The Irish Equine Foundation Ltd.

Transcription

1 The Irish Equine Foundation Ltd. Trading as The Irish Equine Centre and its wholly owned subsidiary Irish Diagnostic Laboratory Services (IDLS) Ltd. Johnstown, Naas, Co.Kildare Testing Laboratory Registration number: 151T is accredited by the Irish National Board (INAB) to undertake testing as detailed in the Schedule bearing the Registration Number detailed above, in compliance with the International Standard ISO/IEC 17025: nd Edition General Requirements for the Competence of Testing and Calibration Laboratories (This Certificate must be read in conjunction with the Annexed Schedule of ) Date of award of accreditation: 05:04:2004 Date of last renewal of accreditation: 27:03:2014 Expiry date of this certificate of accreditation: 27:03:2019 This shall remain in force until further notice subject to continuing compliance with INAB accreditation criteria, ISO/IEC and any further requirements specified by the Irish National Board. Manager: Chairperson: Dr Adrienne Duff Mr Tom O Neill Issued on 27 March 2014 Organisations are subject to annual surveillance and are re-assessed every five years. The renewal date on this Certificate confirms the latest date of renewal of accreditation. To confirm the validity of this Certificate, please contact the Irish National Board. The INAB is a signatory of the European co-operation for (EA) Testing Multilateral Agreement (MLA) and the International Laboratory Cooperation (ILAC) Mutual Recognition Arrangement. Edition 25, 24/05/ T Page 1 of 20

2 Schedule of (Annex to Certificate) Trading as The Irish Equine Centre and its wholly owned subsidiary Irish Diagnostic Laboratory Services (IDLS) Ltd. Biological, Chemical and Veterinary Testing Laboratory Initial Registration Date : 5-April-2004 Postal Address: (Address of other locations as they apply) Johnstown Naas Co Kildare Telephone: +353 (45) Fax: +353 (45) Contact Name: Tom Buckley Facilities: Public testing service Edition 25, 24/05/ T Page 2 of 20

3 Schedule of THE IRISH NATIONAL ACCREDITATION BOARD (INAB) is the Irish body for the accreditation of organisations including laboratories. Laboratory accreditation is available to testing and calibration facilities operated by manufacturing organisations, government departments, educational institutions and commercial testing/calibration services. Indeed, any organisation involved in testing, measurement or calibration in any area of technology can seek accreditation for the work it is undertaking. Each accredited laboratory has been assessed by skilled specialist assessors and found to meet criteria which are in compliance with ISO/IEC or ISO/IEC (medical laboratories). Frequent audits, together with periodic inter-laboratory test programmes, ensure that these standards of operation are maintained. Testing and Calibration Categories: : Permanent laboratory calibration and testing where the laboratory is erected on a fixed location for a period expected to be greater than three years. Category B: Category C: Category D: Site calibration and testing that is performed by staff sent out on site by a permanent laboratory that is accredited by the Irish National Board. Site calibration and testing that is performed in a site/mobile laboratory or by staff sent out by such a laboratory, the operation of which is the responsibility of a permanent laboratory accredited by the Irish National Board. Site calibration and testing that is performed on site by individuals and organisations that do not have a permanent calibration/testing laboratory. Testing may be performed using (a) (b) (c) (d) portable test equipment a site laboratory a mobile laboratory or equipment from a mobile or site laboratory Standard Specification or Test Procedure Used: The standard specification or test procedure that is accredited is the issue that is current on the date of the most recent visit, unless otherwise stated. Glossary of Terms Facilities: Public calibration/testing service: Conditionally available for public calibration/testing: Normally not available for public calibration/testing: Commercial operations which actively seek work from others. Established for another primary purpose but, more commonly than not, is available for outside work. Unavailable for public calibration/testing more often than not. Laboratory users wishing to obtain assurance that calibration or test results are reliable and carried out to the Irish National Board criteria should insist on receiving an accredited calibration certificate or test report. Users should contact the laboratory directly to ensure that this scope of accreditation is current. INAB will, on request, verify the status and scope. Edition 25, 24/05/ T Page 3 of 20

