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Genetic Analysis WG
ICAR rules and guidelines for accreditation of DNA
paternity testing in cattle
Considered the need for
defined high quality standards in bovine
paternity testing due to the relevant impact
that wrong parentage may have in the estimation
of genetic indexes and in national and
international genetic evaluations and based on
the two year work of the genetic analysis
task force, ICAR has decided to define minimum
requirements for laboratories running DNA
analyses for breeding purposes. Guidelines for
accreditation are presently given for paternity
testing in cattle based on microsatellite
analyses. Minimum requirements for additional
species and DNA tests will be defined in the
near future.
Laboratories requesting accreditation will have to
apply for it downloading and filling a questionnaire
(Annex I) that will be made available on the ICAR
website. The form is to be filled accurately,
providing necessary documentation, when required.
Accreditation will be released for a two-year
period, at the end of which a new application is to
be completed and submitted. The application will be
evaluated by a Committee of Experts appointed
by ICAR that will approve it, require additional
information or reject it. In case of rejection the
applicant may submit a new form at least one year
after her/his failed application.
The
present Rules contain Minimum requirements
for accreditation of DNA paternity testing in
cattle.
Annexes I, II and III in the
hard copy will contain the guidelines for the
implementation of these Rules.
1)
LABORATORY IDENTIFICATION
The applicant should be
unambiguously identified:
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Name of the laboratory.
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Institution if relevant.
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Address and Country.
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A reference person as well as all information
necessary for quickly getting in touch with her/him
is to be given.
2)
EDUCATION AND TRAINING OF LAB SUPERVISOR AND
OPERATORS
The minimum requirements for
education and training of laboratory supervisor and
operators are:
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At least a bachelor degree in a
scientific discipline is required to the laboratory
head or supervisor.
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At least 5 years experience in molecular
diagnostics is required to the laboratory senior
operator.
Experience is considered a key
factor both in data production and in the
interpretation of results.
3)
EQUIPMENT
-
Equipment used to run and score
microsatellite is to be described.
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The year of purchase and last revision is to
be made available, to check the appropriateness of
technologies used and the following of a proper
maintenance program ensuring the production of high
quality data.
-
Yearly revision is considered as a minimum
requirement.
-
A personal opinion on the performance of the
laboratory set up available is asked to foresee the
need for improvements in quality standards.
4)
CERTIFICATION
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International or national certification
should be declared.
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International certification will become a
minimum requirement for ICAR accreditation within 3
years after the approval of these Rules.
5)
PARTICIPATION AND PERFORMANCE IN RING TEST
-
The participation to international and
national ring test is to be declared and the
performance in these ring tests disclosed.
-
The
participation in at least two international ring
tests is considered a minimum requirement.
The Committee of Experts,
considering the structure of the ring test and the
average performance of laboratories in the ring test
and year, will decide performance thresholds.
Indications on how to calculate error rate are given
in Annex II.
6)
MICROSATELLITE MARKERS
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Name of all microsatellites typed on all
animals (marker set I) and of the additional ones
assayed in the case of unresolved paternity (marker
set II) is to be declared, as well as the number of
animals typed in the last two years.
-
Minimum requirement is the use on all animals
typed of the complete set of 9 micorsatellites
recommended by ISAG (see Annex III).
-
The upgrade of the number of markers assayed
on all animals to a minimum of 11 is envisaged in
the short period, with the perspective of increasing
this minimum requirement to the use of 16
microsatellites.
-
d)
To ensure sufficient experience within the
lab, a number of 500 animals analysed per year is
set as minimum requirement for certification.
-
Exclusion probability (2 parents and 1
parent) of each and every marker and of complete
marker sets is to be calculated and declared.
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The type of population and the number of
animals used for computations are to be described.
ICAR recommends using Holstein as reference when
possible. The ICAR Committee of Experts will
evaluate that an appropriate PE is reached for
accreditation, on the basis of the population
analyzed.
7)
MARKER NOMENCLATURE
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Nomenclature of markers is to be described.
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Minimum requirement is the use of ISAG
nomenclature at least for the ISAG marker set.
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been visited
since 9-March-2007
Page last up-dated:
12/07/2008
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