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Vaccimonitor

versión impresa ISSN 1025-028Xversión On-line ISSN 1025-0298

Resumen

RAJME-MANZUR, David; HERNANDEZ-REYES, Marian; CRUZ-SOCA, Meilyn  y  PADRON-FAJARDO, Leslie. Evaluation of a Brucella abortus antigen for plaque agglutination as screening test in the diagnosis of bovine brucellosis. Vaccimonitor [online]. 2017, vol.26, n.3, pp.81-87. ISSN 1025-028X.

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 specificity, positive predictive values and negative predictive values, efficacy and concordance were determined. In all lots the evaluated characteristics proved to be within the parameters established for this type of product. Diagnostic specificity and sensitivity were 99.5% and 100%, respectively. The positive predictive values was 99.1%, the negative predictive values was 100% and the efficacy was 99.7%. The antigen showed a relative sensitivity and specificity of 100% and the concordance was classified as very good. The performance evaluation showed satisfactory results, demonstrating that the production method used is feasible to obtain a product with adequate efficiency

Palabras clave : Brucella abortus; plaque agglutination test; brucellosis.

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