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Initial control procedure | open calls

Last updated on 1-6-2022 by Simon Van den bergh

Sciensano controls the quality of diagnostic reagents used within official animal disease programs commissioned by the Federal Agency for the Safety of the Food Chain (FASFC). In this scope, we regularly launch calls for the Initial Control of commercial diagnostic reagents (such as ELISA or PCR kits) for the detection of specific antibodies or antigens. Diagnostic reagents that passed the two phases of the certification procedure, are allowed on the Belgian market in the framework of official programs.

 

Please note that in order to request certification of a diagnostic kit for a pathogen that is already part of an animal disease surveillance/control program, manufacturers or distributors do not need to wait for an open call. They may request such a supplementary initial certification procedure at any time (see “How to participate in an initial control procedure”).

Open calls

Recognition of Certification of ELISA kits for total IBR antibodies and gB antibodies (milk matrix)

Suppl_ Cert_ IBRgB_AbELISA_MILK_2017_2024_16204

Announcement: Monday, April 22, 2024

In the frame of the Belgian official programs for animal disease control, Sciensano in consultation with the Federal Agency for the Safety of the Food Chain (FASFC) calls for candidacy for the recognition of commercial diagnostic reagents: kits for the detection of total or specific gB antibodies to Bovine Infectious Rhinotracheitis Virus (IBR) in bulk tank milk from cattle. This recognition will give access to the Belgian market and the official program. This procedure does not concern any selected tender.

If producers/distributors for these Ab ELISA kits wish to participate for the Belgian market and wish to have a reagent recognized on the List by Monday, July 22, 2024 , they should contact SPOC Diagnostic Control:

Diagnostic.Control@sciensano.be

and comply with the Recognition Criteria, as listed in the attached pdf document, before the Monday, July 22, 2024 - 14:45.

Deadline for add in List recognised kits of : Monday, July 22, 2024
Compliance with Criteria and submission Administrative Dossier and Kit: Monday, July 22, 2024 - 14:45

Participation: Contact SPOC DC: Diagnostic.Control@sciensano.be

Initial Control Procedures since 2010

Initial control Procedure Reference number Type of reagent State
Cert_TUB_IFNgELISA_2021 16207 IFN Gamma Completed
Cert_TUB_AbELISA_serum_2021 16206 Ab ELISA Completed
Cert_TUB_IFNgELISA_2021 16207 IFN Gamma Completed
Cert_TUB_AbELISA_serum_2021 16206 Ab ELISA Completed
Cert_TUB_AbELISA_serum_2021 16206 Ab ELISA Completed
Cert_TUB_IFNgELISA_2021 16207 IFN Gamma Completed
Cert_BRU Ab ELISA tankmilk 2018 16205 Ab ELISA Completed
Cert_BRU Ab ELISA tankmilk 2018 16205 Ab ELISA Completed
SuppCert_IBRgB_2012 PRO/4.3/03 1693 Ab ELISA Completed
Cert_BLT8_2012 PRO/4.3/03 16191 Ab ELISA Completed
Cert_BVDV_2012 PRO/4.3/03 16195 Ag ELISA Completed
SuppCert_IBRgB_2013 PRO/4.3/03 1693 Ab ELISA Completed
SuppCert_BLT8_2013 PRO/4.3/03 16191 Ab ELISA Completed
Rec_BVD_2014 RT-PCR Completed
Cert_IBRgE_2014 PRO/4.3/03 16201 Ab ELISA Completed
Cert_BVDV_2015 PRO/4.3/03 16202 Ab ELISA Completed
Cert_IBRgB_2010 PRO/4.3/03 1693 Ab ELISA Completed
Cert_AUJgB_2011 PRO/4.3/03 16181 Ab ELISA Completed
Cert_QFever_2011 PRO/4.3/03 16190 Ab ELISA Completed
Cert_ IBRgB_AbELISA_MILK_2017 16204 ELISA Completed
Cert_IBR gE_Ab ELISA milk_2017 16203 ELISA Completed

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