Ministry of Agriculture, Livestock, Fisheries and Food SANIT ANIMAL Resolution 128/2001 Implement the diagnostic test Elisa's test for the "Certification of Officially Free Establishments of Bovina Enzootic Leucosis".

Bs. As., 19/2/2001

VISTO file No. 15.513/99 of the registration of the NATIONAL SERVICE OF SANITY AND AGROALIMENTARY QUALITY, Resolution No. 337 of 28 May 1994 of the former NATIONAL SERVICE OF ANIMAL SANITY, and

CONSIDERING:

That in the recommendations of the IV National Workshop of Enzootic Leucosis Bovina, carried out in the ARGENTINA REPUBLIC on August 22, 1998, it is suggested that the ELISA technique be implemented in any of its variants, ELISA INDIRECTO or ELISA DE BLOQUEO to be used as a diagnostic laboratory test in the "Certification of Officially Free Establishments of Leucosis".

That the working groups represented by the NATIONAL INSTITUTE OF AGROPULARY TECHNOLOGY (INTA), FACULTAD OF VETERINARY SCIENCES of the NATIONAL UNIVERSITY OF THE CENTRE of the Province of BUENOS AIRES (UNCPBA), the VETERNATIVE SCIENCE FACULTY of the NATIONAL UNIVERSITY OF THE PLATATIVE

Having decided through the inter-agency standing group on Leucosis Enzootic Bovina (LeB Group), the use of the ELISA TEST as the main technique, the sensitivity, specificity and repetitibility of this technique and the comparison of that sensitivity with the Agar Gel (AGID) Immunodifusion Test, which has already been officially recognized.

That for such purposes the three (3) study groups mentioned, each represented by a technical professional, who developed his own "KIT" of ELISA, taking as a reference a foreign commercial team already validated in the said Agency and executed by a technical professional of the same.

That in terms of the results achieved it was concluded that ELISA's technique has a greater sensitivity than the Immunodifusion in Agar Gel (AGID).

That without prejudice to the provisions of Resolution No. 337 of 28 May 1994 of the former NATIONAL SERVICE OF ANIMAL SANITY that establishes a system of certification of free establishments of Enzootic Leucosis Bovina in the ARGENTINA REPUBLIC using the Test of Immunodifusion in Gel Agar (AGID) as official test, is proposed to be an alternative diagnostic test

That all laboratories that have the qualification to grant diagnostics with official validity may do so by one or both tests, as they have fulfilled the requirements required by the Official Laboratory.

That the Manual of the INTERNATIONAL OFFICE OF EPIZOOTIAS (OIE) allows the use of both techniques, so for official diagnoses that do not include the Officially Free Establishment Certifications, the Network Laboratories, will use the technique they consider to be of choice.

That the institutions or companies that produce "KITS" ELISA that wish to market them should complete the requirements of the Directorate of Agrochemicals, Pharmacological and Veterinary Products and of the Directorate of Laboratory and Technical Control, both of the NATIONAL SERVICE OF SANITY and AGROALIMENTARY QUALITY, and present all the series for their control in the Central Laboratory evaluating the same sensitivity and specificity.

That it is necessary to ensure the sanitary category of non-reactants in those bovines for export, implementing a technique of greater sensitivity to the Immunodifusion Test in Agar Gel (AGID) represented by the ELISA Test, avoiding its use and possible conflicts in the sale of animals standing for the MERCADO COMUN DEL SUR (MERCOSUR).

That the Board of Directors of the NATIONAL SERVICE OF AGROALIMENTARY SANITY AND QUALITY has taken the appropriate intervention.

That the LEGAL DIRECTION of the AREA of AGRICULTURA, GANADERIA, PESCA and ALIMENTATION of the General DIRECTION OF JURIDIC MATTERS of the MINISTERIO DE ECONOMIA, has taken the intervention that belongs to it.

That the subscriber is competent to resolve in this instance, pursuant to Decree No. 20 of 13 December 1999, pursuant to article 8 of Decree No. 1585 of 19 December 1996.

Therefore,

THE SECRETARY OF AGRICULTURA, GANADERIA, PESCA AND ALIMENTATION

RESUELVE:

Article 1 Imple the diagnostic test ELISA Test, for the "Certification of Officially Free Enzootic Leucosis Establishments Bovina (LEB)" without prejudice to maintaining the validity of Resolution No. 337 of 28 May 1994 of the former NATIONAL SERVICE OF ANIMAL SANITY. Art. 2° Labs that have the qualification for the granting of official diagnostics may choose one or both tests, having met the requirements required by the Official Laboratory.

Art. 3rd The institutions or companies that produce for the commercialization of the KITS ELISA must comply with the requirements of the Directorate of Agrochemicals, Pharmacological and Veterinary Products and the Directorate of Laboratories and Technical Control of the NATIONAL SERVICE OF SANITY AND AGROALIMENTARY QUALITY, with presentation of all the series for its evaluation of sensitivity, specificity and repeatability in the Central Laboratory. Art. 4° This resolution shall enter into force from the date of its publication in the Official Gazette. Art, 5° Please, give yourself to the National Directorate of the Official Register and archvese. . Antonio T. Berhongaray.