Produção de soro de referência anti-Brucella abortus segundo as normas para materiais de referência certificados.

Abstract

Reference materials play an important role in ensuring the quality of analytical results, however, in many areas, especially the biological; the low availability of these materials makes it difficult to demonstrate the technical competence of laboratories. Brucellosis is an endemic zoonosis in our country and it is associated with the consumption of contaminated milk and dairy products. To ensure the reliability of the diagnostic techniques used in the official program for the control and eradication of this disease in Brazil, there is no reference material available that can be widely used. In this work, a candidate for reference material for the serological diagnosis of brucellosis was developed from serum of naturally infected cow. The presence of Brucella abortus bv. was proven through isolation and identification by modified PCR-AMOS. The material was produced and evaluated according to the requirements of ISO 17034 and ISO Guide 35. Four independent serological techniques were used: the buffered acidified antigen test, slow agglutination in tubes and reduction by 2-mercaptoethanol, complement fixation and fluorescent polarization. The candidate reference material was considered homogeneous (p> 0.05) and the uncertainty associated with the assessment of homogeneity between units and within unit was determined. In the stability tests, the material was considered stable even when submitted to a temperature condition of 25ºC ± 2ºC for 12 days and, still, it was stable after four repeated thawing cycles. The results obtained show the potential of this material to be further characterized and used as a national reference serum.