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Home > Scientific expertise > Registration of diagnostic kits > The register of diagnostic kits

Register of diagnostic kits certified by the OIE as validated as fit for purpose

'Fit for purpose' means that the kit has to be validated to such a level to show that the kit's results can be interpreted to have a defined meaning in terms of diagnosis or another biological property being examined.

AVIAN INFLUENZA

Name of the Diagnostic Kit

 

Avian Influenza Disease Antibody Test Kit

Name of the Manufacturer

BioChek UK Ltd

Contact

info@biochek.com

Type of Kit

ELISA

Purpose(s) Validated

see Resolution No XXVII adopted in May 2008 by the World Assembly of the OIE Delegates

 

Date and
Number of Registration

May 2008
Registration Number: 20080203

 

Validation Studies Abstract

AS Avian Influenza Disease Antibody Test Kit

User's Manual/Kit Insert

User's Manual

WHITE SPOT DISEASE

Name of the Diagnostic Kit

 

IQ 2000TM WSSV Detection and Prevention System

Name of the Manufacturer

GeneReach Biotechnology Corp

Contact

sales@genereach.com

Type of Kit

PCR

Purpose(s) Validated

see Resolution No XXVII adopted in May 2008 by the World Assembly of the OIE Delegates

 

Date and
Number of Registration

May 2008
Registration Number: 2008030

 

Validation Studies Abstract

AS IQ 2000

User's Manual/Kit Insert

User's Manual

WHITE SPOT DISEASE

Name of the Diagnostic Kit

 

IQ PlusTM WSSV Kit with POCKIT System

Name of the Manufacturer

GeneReach Biotechnology Corp

Contact

sales@genereach.com

Type of Kit

Insulated isothermal PCR

Purpose(s) Validated

see Resolution No 26 adopted in May 2013 by the World Assembly of the OIE Delegates

 

Date and
Number of Registration

May 2013
Registration Number: 20130108

 

Validation Studies Abstract

AS IQPlus

User's Manual/Kit Insert

User's Manual IQPlus

User's Manual Pockit System

BOVINE SPONGIFORM ENCEPHALOPATHY

Name of the Diagnostic Kit

 

Prionics® - Check WESTERN

Name of the Manufacturer

Prionics

Contact

info@prionics.com

Type of Kit

Western Blot

Purpose(s) Validated

see Resolution No XXVII adopted in May 2008 by the World Assembly of the OIE Delegates

 

Date and
Number of Registration

May 2008
Registration Number: 20080102

 

Validation Studies Abstract

AS Prionics® - Check WESTERN

User's Manual/Kit Insert

User's Manual

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY

Name of the Diagnostic Kit

 

TeSeETM Western Blot

Name of the Manufacturer

Bio-Rad

Contact

tse@bio-rad.com

Type of Kit

Western Blot

Purpose(s) Validated

see Resolution No XXVI adopted in May 2009 by the World Assembly of the OIE Delegates

 

Date and
Number of Registration

May 2009
Registration Number: 20090105

 

Validation Studies Abstract

AS TeSeE WB

User's Manual/Kit Insert

User's Manual

SALMONELLOSIS

Name of the Diagnostic Kit

 

Check&Trace Salmonella

Name of the Manufacturer

Check-Points B.V.

Contact

serovar@check-points.com for technical questions

info@check-points.com for general questions

Type of Kit

Multiplex LDR PCR reaction followed by detection on a diagnostic micro array

Purpose(s) Validated

see Resolution No 24 adopted in May 2011 by the World Assembly of the OIE Delegates
see Resolution No.20 adopted in May 2020 by the World Assembly of the OIE Delegates

 

Date and
Number of Registration

May 2011
Registration Number: 20110106

 

Validation Studies Abstract

AS CTS
AS CTS – Supplementary Data

User's Manual/Kit Insert

User's Manual

SALMONELLA ABORTUS OVIS

Name of the Diagnostic Kit

 

Salmonella Abortusovis Test

Name of the Manufacturer

DIATHEVA s.r.l.

