Abstract
The present studies have the purpose to in house validation of the ELISA tests used in diagnosis of fallowing viral diseases: avian influenza (AI), classical swine fever (CSF), porcine reproductive and respiratory syndrome (PRRS), bovine viral diarrhea- mucosal disease (BVD-MD), bovine infectious rhinotracheitis (BIR) and enzootic bovine leukosis (EBL). The samples used was: chicken positive serum, porcine positive serum for CSF and positive serum for PRRS, bovine positive serum for BIR, bovine negative serum for EBL, bovine positive serum for BVD-MD, positive control, negative control, serial and successive dilution of positive control. The performance parameters had the fallowing results: for AI the repeatability (r) for optical densities (DOP) 0.055, DOP intermediate precision (R) 0.0927, sensitivity (p+) and specificity (p-) 1 (100%); for CSF DOP r=0.0277, DOP R=0.0754, p+=1, p-=1; for PRRS DOP r=0.0877, DOP R=0.1589, p+=1, p-=1; for BVD-MD DOP r=0.0277, DOP R=0.0921, p+=1, p-=1; for BIR DOP r=0.0182; DOP R=0.0807, p+=1, p-=1, for EBL DOP r= 0.032, DOP R=0.0858, p+=1, p-=1. Considering these results, the validation protocol fulfills the quality management requirements, and the methods fit the purpose
Published Version
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