4 Biological Testing Laboratory Tests on veterinary pharmaceutical and biological products Other tests (Animal Tissues) Type of test/properties measured Detection (not including identification) of anti-microbial substances in animal tissues. Equipment/techniques used Documented in-house six plate method: P5.091 based on EC four Plate Method 1974 Bogaerts and Wolfe Edition 25, 24/05/ T Page 4 of 20

5 Biological Testing Laboratory 811 Microbiological tests on foods Type of test/properties measured Equipment/techniques used Documented in-house methods.03 Meat and meat Product wash method for the P5.053 based on ISO products, game and isolation of Salmonella from poultry : 2017 poultry.03 Meat and meat Isolation of Salmonella from poultry, P5.020 products, game and (including primary production stage). Based on ISO : poultry Poultry products and food samples Animal Feeds.21 Others Boot socks Hatcher basket liners Faecal material Swabs Dust.03 Meat and meat products, game and poultry Detection of campylobacter species from poultry and poultry products Detection of Trichinella in porcine and equine muscle by magnetic stirrer method for pepsin digestion. P5.065 based on ISO : 2006 Documented in house method P based on EC 2075/2005, official controls for Trichinella in Meat 2005, OJ L 338/60 Detection of Listeria monocytogenes and other listeria species. P5.061 based on ISO , 1996/AMD 1:2004 Edition 25, 24/05/ T Page 5 of 20

6 Biological Testing Laboratory Tests on Foods/Stockfoods and their Additives Other tests (Animal Feeding Stuffs) Type of test/properties measured Method for the analysis of animal feeding stuffs for constituents of animal origin (Qualitative) Equipment/techniques used Documented in-house methods P5.089 based on Commission Regulation (EC) 152/2009 amended by Commission regulation (EU) No 51/2013. Extraction of ruminant DNA by realtime PCR by Commission Regulation P5.127 P5.128 P5.129 based on Commission Regulation (EC) 52/2009 amended by Commission regulation (EU) No 51/ Microbiological tests on other materials Compost Microbiological method for the enumeration of E.coli and the detection of Salmonella. P5.126 based on BSI PAS:100 Specification for composted material and ISO : Testing of Surfaces in Abattoirs Documented in-house.01 Meat Surfaces Detection of specified risk material method by ELISA.02 Product Contact P Surfaces Edition 25, 24/05/ T Page 6 of 20

7 Chemical Testing Laboratory Biological monitoring Drugs and drug metabolites Type of test/properties measured Screening methods for the detection of veterinary drug residues in animal tissues, biological fluids, honey and water (See detailed list in Annex I) Equipment/techniques used Documented in-house methods. Corticosteroids in bovine, equine, porcine and ovine urine & bovine and caprine milk P (by ELISA) Corticosteroids in fish P (by ELISA) Trenbolone in avian liver & avian and porcine serum Trenbolone in bovine urine P (by ELISA) P (by ELISA) Testosterone in bovine serum P (by ELISA) Stilbenes in porcine and avian serum, avian liver and bovine, ovine, porcine, equine and cervine urine P (by ELISA) Estradiol in bovine serum P (by Immulite) Sulphonamides in avian muscle and honey P (by Biochip) Edition 25, 24/05/ T Page 7 of 20

8 Chemical Testing Laboratory Biological monitoring Drugs and drug metabolites Type of test/properties measured Screening methods for the detection of veterinary drug residues in animal tissues, biological fluids, honey and water Equipment/techniques used Documented in-house methods Boldenone in bovine, porcine and ovine urine P (by ELISA) Chloramphenicol in egg, avian liver and tissue, honey, avian serum and porcine urine P (by ELISA) Chloramphenicol in bovine and caprine milk P (by ELISA) Chloramphenicol in fish P (by ELISA) Methyltestosterone in porcine serum P (by ELISA) Methyltestosterone in fish P (by ELISA) Edition 25, 24/05/ T Page 8 of 20

