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The register of diagnostic kits

Register of diagnostic kits certified by WOAH 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 27 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 27 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 27 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 26 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 see Resolution No 19 adopted in May 2017 by the World Assembly of OIE Delegates see Resolution No 30 adopted in May 2023 by the World Assembly of WOAH Delegates
Date and Number of Registration	May 2012 Registration Number: 20120107 Renewal: May 2017 Renewal: May 2023
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 Prionics Lelystad B.V. (May 2023)
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 see Resolution No 30 adopted in May 2023 by the World Assembly of WOAH Delegates
Date and Number of Registration	May 2015 Registration Number: 20150110 Extension of the claim: May 2023 (051319)
Validation Studies Abstract	AS Bovigam VAS Bovigam (May 2023)
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 see Resolution No 30 adopted in May 2023 by the World Assembly of WOAH Delegates
Date and Number of Registration	May 2019 Registration Number: 20190113 Additional claims: May 2023 (111824)
Validation Studies Abstract	AS Enferplex VAS Enferplex (May 2023)
User’s Manual/Kit Insert	User’s Manual User’s Manual (May 2023)

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 see Resolution No 30 adopted in May 2021 by the World Assembly of the OIE Delegates see Resolution No 30 adopted in May 2023 by the World Assembly of WOAH Delegates
Date and Number of Registration	May 2016 Registration Number: 20160212 Renewal: May 2023
Validation Studies Abstract	AS Rapid MERS-CoV Test Renewal: BIONOTE® Rapid MERS-CoV Ag Test Kit
User’s Manual/Kit Insert	User’s Manual User’s Manual (August 2023)

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	[email protected]
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

FOOT AND MOUTH DISEASE VIRUS (FMDV)	Serotypes A, O and Asia -1
Name of the Diagnostic Kit	VDRG® FMDV 3Diff/PAN Ag Rapid Kit
Name of the Manufacturer	MEDIAN Diagnostics Inc.
Contact	[email protected]
Type of Kit	Lateral flow test or pen-side test
Purpose(s) Validated	see Resolution No 30 adopted in May 2023 by the World Assembly of WOAH Delegates
Date and Number of Registration	May 2023 Registration Number: WOAH 022029
Validation Studies Abstract	AS VDRG FMDV
User’s Manual/Kit Insert	User’s Manual

INFECTION OF WHITE SPOT SYNDROME VIRUS (WSSV)
Name of the Diagnostic Kit	Innocreate Bioscience WSSV RP Rapid Test Kit
Name of the Manufacturer	Innocreate Bioscience Co., Ltd.
Contact	[email protected]
Type of Kit	Lateral flow immunochromatographic assay (LFIA)
Purpose(s) Validated	see Resolution No 31 adopted in May 2023 by the World Assembly of WOAH Delegates
Date and Number of Registration	May 2023 Registration Number: 082132
Validation Studies Abstract	AS Innocreate WSSV RP
User’s Manual/Kit Insert	User’s Manual

Contact: [email protected]

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