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 | ||
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Name of the Diagnostic Kit | Avian Influenza Disease Antibody Test Kit | |
Name of the Manufacturer | BioChek UK Ltd | |
Contact | ||
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 | |
Validation Studies Abstract | ||
User’s Manual/Kit Insert |
WHITE SPOT DISEASE | ||
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Name of the Diagnostic Kit | IQ 2000TM WSSV Detection and Prevention System | |
Name of the Manufacturer | GeneReach Biotechnology Corp | |
Contact | ||
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 | |
Validation Studies Abstract | ||
User’s Manual/Kit Insert |
WHITE SPOT DISEASE | ||
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Name of the Diagnostic Kit | IQ PlusTM WSSV Kit with POCKIT System | |
Name of the Manufacturer | GeneReach Biotechnology Corp | |
Contact | ||
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
| |
Validation Studies Abstract | ||
User’s Manual/Kit Insert |
BOVINE SPONGIFORM ENCEPHALOPATHY | ||
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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 | |
Validation Studies Abstract | ||
User’s Manual/Kit Insert |
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY | ||
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Name of the Diagnostic Kit | TeSeETM Western Blot | |
Name of the Manufacturer | Bio-Rad | |
Contact | ||
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 | |
Validation Studies Abstract | ||
User’s Manual/Kit Insert |
SALMONELLOSIS | ||
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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 | |
Date and Number of Registration | May 2011 | |
Validation Studies Abstract | AS CTS AS CTS – Supplementary Data | |
User’s Manual/Kit Insert |
SALMONELLA ABORTUS OVIS | ||
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Name of the Diagnostic Kit | Salmonella Abortusovis Test | |
Name of the Manufacturer | DIATHEVA s.r.l. | |
Contact | ||
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 | |
Validation Studies Abstract | ||
User’s Manual/Kit Insert |
BOVINE TUBERCULOSIS | ||
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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 Delegatessee Resolution No 30 adopted in May 2023 by the World Assembly of WOAH Delegates | |
Date and Number of Registration | May 2012 Renewal: May 2023 | |
Validation Studies Abstract | ||
User’s Manual/Kit Insert |
BOVINE TUBERCULOSIS | ||
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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 Delegatessee Resolution No 30 adopted in May 2023 by the World Assembly of WOAH Delegates | |
Date and Number of Registration | May 2015 | |
Validation Studies Abstract | VAS Bovigam (May 2023) | |
User’s Manual/Kit Insert |
BOVINE TUBERCULOSIS | ||
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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 | |
Validation Studies Abstract | VAS Enferplex (May 2023) | |
User’s Manual/Kit Insert | User’s Manual User’s Manual (May 2023) |
NEWCASTLE DISEASE | ||
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Name of the Diagnostic Kit | Newcastle Disease Virus antibody detection ELISA | |
Name of the Manufacturer | BioChek UK Ltd | |
Contact | ||
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 | ||
User’s Manual/Kit Insert | User’s Manual |
CONTAGIOUS EQUINE METRITIS | ||
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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 | ||
User’s Manual/Kit Insert | User’s Manual |
MIDDLE EAST RESPIRATORY SYNDROME | ||
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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 Delegatessee Resolution No 30 adopted in May 2023 by the World Assembly of WOAH Delegates | |
Date and Number of Registration | May 2016 Registration Number: 20160212Renewal: May 2023 | |
Validation Studies Abstract | Renewal: BIONOTE® Rapid MERS-CoV Ag Test Kit | |
User’s Manual/Kit Insert | User’s Manual User’s Manual (August 2023) |
AFRICAN SWINE FEVER | |
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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 |
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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) | |
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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]