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Validation of Diagnostic Reagents : Initial Controls

Opened Initial Controls

 


Recognition of IBR total Ab and gB Ab ELISA milk kits

Cert_IBR gB_Ab ELISA milk_2017_16204

Announcement: Wednesday 25th October 2017

 

In the frame of the Belgian official programs for animal disease control, the CODA-CERVA (Veterinary and Agrochemical Research Centre) in consultation with the Federal Agency for the Safety of the Food Chain (FASFC) calls for candidacy for the recognition of commercial diagnostic reagents: ELISA kits for the detection of total or specific Infectious bovine rhinotracheitis Virus (IBR gB) antibodies in Bovine tank milk. 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 IBR total Ab and gB Ab ELISA milk kits wish to participate for the Belgian market and wish to have a reagent recognized on the List by 25th of October 2018 , they should contact SPOC Diagnostic Control

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and comply with the Recognition Criteria, as listed in the attached pdf document, before the 25th of January 2018.

 

Deadline for add in List recognised kits of 25/10/2018:
Compliance with Criteria and submission Administrative Dossier and Kit:
by Thursday 25th January 2018 at 10am

 

Recognition Criteria IBR total Ab and gB Ab ELISA milk kits:
Ref16204_Minimum_Criteria


Publication Staatsblad/Moniteur: Wednesday the 25th of October 2017
Ref16204_Staatsblad_Moniteur

 


Instructions Cert IBR gB_Ab ELISA milk_2017_16204:
Ref16204_Bulletin



Participation: Contact SPOC DC:

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Recognition of IBR gE Ab ELISA milk kits

Cert_IBR gE_Ab ELISA milk_2017_16203

Announcement: Tuesday 8th September 2015

 

In the frame of the Belgian official programs for animal disease control, the CODA-CERVA (Veterinary and Agrochemical Research Centre) in consultation with the Federal Agency for the Safety of the Food Chain (FASFC) calls for candidacy for the recognition of commercial diagnostic reagents: ELISA kits for the detection of specific Infectious bovine rhinotracheitis Virus (IBR gE) antibodies in Bovine tank milk. 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 IBR gE Ab ELISA milk kits wish to participate for the Belgian market and wish to have a reagent recognized on the List by 25th of October 2018 , they should contact SPOC Diagnostic Control

This e-mail address is being protected from spambots. You need JavaScript enabled to view it


and comply with the Recognition Criteria, as listed in the attached pdf document, before the 25th of January 2018.

 

Deadline for add in List recognised kits of 25/10/2018:
Compliance with Criteria and submission Administrative Dossier and Kit:
by Thursday 25th of January 2018 at 10am

 

Recognition Criteria IBR gE Ab ELISA milk kits:
Ref16203_Minimum_Criteria


Publication Staatsblad/Moniteur: Wednesday the 25th of October 2017
Ref16203_Staatsblad_Moniteur


Instructions Cert IBR gE_Ab ELISA milk_2017_16203:
Ref16203_Bulletin


 

Participation: Contact SPOC DC:

This e-mail address is being protected from spambots. You need JavaScript enabled to view it



In the frame of the official programs for animal disease control, the CODA-CERVA (Veterinary and Agrochemical Research Centre) in consultation with the Federal Agency for the Safety of the Food Chain (FASFC) regularly calls for candidacy for the Initial Control of commercial diagnostic reagents (ELISA or PCR kits) for the detection of specific antibodies. This validation procedure will give access to the Belgian market..

 

Diagnostic reagents used within an official animal disease program commissioned by the FASFC are validated by the CODA-CERVA and this is conducted according to the procedure PRO/4.3/03. and following the Ministerial Decree assigning the analyses for which National Reference Laboratories are charged with the quality control of the diagnostic reagents and fixing the procedure of this control (MB nr. 2017013635 - 25 th of October 2017 - Annexe p 96106)

 

Moniteur - Staatsblad


This procedure does not concern any selected tender.


Briefly, this procedure consists of 2 phases:
• Phase 1 is the actual initial control of the diagnostic reagents (kits) with as a result the official publication of the list of producers/distributors and/or the commercial names of the diagnostic reagents (kits) which comply with the administrative and technical minimum criteria which were predefined by the CODA-CERVA.

  • PRO/4.3/03: CODA-CERVA executes the administrative and technical evaluation of the reagents making use of the minimum criteria.

or

  • PRO5.2/01: CODA-CERVA accepts a previously published list of validated reagents from a (non) EU member state, based on mutual recognition of the validation procedure of the foreign NRL making use of the minimum criteria.

• Phase 2 consists of a batch control by the CODA-CERVA-VAR, for each lot/batch of these validated diagnostic reagents (kits) destined for the Belgian market.

 

Contact : This e-mail address is being protected from spambots. You need JavaScript enabled to view it

 

The proposed diagnostic reagents (kits) must comply with "minimum criteria" and must be "fit for purpose", i.e. suitable for the Belgian market / Official Program. The criteria and the purposes are defined for each separate Initial Control by CODA-CERVA, in concertation with FASFC and the expert committee, based on the OIE guidelines in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, 2014: Principles and methods of validation of diagnostic assays for infectious diseases (Chapter 1.1.6. - Version May 2013).

 

The list of the Initial Control Procedures since 2010

 

Initial Control

Procedure

Reference

Type

State

Publication + Criteria

Cert_IBRgB_2010

PRO/4.3/03

1693

Ab ELISA

completed

Lien sous construction

Cert_AUJgB_2011

PRO/4.3/03

16181

Ab ELISA

completed

Lien sous construction

Cert_QFever_2011

PRO/4.3/03

16190

Ab ELISA

completed

Lien sous construction

SuppCert_IBRgB_2012

PRO/4.3/03

1693

Ab ELISA

completed

Lien sous construction

Cert_BLT8_2012

PRO/4.3/03

16191

Ab ELISA

completed

Lien sous construction

Cert_BVDV_2012

PRO/4.3/03

16195

Ag ELISA

completed

Lien sous construction

SuppCert_IBRgB_2013

PRO/4.3/03

1693

Ab ELISA

completed

Lien sous construction

SuppCert_BLT8_2013

PRO/4.3/03

16191

Ab ELISA

completed

Lien sous construction

Rec_BVD_2014

/

/

RT-PCR


completed

Lien sous construction

Cert_IBRgE_2014

PRO/4.3/03

16201

Ab ELISA


completed

Lien sous construction

Cert_BVDV_2015

PRO/4.3/03

16202

Ab ELISA

completed

 

Liste of kits/protocoles validated for Belgian market

 

List of validated batches

See webpage "kits control"

 

Team

Diagnostic Control

NRL's

 

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