THE VALIDATION PROTOCOL USED FOR BIO-RAD TESEE TEST: A PRACTICAL APPROACH

A.I. ARDELEAN USAMV CLUJ
MIHAELA DUMA Directia Sanitara Veterinara si pentru Siguranta Alimentelor Cluj, Laborator Sanitar Veterinar de Stat
M. MIHIU USAMV CLUJ

DOI: https://doi.org/10.15835/buasvmcn-asb:64:1-2:1826

Keywords: validation, sensitivity, specificity, quality management

Abstract

The present studies have the purpose to in house validation of the BioRad TeSeE ELISA test used for rapid TSE diagnosis. The samples used was: bovine brain homogenate, positive control, negative control and blank sample. The result of performance parameters evaluated from bovine brain homogenate was: repeatability 0.0108; intermediate precision 0.0247; accuracy 100%, Chi square almost absolute 0.00; sensitivity 100%; specificity 100%; linearity present, detection limit arbitrary estimated at dilution 1/8 and quantification limit at dilution 1/4. Considering this results, the validation protocol fulfill the quality management requirements.

Published

2009-09-29

Issue

Vol. 64 No. 1-2 (2007): Bulletin of University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca. Animal Science and Biotechnologies

Section

Research Articles

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