Evaluation of Virological Microparticle Enzyme Immunoassay According to the ISO 15189: Real-Life Experience in a University Hospital.

Date publication

janvier 2016

Journal

Clinical laboratory

Auteurs

Membres identifiés du Cancéropôle Est :
Dr JEULIN Hélène

Tous les auteurs :
Lafontaine S, Prin-Mathieu C, Velay A, Agulles O, Schvoerer E, Jeulin H

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/27156314

Résumé

The International Standard ISO 15189 based on the ISO 9001:2008 emphasizes specific requirements for quality and ability of medical laboratories. The accreditation of medical laboratories according to ISO 15189 includes the validation of biological methods, which depends on collection of bibliographic data and experimental proofs. Moreover, these results must be compared to provider data sheets and independent scientific data. In the immunodiagnostic field, independent published data are deeply lacking. The aim of our work was to share experience of method validation for virological immune markers on the widely used Architect i2000sr.

Mots clés

Accreditation, HIV Core Protein p24, blood, Hepatitis B Surface Antigens, blood, Hospitals, University, Humans, Immunoenzyme Techniques, standards, Laboratories, Hospital, standards

Référence

Clin. Lab.. 2016 ;62(3):275-84