Download Quality Assurance of Veterinary Reagents (ELISA and Real

Quality Assurance of Veterinary Reagents
(ELISA and Real-time PCR) for Diagnostic
Laboratories
Yves Van der Stede
CODA-CERVA
Operational Directorate « Interactions and Surveillance »
Operational Unit “Coordination of veterinary diagnosis - epidemiology and risk assessment”
The free movement of animals and animal products does without any doubt have effects on animal health.
Veterinary diagnostic laboratories play a very important part when it comes to animal health surveillance. One of
the most obvious aspects within this context is the demand for high-performance and high-quality commercial
veterinary diagnostic reagents. The laboratory of the Coordination of Veterinary Diagnosis-Epidemiology and Risk
Assessment (CDD-ERA) section of the CODA-CERVA (Veterinary and Agrochemical Research Centre) has been
ordered by the Federal Agency for the Safety of the Food Chain (FASFC) to perform the quality control of the veterinary reagents (ELISA and Real time PCR kits) used in official disease control programmes, e.g. those for Infectious
Bovine Rhinotracheitis (IBR), Brucellosis and Leucosis in bovine animals and Aujeszky disease in swine.
The quality control of these veterinary reagents depends on the proficiency of the laboratory and the reliability
of the test results obtained for this control. The quality of these results can be guaranteed by laying down and
implementing procedures within an ISO 17025 compliant quality system.
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Quality Control of Veterinary Reagents (ELISA and real time PCR) at the
CODA-CERVA:
Before being authorized to market certain veterinary reagents intended for one specific animal disease in Belgium,
the manufacturer must take part in and pass an initial control, the aim of which is to test the veterinary reagents in
question against the minimum criteria established beforehand by the CDD-ERA section and the National Reference Laboratory of CODA-CERVA. Some of these criteria are of an administrative nature. The manufacturers will be
asked to submit the necessary data on the diagnostic reagents by means of standardized documents and checklists (in accordance with OIE and AFNOR instructions (NF U47-301)). These data relate e.g. to the scope of the test
(= what is the test for ?), the full validation file including the essential parameters such as the sensitivity and the
specificity of the test, repeatability and reproducibility of the tests, the composition of the product, the test protocol, the in-house quality system and the criteria to be met by the test. In addition, they will be asked to submit
epidemiological studies and reports of proficiency tests which illustrate the use and the accuracy of the reagents
under evaluation. When these administrative criteria are met, the manufacturer will be invited to send one specific
batch of his reagents to CODA-CERVA for testing against the pre-established minimum technical criteria. These
criteria relate to the scope of the test as well as to analytical and diagnostic sensitivity and specificity, repeatability
and reproducibility. The reagents of a manufacturer can only be admitted to the Belgian market when they have
passed the test for both the administrative and the technical criteria. The list of authorized veterinary reagents
per manufacturer, animal disease, matrix and protocol is available on the website of the FASFC. Afterwards, each
manufacturer has to have each batch of veterinary reagents which might be offered to approved Belgian diagnostic veterinary laboratories tested for quality by the CDD-ERA section of CODA-CERVA. This batch control is performed in accordance with a valid SOP and always consists of testing the same quality criteria (sensitivity, specificity,
repeatability and reproducibility, detection limit) using a set of well characterized samples. A certificate shall be
drawn up for each batch that was approved and sent to the end-users, i.e. diagnostic laboratories that use these
reagents to perform tests within the scope of official animal disease control, under the authority of the FASFC. The
end-users also give feedback on the practical use of the reagents to the CDD-ERA section of CODA-CERVA, with
regard to their quality. By taking part in proficiency tests set up by CODA-CERVA in accordance with ISO 17043,
the quality of the end-users as well as the veterinary reagents and their manufacturers is assessed year after year.
When the tests reveal that some reagents/manufacturers cause too many problems, they may be removed from
the list.
Conclusion:
Thanks to the quality control of veterinary reagents performed by the CDD-ERA section of CODA-CERVA, an
unequivocal and standardized control can be performed and maintained with respect to diagnostics within the
context of official animal disease control. This control guarantees the quality of the test results reported by the
approved Belgian veterinary diagnostic laboratories, which therefore improves animal health and, undoubtedly,
stimulates the international animal and animal products trade.
[email protected]
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