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

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

[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: Resolution 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 PlusTM 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: Resolution 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

 TeSeETM 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

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 KitVetMAX™ African Swine Fever Virus Detection Kit
Name of the ManufacturerThermo Fisher Scientific LSI S.A.S.
Contact[email protected]
Type of KitTaqman® real time PCR
Purpose(s) Validatedsee Resolution No 20 adopted in May 2020 by the World Assembly of the OIE Delegates
Date and Number of RegistrationRegistration Number: 20200114
May 2020: Resolution No 20
Validation Studies AbstractAS VetMAX ASF
User’s Manual/Kit InsertUser’s Manual

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

INFECTION OF WHITE SPOT SYNDROME VIRUS (WSSV)
Name of the Diagnostic KitInnocreate Bioscience WSSV RP Rapid Test Kit
Name of the ManufacturerInnocreate Bioscience Co., Ltd.
Contact[email protected]
Type of KitLateral flow immunochromatographic assay (LFIA)
Purpose(s) Validatedsee Resolution No 31 adopted in May 2023 by the World Assembly of WOAH Delegates
Date and Number of RegistrationRegistration Number: 082132
May 2023: Resolution No 31
Validation Studies AbstractAS Innocreate WSSV RP
User’s Manual/Kit InsertUser’s Manual

AFRICAN SWINE FEVER VIRUS (ASFV)Qualitative immunochromatographic assay for the detection of antibodies against African swine fever virus (ASFV) in porcine serum
Name of the Diagnostic KitSentinel® ASFV Antibody Rapid Test
Name of the ManufacturerExcelsior Bio-System Incorporation
Contact[email protected]
Type of KitImmuno-chromatographic lateral flow assay (LFA)
Purpose(s) Validated
Date and Number of RegistrationProcedure Number: 062233
Validation Studies AbstractSentinel® ASFV Antibody Rapid Test
User’s Manual/Kit Insert

AFRICAN SWINE FEVER VIRUS (ASFV)
Name of the Diagnostic KitGenelix™ ASFV Real-time PCR Detection kit
Name of the ManufacturerSanigen Co., Ltd.
ContactTel: +82-1833-8010
Fax: +82-2-573-3134
Type of KitReal-time PCR
Purpose(s) Validated
Date and Number of Registration
Validation Studies AbstractGenelix™ ASFV Real-time PCR Detection kit
User’s Manual/Kit Insert

Contact: [email protected]