The register of diagnostic kits: OIE - World Organisation for Animal Health

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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 2000^TMWSSV 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 Plus^TM 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		TeSeE^TM 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 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		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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Register of diagnostic kits certified by the OIE as validated as fit for purpose