TY - JOUR
T1 - Validation conform ISO-15189 of assays in the field of autoimmunity: Joint efforts in The Netherlands
AU - Mulder, Leontine
AU - van der Molen, Renate
AU - Koelman, Carin
AU - van Leeuwen, Ester
AU - Roos, Anja
AU - Damoiseaux, Jan
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85044329194&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/29545112
U2 - https://doi.org/10.1016/j.autrev.2018.03.004
DO - https://doi.org/10.1016/j.autrev.2018.03.004
M3 - Review article
C2 - 29545112
SN - 1568-9972
VL - 17
SP - 513
EP - 517
JO - Autoimmunity Reviews
JF - Autoimmunity Reviews
IS - 5
ER -