title: Quality management in reference tests for the diagnosis of classical swine fever.
abstract: Inter-laboratory comparison tests for the diagnosis of classical swine fever (CSF) have been established by the national swine fever laboratories of European Union (EU) Member States. They provide a method of measuring both the quality of the results of diagnostic tests performed by laboratories and the competence with which they were performed. The objective is that all laboratories obtain the same result when investigating the same sample. This study evaluates the results of serological and virological reference tests for CSF (neutralisation test and virus isolation) performed over a period of three years. The sensitivity of the serological diagnosis for the detection of CSF antibodies was very good and revealed a tolerance limit of the scored antibody titres of one dilution step. Results on the same sample in two consecutive years were similar. The variation of the scored antibody titres was larger when testing sera with a low CSF antibody titre. The interpretation of the antibody titres as 'CSF positive or negative' was only slightly altered by these variations. The backtitration of a neutralisation test (used as a control measure) is a more mathematical value which does not correlate directly with the biological system. Commercial CSF antibody enzyme-linked immunosorbent assays still display a lower sensitivity on individual samples compared to the reference neutralisation test. Classical swine fever virus isolation was well established in all participating laboratories and caused very few problems. Specificity of CSF diagnosis by investigating CSF antibody and CSF virus negative sera was not problematic either. In general, the reference tests for CSF diagnosis are well established in the EU. They are based on living systems, e.g. cells and virus, and consequently they have a different tolerance limit than pure mathematical values. What is important is that the interpretation of the test result is identical in all laboratories.
authors.affiliation: Institute for Animal Health, Mars-la-Tour Strasse 1 26121 Oldenburg, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Floegel-Niesmann
authors.forename: V
authors.initials: V
authors.lastname: Moennig
mesh_terms: D000818:Animals; D000914:Antibodies, Viral / Q000097:blood*; D006691:Classical Swine Fever / Q000175:diagnosis*; D006692:Classical Swine Fever Virus / Q000276:immunology* / Q000302:isolation & purification*; D019411:Clinical Laboratory Techniques / Q000592:standards / Q000662:veterinary*; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards / Q000662:veterinary; D005062:European Union; D009500:Neutralization Tests / Q000592:standards / Q000662:veterinary; D011786:Quality Control; D012016:Reference Values; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods / Q000662:veterinary; D013552:Swine
chemical_list: D000914:Antibodies, Viral