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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	[email protected]
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 2000^TMWSSV Detection and Prevention System
Name of the Manufacturer	GeneReach Biotechnology Corp
Contact	[email protected]
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 Plus^TM WSSV Kit with POCKIT System
Name of the Manufacturer	GeneReach Biotechnology Corp
Contact	[email protected]
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	Thermo Fisher Prionics
Contact	[email protected]
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 (discontinued from 31/12/2020)
Validation Studies Abstract	AS Prionics® – Check WESTERN
User’s Manual/Kit Insert	User’s Manual

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY
Name of the Diagnostic Kit	TeSeE^TM Western Blot
Name of the Manufacturer	Bio-Rad
Contact	[email protected]
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	[email protected] for technical questions [email protected] 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 User’s Manual (short protocol)

SALMONELLA ABORTUS OVIS
Name of the Diagnostic Kit	Salmonella Abortusovis Test
Name of the Manufacturer	DIATHEVA s.r.l.
Contact	[email protected]
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	[email protected]
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	[email protected]
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	[email protected]
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	[email protected]
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 see Resolution No. 30 adopted in May 2021 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	[email protected]
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: [email protected]

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