title: [For an efficient and reasonable accreditation of allergen specific IgE].
abstract: French medical laboratories must be accredited before November 2016 according to NF/EN/ISO 15189 standard. However, technical accreditation guidelines cannot be applied literally for the determination of specific IgE for several reasons: more than 600 allergen tests, lack of international gold standard, limited external quality controls. Furthermore, the technique for determination of specific IgE is CE DM-IVD marked, common to all specificities, automatised, standardized according to a single calibration curve. Thus, we propose an efficient but reasonable solution conform to the idea of the accreditation by validating the process. We recommend: a flexible extend type A; choice of only one representative allergen (Dermatophagoides pteronyssinus) for repeatability and precision (20 tests, 2 levels 0.5-1 and 8-12 kUA/L) performed on patients sera, reproducibility (30 consecutive determinations using an Internal Quality Control/IQC), accuracy (IQC and rare External Quality Controls) compared with peers. Sensitivity, specificity, dynamic range, detection threshold are determinated by the provider. Linearity may be checked if the laboratory practices sample dilution for values higher than the upper limit guaranteed by the provider. In the absence of international gold standard, the uncertainty is not measurable. In case of change of instrument, the results obtained by the systems must be compared through 35 tests of different specificities distributed across the range of calibration and including 5 values close to the detection limit. This methodology allows a scientifically effective verification, technically and financially reasonable, to ensure the excellence of the performance of the laboratory with regard to peers and users (allergologists and patients).
authors.affiliation: Laboratoire d'immunologie, CHU Bordeaux, Hôpital Pellegrin, Bordeaux, France. anne.sarrat@chu-bordeaux.fr
authors.forename: Anne
authors.initials: A
authors.lastname: Sarrat
authors.forename: Séverine
authors.initials: S
authors.lastname: Brabant
authors.forename: Eric
authors.initials: E
authors.lastname: Charbonnier
authors.forename: Marie-Alexandra
authors.initials: MA
authors.lastname: Alyanakian
authors.forename: Pol-André
authors.initials: PA
authors.lastname: Apoil
authors.forename: Françoise
authors.initials: F
authors.lastname: Bienvenu
authors.forename: Délia
authors.initials: D
authors.lastname: Jaby
authors.forename: Catherine
authors.initials: C
authors.lastname: Lainé
authors.forename: Pascale
authors.initials: P
authors.lastname: Nicaise-Roland
authors.forename: Gilles
authors.initials: G
authors.lastname: Renier
authors.forename: Jean
authors.initials: J
authors.lastname: Sainte-Laudy
authors.forename: Thierry
authors.initials: T
authors.lastname: Tabary
authors.forename: Béatrice
authors.initials: B
authors.lastname: Uring-Lambert
authors.forename: Céline
authors.initials: C
authors.lastname: Vigneron
authors.forename: Claude
authors.initials: C
authors.lastname: Lambert
mesh_terms: D000068:Accreditation / Q000592:standards*; D000485:Allergens / Q000276:immunology*; D019411:Clinical Laboratory Techniques / Q000191:economics / Q000379:methods / Q000592:standards*; D003362:Cost-Benefit Analysis; D006801:Humans; D006967:Hypersensitivity / Q000097:blood / Q000175:diagnosis / Q000276:immunology; D007073:Immunoglobulin E / Q000032:analysis* / Q000276:immunology; D007753:Laboratories / Q000191:economics / Q000331:legislation & jurisprudence* / Q000592:standards; D017410:Practice Guidelines as Topic; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D035501:Uncertainty; D054928:Validation Studies as Topic
chemical_list: D000485:Allergens; D007073:Immunoglobulin E
keywords: accreditation; allergy; quality control; specific IgE antibodies