9 Chemical Testing Laboratory Biological monitoring Drugs and drug metabolites Type of test/properties measured Screening methods for the detection of veterinary drug residues in animal tissues, biological fluids, honey and water Stanozolol/16-beta-hydroxystanozolol in bovine urine Equipment/techniques used Documented in-house methods P (by ELISA) Estradiol in fish P (by ELISA) Estradiol and ethinylestradiol in bovine and caprine milk P (by ELISA) Phenylbutazone in bovine, equine and porcine plasma P (by ELISA) Streptomycin in honey P (by ELISA) Nortestosterone in bovine urine P (by ELISA) Ethinylestradiol in bovine and porcine urine P (by ELISA) Progesterone in bovine serum P (by Immulite) Synthetic steroids in bovine urine P (by Biochip) Edition 25, 24/05/ T Page 9 of 20

10 Chemical Testing Laboratory Type of test/properties measured Phenylbutazone in equine plasma Equipment/techniques used Documented in-house methods by ELISA P based on detection of phenylbutazone in equine plasma. FEI: Veterinary regulations 11th Edition Jan Biological monitoring Screening methods for the Documented in house detection of veterinary drug method residues in animal tissues and.21 Drugs and drug biological fluids metabolites Bacitracin in bovine, porcine and P (by ELISA) avian muscle LOD/CCB 10ng/g Beta-agonists (clenbuterol) in P (by ELISA) bovine urine and avian liver (clenbuterol, cimbuterol, mabuterol and brombuterol) Note: procedures on pages 7-10 are screening methods only that may produce presumptive positive results which may then be forwarded to a confirmatory laboratory. Note: see Annex 1 for list of Analytes, Matrices and Limits of Detection. Edition 25, 24/05/ T Page 10 of 20

11 Chemical Testing Laboratory 756 Drugs & Pharmaceuticals Type of test/properties measured Equipment/techniques used.01 Equine plasma/serum Presence or absence of 40 prohibited P substances. by UPLC-TOF MS List is maintained by the laboratory. Edition 25, 24/05/ T Page 11 of 20

12 Veterinary Testing Laboratory Bacteriology Diagnostic bacteriology incorporating identification by simple microscopy, cultural methods of detection and identification of organisms Type of test/properties measured Examination of specimens/swabs for Taylorella equigenitalis, Klebsiella pneumoniae and Pseudomonas aeruginosa Equipment/techniques used P5.052 Based on OIE Terrestrial Manual 2012, Chapter CEM Code of Practice on Contagious equine metritis: Edition 25, 24/05/ T Page 12 of 20

13 Veterinary Testing Laboratory 1314 Virology Type of test/properties measured Equipment/techniques used.01 Diagnostic Virology Non-cultural (immunological) methods of detection - - equine Detection and quantification of antibodies in serum to equine influenza by single radial haemolysis (SRH) test Documented in house method P2.022 based on OIE Terrestrial Manual 2008 chapter Equine Influenza Section 2b Virology.01 Diagnostic Virology Non-cultural (immunological) methods of detection Detection of antibodies in serum/plasma directed against bluetongue virus VP7 protein using ID Vet celisa kit. PA2.020 based on EC 1266/ bovine Detection of antibodies to PA2.023 based on OIE bovine viral diarrhoea (BVD) in Manual Chapter for milk and serum/plasma using BVD the IDEXX ELISA kit. Detection of antibodies to PA2.024 based on OIE bovine herpesvirus I (BHV-1) manual for IBR (IBR) in milk and serum/plasma using the IDEXX ELISA kit. Detection of antibodies to the PA2.026 based on OIE ge antigen of bovine manual chapter herpesvirus type 1 (BHV-1) (IBR) using the IDEXX BHV-1 kit Edition 25, 24/05/ T Page 13 of 20

