007) 508, 1–20
(http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178621164635.htm)
,
— Scientific Opinion of the Panel on Biological Hazards on a request from
the European Commission on a protocol for the evaluation of rapid post
mortem tests to detect TSE in small ruminants. The EFSA Journal (2007) 509,
1–31
(http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178621164181.htm)
,
— Scientific Opinion of the Panel on Biological Hazards on a request from
the European Commission on Protocol for a preliminary evaluation of ante
mortem TSE tests for ruminants. The EFSA Journal (2007) 540, 1–12
(http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178647203021.htm)
.
Questions related to the content of the opinions should be directly
addressed to the secretariat of the Biohazards Panel of EFSA.
http://ted.europa.eu/Exec;jsessionid=F4F648DE61CC4F84EEFCD9F5A0264931.instance_2?DataFlow=ShowPage.dfl&Template=TED/N_one_result_detail_curr.htm&docnumber=247339-2007&docId=247339-2007&StatLang=EN
BSE BASE MAD COW TESTING TEXAS, USA, AND CANADA, A REVIEW OF SORTS
http://madcowtesting.blogspot.com/
PLEASE NOTE IN USA CJD UPDATE AS AT JUNE 2007, please note steady increase
in ''TYPE UNKNOWN''. ...TSS
1 Acquired in the United Kingdom; 2 Acquired in Saudi Arabia; 3 Includes 17
inconclusive and 9 pending (1 from 2006, 8
from 2007); 4 Includes 17 non-vCJD type unknown (2 from 1996, 2 from 1997, 1
from 2001, 1 from 2003, 4 from 2004, 3
from 2005, 4 from 2006) and 36 type pending (2 from 2005, 8 from 2006, ***
26 from 2007)
http://www.cjdsurveillance.com/pdf/case-table.pdf
CREUTZFELDT JAKOB DISEASE MAD COW BASE, CWD, SCRAPIE UPDATE OCT 2007
http://cjdmadcowbaseoct2007.blogspot.com/
NOR-98 ATYPICAL SCRAPIE USA UPDATE AS AT OCT 2007
Tuesday, October 9, 2007
NOR-98 SCRAPIE UPDATE AUGUST 31, 2007 RISES TO 5 DOCUMENTED CASES
http://nor-98.blogspot.com/
ABSTRACTS SPORADIC CJD AND H BASE MAD COW ALABAMA AND TEXAS SEPTEMBER 2007
Date: Mon, 24 Sep 2007 21:31:55 -0500
I suggest that you all read the data out about h-BASE and sporadic CJD, GSS,
blood, and some of the other abstracts from the PRION2007. ...
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0709&L=sanet-mg&T=0&F=&S=&P=19744
*** PLEASE READ AND UNDERSTAND THE RAMIFICATIONS OF THIS !!! THE PRICE OF
POKER INDEED GOES UP. ...TSS
USA BASE CASE, (ATYPICAL BSE), AND OR TSE (whatever they are calling it
today), please note that both the ALABAMA COW, AND THE TEXAS COW, both were
''H-TYPE'', personal communication Detwiler et al Wednesday, August 22, 2007
11:52 PM. ...TSS
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0708&L=sanet-mg&T=0&P=19779
From: "Terry S. Singeltary Sr."
Subject: CWD UPDATE 88 AUGUST 31, 2007
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0709&L=sanet-mg&T=0&P=450
TSS