Contact

info@diatheva.com

Type of Kit

ELISA

Purpose(s) Validated

see Resolution No.20 adopted in May 2020 by the World Assembly of the OIE Delegates

 

Date and
Number of Registration

May 2020
Registration Number: 20200215

 

Validation Studies Abstract

AS Diatheva Salmonella Abortusovis

User's Manual/Kit Insert

User's Manual

BOVINE TUBERCULOSIS

Name of the Diagnostic Kit

 

Mycobacterium bovis Antibody Test Kit

Name of the Manufacturer

IDEXX Laboratories

Contact

lpdtechservices@idexx.com

Type of Kit

Indirect ELISA

Purpose(s) Validated

see Resolution No 24 adopted in May 2012 by the World Assembly of the OIE Delegates

 

Date and
Number of Registration

May 2012
Registration Number: 20120107

 

Validation Studies Abstract

AS MBAT

User's Manual/Kit Insert

User's Manual

BOVINE TUBERCULOSIS

Name of the Diagnostic Kit

 

BOVIGAM® - Mycobacterium bovis Gamma interferon test kit for cattle

Name of the Manufacturer

Thermo Fisher Scientific Prionics AG

Contact

info@prionics.com

Type of Kit

Sandwich ELISA

Purpose(s) Validated

see Resolution No 34 adopted in May 2015 by the World Assembly of the OIE Delegates
see Resolution No.20 adopted in May 2020 by the World Assembly of the OIE Delegates

 

Date and
Number of Registration

May 2015
Registration Number: 20150110

 

Validation Studies Abstract

AS Bovigam

User's Manual/Kit Insert

User's Manual

BOVINE TUBERCULOSIS

Name of the Diagnostic Kit

 

Enferplex Bovine TB antibody test

Name of the Manufacturer

Enfer Scientific ULC

Contact

info@enfergroup.com

Type of Kit

Indirect chemiluminescent multiplex ELISA

Purpose(s) Validated

see Resolution No 31 adopted in May 2019 by the World Assembly of the OIE Delegates

 

Date and
Number of Registration

May 2019
Registration Number: 20190113

 

Validation Studies Abstract

AS Enferplex

User's Manual/Kit Insert

User's Manual

NEWCASTLE DISEASE

Name of the Diagnostic Kit

 

Newcastle Disease Virus antibody detection ELISA

Name of the Manufacturer

BioChek UK Ltd

Contact

info@biochek.com

Type of Kit

ELISA

Purpose(s) Validated

see Resolution No 29 adopted in May 2014 by the World Assembly of the OIE Delegates

 

Date and
Number of Registration

May 2014

Registration Number: 20140109

 

Validation Studies Abstract

AS BioChek Newcastle ELISA

User's Manual/Kit Insert

User's Manual

CONTAGIOUS EQUINE  METRITIS

Name of the Diagnostic Kit

 

Pourquier® IIF Taylorella equigenitalis

Name of the Manufacturer

IDEXX Laboratories

Contact

www.idexx.com

Type of Kit

Indirect immuno fluorescence test

Purpose(s) Validated

see Resolution No 15 adopted in May 2016 by the World Assembly of the OIE Delegates

 

Date and
Number of Registration

May 2016

Registration Number: 20160111

 

Validation Studies Abstract

AS IIF

User's Manual/Kit Insert

User's Manual

MIDDLE EAST RESPIRATORY SYNDROME

Name of the Diagnostic Kit

 

BIONOTE® Rapid MERS-CoV Ag Test

Name of the Manufacturer

BioNote, Inc

Contact

bionote@bionote.co.kr

Type of Kit

Immuno chromatographic assay

Purpose(s) Validated

see Resolution No 15 adopted in May 2016 by the World Assembly of the OIE Delegates

 

Date and
Number of Registration

May 2016

Registration Number: 20160212

 

Validation Studies Abstract

AS Rapid MERS-CoV Test

User's Manual/Kit Insert

User's Manual

AFRICAN SWINE FEVER

Name of the Diagnostic Kit

 

VetMAX™ African Swine Fever Virus Detection Kit

Name of the Manufacturer

Thermo Fisher Scientific LSI S.A.S.

Contact

 

Type of Kit

Taqman® real time PCR

Purpose(s) Validated

see Resolution No.20 adopted in May 2020 by the World Assembly of the OIE Delegates

 

Date and
Number of Registration

May 2020

Registration Number:20200114

 

Validation Studies Abstract

AS VetMAX ASF

User's Manual/Kit Insert

User's Manual



 

Contact: oie-srdk@oie.int

 

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