Standardization of diagnostic methods. Patrizia Rossi

Transcription

1 Standardization of diagnostic methods Patrizia Rossi Istituto Superiore di Sanità, Rome, Italy

2 What is a standard? International Standards provide a reference framework, or a common technological language, between suppliers and their customers - which facilitates trade and the transfer of technology. Standardization is achieved through consensus agreements between national delegations representing all the economic stakeholders concerned - suppliers, users, government regulators and other interest groups, such as consumers. They agree on specifications and criteria to be applied consistently in the classification of materials, in the manufacture and supply of products, in testing and analysis,, in terminology and in the provision of services.

3 Standards in parasitology ISO 15553:2006 Water quality - Isolation and identification of Cryptosporidium oocysts and Giardia cysts from water This standard specifies a method that is applicable for the detection and enumeration of Cryptosporidium oocysts and Giardia cysts in water. It is applicable for the examination of surface and ground waters, treated waters, mineral waters, swimming pool and recreational waters. This method does not allow identification to species level, the host species of origin or the determination of viability or infectivity of any Cryptosporidium oocyst or Giardia cyst which may be present For food safety against parasites developing into the food available able methods i.e. veterinary inspection at the slaughterhouse (for the detection of cysticerci) ) and at the fish market (for the detection of Anisakidae larvae and plerocercoids) laboratory test for the detection of Trichinella larvae are still not standardized Commission Regulation N 2075/2005 (02/12/2005) applied from January According to the regulation carcasses of domestic swine shall be systematically sampled in slaughterhouses and examined by the magnetic stirred digestion method (reference method) which is not yet standardized

4 Standardization issues in parasitology Lack of standard methods in parasitology Lack of international reference materials for parasites Commercial in vitro diagnostic kits often unreliable

5 Standardization bodies ISO is a network of the national standards institutes of 157 countries, on the basis of one member per country, with a Central Secretariat in Geneva, G Switzerland, that coordinates the system. ISO is a non-governmental organization: its members are not, as is the case in the United Nations system, delegations of national governments. ISO CEN is the European Committee for Standardization, founded in 1961 by the national standards bodies in the European Economic Community and EFTA countries. CEN CEN,, with CENELEC (the( European Committee for Electrotechnical Standardization) and ETSI ( the European Telecommunications Standards Institute) are the three European standardization bodies recognized as competent in the area of voluntary technical standardization and listed in Annex I of the Union Directive 98/34/EC concerning 'the information ion procedure' for standards and technical regulations. Together they y prepare European Standards in specific sectors of activity and the three make up the 'European standardization system'. Most standards are prepared at the request of industry. The European Commission can also request the standards bodies to prepare standards in order to implement European legislation. This standardization is 'mandated' mandated' ' by the Commission, through the Standing Committee of the Directive, in support of the legislation.

6 CEN Technical Committees Most of our European Standards and other approved documents have been drawn up in Technical Committees. Usually standards in support of legislation or which require a high level of participation and consensus will continue to be drawn up in the same way.

7 CEN/TC 275 Food analysis Horizontal methods Published standards EN ISO 16140:2003 EN ISO 16654:2001 EN ISO 20837:2006 Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods (ISO 16140:2003) Microbiology of food and animal feeding stuffs - Horizontal method for the detection of Escherichia coli O157 (ISO 16654:2001) Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - Requirements for sample preparation for qualitative detection (ISO 20837:2006) EN ISO 20838:2006 Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - Requirements for amplification and detection for qualitative methods (ISO 20838:2006)

8 CEN/TC 275 Food analysis Horizontal methods SC/WG CEN/TC 275/WG 0 CEN/TC 275/WG 2 CEN/TC 275/WG 4 CEN/TC 275/WG 5 CEN/TC 275/WG 6 CEN/TC 275/WG 9 CEN/TC 275/WG 10 CEN/TC 275/WG 11 CEN/TC 275/WG 12 Title General considerations Sweeteners Pesticides in foods of plant origin Biotoxins Microbial contamination Vitamins and Carotenoids Trace elements (heavy metals) Genetically modified foodstuffs Food allergens

9 The 26th meeting of ISO/TC34/SC9 and of the 14th meeting of CEN/TC275/WG6 Second Workshop of NRLs for The meetings were held on April 2007, in Cairo, Egypt hosted by the Egyptian Standardisation Organisation (OES) More than 50 delegates attended the meetings, representing 15 countries and 5 international organizations in liaison. Australia was represented for the first time. CRLs representatives attending the meeting: L. monocytogenes and staphylococci (Bertrand Lombard) CRL Salmonella (Kirsten Mooijman) CRL E. coli (Stefano Morabito) CRL Bivalve molluscs (Rachel Rangdale) CRL Campylobacter (Ingrid Hanson) CRL parasites (Patrizia Rossi)

10 The CEN/TC275/WG6 Standard projects Technical Advisory Group (TAG) 6 TAGs at present Resolution 149 CRLP Proposal Creation of TAG 7: Parasites Establishment of the standard method for the detection of anti- Trichinella antibodies in swine