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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	Registration Number: 20080203 May 2008: Resolution No 27 2013: Resolution No 26 2018: Resolution No 19 2024: Resolution No 34
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	Registration Number: 2008030 May 2008: R esolution No 27 2013: Resolution No 26 2018: Resolution No 19
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	Registration Number: 20130108 May 2013: R esolution No 26 May 2018: Resolution No 19
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	Registration Number: 20080102 (discontinued from 31/12/2020) May 2008: Resolution No 27
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	Registration Number: 20090105 May 2009: Resolution No 26 2014: Resolution No 29 2019: Resolution No 31
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	Registration Number: 20110106 May 2011: Resolution No 24 2015: Resolution No 34 2020: Resolution No 20
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	Registration Number: 20200215 May 2020: Resolution No 20
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	Registration Number: 20120107 May 2012: Resolution No 24 2017: Resolution No 19 2023: Resolution No 30
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	Registration Number: 20150110 May 2015: Resolution No 34 2019: Resolution No 31 2023: Resolution No 30; with new additional claim: 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: Resolution No 31 Registration Number: 20190113 May 2023 (111824) : Additional claim, Resolution No 30
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	Registration Number: 20140109 May 2014: Resolution No 29 2019: Resolution No 31 2024: Resolution 34
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	Registration Number: 20160111 May 2016: Resolution No 15 2021: Resolution No 30
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	Registration Number: 20160212 May 2016: Resolution No 15 2023: Resolution No 30
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	Registration Number: 20200114 May 2020: Resolution No 20
Validation Studies Abstract	AS VetMAX ASF
User’s Manual/Kit Insert	User’s Manual

AFRICAN SWINE FEVER
Name of the Diagnostic Kit	Genelix™ ASFV Real-time PCR Detection Kit
Name of the Manufacturer	Sanigen Co., Ltd.
Contact	Tel: +82-1833-8010 Fax: +82-2-573-3134
Type of Kit	Real-time PCR
Purpose(s) Validated	see Resolution No 34 adopted in May 2024 by the World Assembly of the WOAH Delegates
Date and Number of Registration	Registration Number: 052131 30 May 2024: Resolution No 34
Validation Studies Abstract	Genelix™ ASFV Real-time PCR Detection Kit
User’s Manual/Kit Insert	User’s Manual

AFRICAN SWINE FEVER
Name of the Diagnostic Kit	Sentinel® ASFV Antibody Rapid Test
Name of the Manufacturer	Excelsior Bio-System Incorporation
Contact	[email protected]
Type of Kit	Immuno-chromatographic lateral flow assay (Rapid test)
Purpose(s) Validated	see Resolution No 34 adopted in May 2024 by the World Assembly of the WOAH Delegates
Date and Number of Registration	Registration Number: 062233 30 May 2024: Resolution No 34
Validation Studies Abstract	Sentinel® ASFV Antibody Rapid Test
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	Registration Number: WOAH 022029 May 2023: Resolution No 30
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	Registration Number: 082132 May 2023: Resolution No 31
Validation Studies Abstract	AS Innocreate WSSV RP
User’s Manual/Kit Insert	User’s Manual

Contact: [email protected]

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