Validation conform ISO-15189 of assays in the field of autoimmunity: Joint efforts in The Netherlands

Leontine Mulder*, Renate van der Molen, Carin Koelman, Ester van Leeuwen, Anja Roos, Jan Damoiseaux

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

10 Citations (Web of Science)

Abstract

ISO 15189:2012 requires validation of methods used in the medical laboratory, and lists a series of performance parameters for consideration to include. Although these performance parameters are feasible for clinical chemistry analytes, application in the validation of autoimmunity tests is a challenge. Lack of gold standards or reference methods in combination with the scarcity of well-defined diagnostic samples of patients with rare diseases make validation of new assays difficult. The present manuscript describes the initiative of Dutch medical immunology laboratory specialists to combine efforts and perform multi-center validation studies of new assays in the field of autoimmunity. Validation data and reports are made available to interested Dutch laboratory specialists. (C) 2018 Elsevier B.V. All rights reserved.
Original languageEnglish
Pages (from-to)513-517
Number of pages5
JournalAutoimmunity Reviews
Volume17
Issue number5
DOIs
Publication statusPublished - 1 May 2018

Keywords

  • Validation
  • ISO 15189
  • Autoantibodies
  • Quality
  • STANDARDIZATION

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