14 Veterinary Testing Laboratory 1314 Virology Type of test/properties measured Equipment/techniques used.01 Diagnostic Virology Non-cultural (immunological) methods of detection - porcine Detection of antibodies to porcine reproductive and respiratory syndrome virus (PRRSV) in serum by ELISA Documented in house method PA2.042 based on IDEXX ELISA kit insert Porcine reproductive and respiratory syndrome virus antibody test kit insert Virology.03 Immunological Detection of bovine viral PA2.025 based on OIE methods for antigen diarrhoea virus (BVDV) antigens manual chapter detection in serum, plasma and ear notch - bovine tissue using the IDEXX antigen test kit. Edition 25, 24/05/ T Page 14 of 20

15 Veterinary Testing Laboratory Virology Identification by molecular techniques (Quantitative) - equine Virology Identification by molecular techniques (Qualitative) -equine Type of test/properties measured Molecular method for the quantification of influenza type A nucleic acid in nasal swabs Molecular method for the detection of influenza type A nucleic acid in nasal swabs and confirmation of equine influenza Equipment/techniques used Applied Biosystems PCR Vet Max Taqman Kit Insert PM2.023 Based on: OIE manual, Chapter and Reference Journal of Veterinary Diagnostic Investigation PM2.032 based on: AgPath-ID One-Step RT-PCR Kit User Guide (Applied Biosystems; Rev G) Vetmax - Plus One-Step RT- PCR Kit Protocol (Applied Biosystems; Rev C, 09/2010) OIE manual, Chapter PM2.019 Kingfisher extraction PM2.019 or PM2.009 manual extraction Virology Molecular and screening PM2.015 based on OIE.05 Identification by method for the detection of Manual 2010 (online) molecular techniques bovine viral diarrhoea (BVD) Chapter (Qualitative) virus nucleic acid in serum, Kingfisher extraction - bovine EDTA blood, milk and ear notch procedure PM2.019 tissue. (Quantitative) Molecular method for the Applied Biosystems OCR Vet - equine quantification of equine Max Taqman Kit Insert herpesvirus Type 1 (EHV) PM2.022 Based on: OIE nucleic acid in nasal swabs & Manual, Chapter and heparinised bloods. Reference Journal of Edition 25, 24/05/ T Page 15 of 20

16 Veterinary Testing Laboratory Type of test/properties measured Equipment/techniques used Diagnostic Investigation (Qualitative) Molecular method for the Documented LSI RT-PCR - porcine detection of porcine Taqman Kit for the reproductive and respiratory detection of PRRS. syndrome virus (PRRSV) nucleic PM2.021 Based on: OIE acid in oral fluids, blood and Manual, Report of the OIE semen. AD HOC group on PRRS Virology PM2.034 based on:.01 Diagnostic virology Detection of equine herpesvirus AgPath-ID One Step RT-PCR - Non-cultural type 1 nucleic acid Kit Protocol & VetMax-ID (Immunological One-Step RT-PCR Protocol. methods of detection) Kingfisher extraction (Qualitative) PM2.019 or manual - equine extraction PM Virology.04 Haemagglutination Haemagglutination inhibition P2.014 inhibition procedure for the detection P2.014 based on the OIE - equine and quantification of equine Terrestrial Manual (2015) influenza virus antibodies in Chapter serum 1315 Prions.02 Detection of prion Qualitative detection of BSE P based on EU protein by prion protein by using the validated test method for immunological Prionics-check Priostrip test for BSE detection methods brain tissue and spinal cord (cattle) Edition 25, 24/05/ T Page 16 of 20

