For an efficient and reasonable accreditation of allergen specific IgE
| Autor: | Pascale Nicaise-Roland, Claude Lambert, Thierry Tabary, Béatrice Uring-Lambert, Séverine Brabant, Catherine Lainé, P.A. Apoil, Anne Sarrat, Céline Vigneron, Eric Charbonnier, Jean Sainte-Laudy, Marie-Alexandra Alyanakian, Françoise Bienvenu, Délia Jaby, Gilles Renier |
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| Rok vydání: | 2013 |
| Předmět: |
Quality Control
Calibration curve Computer science Cost-Benefit Analysis media_common.quotation_subject Validation Studies as Topic Sensitivity and Specificity Accreditation Hypersensitivity Calibration Humans Quality (business) Limit (mathematics) media_common Reproducibility Clinical Laboratory Techniques Uncertainty Reproducibility of Results General Medicine Gold standard (test) Repeatability Allergens Immunoglobulin E Reliability engineering Practice Guidelines as Topic Laboratories |
| Zdroj: | Annales de biologie clinique. 71:325-332 |
| ISSN: | 0003-3898 |
| DOI: | 10.1684/abc.2013.0830 |
| Popis: | 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). |
| Databáze: | OpenAIRE |
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