Rajme-Manzur D, Hernández-Reyes M, Cruz-Soca M, Padron-Fajardo L

Language: Spanish
References: 0
Page: 81-87
PDF size: 115.51 Kb.

ABSTRACT

The objective of this work was to obtain and validate a buffered Brucella abortus antigen for plaque agglutination test as the basic diagnostic test for bovine brucellosis. Three batches of antigen were formulated from the multiplication of strain 99 of Brucella abortus. Quality controls (determination of pH, cell volume, sterility, buffering capacity) and serological tests for performance evaluation were performed. 1070 bovine serum samples (350 positive and 720 negative) previously tested with the established diagnostic tests were used. Diagnostic and relative sensitivity and specifi city, positive predictive values and negative predictive values, effi cacy and concordance were determined. In all lots the evaluated characteristics proved to be within the parameters established for this type of product. Diagnostic specifi city and sensitivity were 99.5% and 100%, respectively. The positive predictive values was 99.1%, the negative predictive values was 100% and the effi cacy was 99.7%. The antigen showed a relative sensitivity and specifi city of 100% and the concordance was classifi ed as very good. The performance evaluation showed satisfactory results, demonstrating that the production method used is feasible to obtain a product with adequate efficiency.