17 Veterinary Testing Laboratory 1311 Bacteriology Type of test/properties measured Equipment/techniques used.99 Enzyme linked Detection of Leptospira SOP P immunosorbent assays interrogans antibodies in PrioCHECK kit. bovine serum Parasitology.02 Immunological Detection of Neospora caninum SOP P methods of antibodies in bovine serum. INGEZIM test kit. identification 1371 Johne s Disease.30 Molecular methods of Analysis of bovine, ovine and SOP P detection and caprine faecal samples for the by PCR - ADIAVET PARATB identification detection of Mycobacterium Real Time kit. avium subsp. paratuberulosis (MAP) using real-time Polymerase Chain Reaction (PCR) technology..13 Enzyme linked Analysis of bovine serum / milk PARACHEK 2 test kit immunosorbent assays samples for the presence of SOP P5.114 antibodies to Mycobacterium avium subsp. paratuberulosis Edition 25, 24/05/ T Page 17 of 20

18 Annex 1 Analytes, Matrices and Limits of Detection Analyte Matrix/Species SOP Reference Validated Limit Boldenone Chloramphenicol Urine/bovine, P porcine and ovine 1.5 µg/l Egg P µg/kg Milk/bovine, P caprine 0.20 µg/l Liver tissue/avian P µg/kg Honey P µg/kg Serum/avian P µg/l Urine/porcine P µg/l Fish P µg/kg Clenbuterol Liver/avian P µg/kg Urine/bovine P µg/l Liver/avian P µg/kg Urine/bovine,ovine, P Hexestrol porcine,equine, 1.0 µg/l Cervine Serum/porcine, P Avian 2.0 µg/l Liver/avian P µg/kg Urine/bovine,ovine, P Dienestrol porcine,equine, 1.0 µg/l cervine Serum/porcine, P avian 2.0 µg/l Liver/avian P µg/kg Urine/bovine,ovine, P Diethylstilbesterol porcine,equine, 1.0 µg/l cervine Serum/porcine, P avian 2.0 µg/l Liver/avian P µg/kg Trenbolone Serum/avian, P porcine 2.0 µg/l Urine/bovine P µg/kg Methyltestosterone Serum/porcine P µg/l Fish P µg/kg Specified Risk Material Swabs P % Edition 25, 24/05/ T Page 18 of 20

19 Annex 1 Continued Analytes, Matrices and Limits of Detection Analyte Matrix/Species SOP Reference Validated Limit Progesterone Serum/bovine P µg/l Stanozolol+16-Beta-Hydroxy-Stanozolol Urine/bovine P µg/l Testosterone Serum (female) P µg/l Serum (male) P µg/l /bovine Fish P µg/kg Estradiol Milk/bovine, P caprine 1.0 µg/l Serum/bovine P µg/l Milk/bovine, P Ethinylestradiol caprine 1.0 µg/l Urine/bovine P µg/l Streptomycin Honey P µg/kg Phenylbutazone Plasma/bovine, P Equine, porcine 5.0 µg/l Nortestosterone Urine/bovine P µg/l Sulphonamides Sulphadiazine Sulphadimethoxine Sulphathiazole Sulphasoxazole Sulfamethoxypyridazine Sulphachloropyridazine Sulphamethazine Sulphapyridine Sulphamerazine Sulphamethiazole Muscle/avian Honey P P µg/kg 25 µg/kg Sulphadoxine Synthetic steroids in Urine Methyltestosterone Ethinylestradiol Medroxyprogesterone acetate Corticosteroids Dexamethasone Urine/bovine P µg/l 0.5 µg/l 0.5 µg/l Urine/bovine, P equine, porcine, 2.0 ng/ml ovine Milk/bovine, P caprine 1.0 ng/ml Fish P ng/g Edition 25, 24/05/ T Page 19 of 20

20 Annex 1 Continued Analytes, Matrices and Limits of Detection Analyte Matrix/Species SOP Reference Validated Limit Corticosteroids Betamethasone Corticosteroids Flumethasone Bacitracin Urine/bovine, P Equine, porcine, 4.0 ng/ml ovine Milk/bovine, P caprine 2.0 ng/ml Fish P ng/g Urine/bovine, P equine, porcine, 4.0 ng/ml ovine Milk/bovine, P caprine 2.0 ng/ml Fish P ng/g Tissue/bovine, P porcine and avian 10 ng/g Edition 25, 24/05/ T Page 20 of 20