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

Abstract : 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.
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https://hal.univ-lorraine.fr/hal-02014290
Contributor : Evelyne Schvoerer <>
Submitted on : Monday, February 11, 2019 - 3:17:33 PM
Last modification on : Thursday, April 25, 2019 - 3:14:05 PM

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  • HAL Id : hal-02014290, version 1
  • PUBMED : 27156314

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Sophie Lafontaine, Christine Prin-Mathieu, Aurélie Velay, Odette Agulles, Evelyne Schvoerer, et al.. Evaluation of Virological Microparticle Enzyme Immunoassay According to the ISO 15189: Real-Life Experience in a University Hospital.. Clinical Laboratory, Clinical Laboratory Publications, 2016, 62 (3), pp.275-84. ⟨hal-02014290⟩

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