External quality assessment programme for in vitro allergy tests: ISS/CNR scheme--the first one organized in Europe by government--and European scheme "Galileo".
Accordingly with the new tendency of employing Rast Units (RU) instead of Rast Classes (RC) in the specific-IgE testing field, is necessary that internal Quality Control (QC) and external Quality Assessment (QA) programmes take account of these RU. So far only few experiences of controlling and assessing the quality concerned with RU, have been carried out. In Italy, a National QA-scheme organised by the National Health Institute (ISS) and the National Research Council (CNR), which involves about 90 laboratories, is starting just now, and a commercial QA programme (Galileo), started in 1989, by now is the only one which helped valuate each laboratory's performance for specific-IgE assays. The results collected in a 12 months period were elaborated in different ways as they were expressed in RC or in RU and the trial confirms that the specific-IgE testing field is still far from reaching the reliability already established for other assays. So we hope the National and the Galileo schemes will help stimulate major improvements in internal precision and in between-laboratories agreement.
Pistocchi
E
E
Laboratorio di Analisi Chimico-cliniche e Microbiologiche U.S.L. n. 39, Ospedale M. Bufalini, Cesena, Italy.
Mengozzi
S
S
Delvecchio
C
C
D000485:Allergens / Q000276:immunology; D005060:Europe; D006801:Humans; D006967:Hypersensitivity / Q000175:diagnosis*; D007124:Immunoenzyme Techniques / Q000592:standards*; D007073:Immunoglobulin E / Q000032:analysis*; D011237:Predictive Value of Tests; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D011786:Quality Control; D011852:Radioallergosorbent Test / Q000379:methods / Q000592:standards*; D011863:Radioimmunoassay / Q000379:methods / Q000592:standards*; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012680:Sensitivity and Specificity
D000485:Allergens; D011933:Reagent Kits, Diagnostic; D007073:Immunoglobulin E