title: Evaluation of Virological Microparticle Enzyme Immunoassay According to the ISO 15189: Real-Life Experience in a University Hospital.
abstract: BACKGROUND
  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.
  
  
  METHODS
  After risk analysis, intra- and inter-assay variability, and inter-sample contamination were evaluated for each method, and sensitivity was investigated for antigen detection tests. A comparison between the two Architect i2000sr available in our laboratory was also performed.
  
  
  RESULTS
  All tested methods were consistent with the manufacturer data (from the data sheet). No inter-sample contamination was observed. Both devices are broadly equivalent and can be used indifferently or as a backup solution of the other.
  
  
  CONCLUSIONS
  To our knowledge, those results are the first independent complete data on the reliability of the Architect i2000sr in real-life experience. These data are needed to the accreditation of our platform and potentially useful for the accreditation of other laboratories using the same equipment.
authors.forename: Sophie
authors.initials: S
authors.lastname: Lafontaine
authors.forename: Christine
authors.initials: C
authors.lastname: Prin-Mathieu
authors.forename: Aurélie
authors.initials: A
authors.lastname: Velay
authors.forename: Odette
authors.initials: O
authors.lastname: Agulles
authors.forename: Evelyne
authors.initials: E
authors.lastname: Schvoerer
authors.forename: Hélène
authors.initials: H
authors.lastname: Jeulin
mesh_terms: D000068:Accreditation; D016655:HIV Core Protein p24 / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006785:Hospitals, University; D006801:Humans; D007124:Immunoenzyme Techniques / Q000592:standards*; D007755:Laboratories, Hospital / Q000592:standards*
chemical_list: D016655:HIV Core Protein p24; D006514:Hepatitis B Surface Antigens