TY - JOUR
T1 - The upper reference limit for thyroid peroxidase autoantibodies is method-dependent
T2 - A collaborative study with biomedical industries
AU - Tozzoli, Renato
AU - D'Aurizio, Federica
AU - Ferrari, Anna
AU - Castello, Roberto
AU - Metus, Paolo
AU - Caruso, Beatrice
AU - Perosa, Anna Rosa
AU - Sirianni, Francesca
AU - Stenner, Elisabetta
AU - Steffan, Agostino
AU - Villalta, Danilo
PY - 2016/1/15
Y1 - 2016/1/15
N2 - Background: The determination of the upper reference limit (URL) for thyroid peroxidase autoantibodies (TPOAbs) is a contentious issue, because of the difficulty in defining the reference population. The aim of this study was to establish the URL (eURL) for TPOAbs, according to the National Academy of Clinical Biochemistry (NACB) guidelines and to compare them with those obtained in a female counterpart, by the use of six commercial automated platforms. Methods: 120 healthy males and 120 healthy females with NACB-required characteristics ( 0.05). Conclusions: Despite the analytical harmonization, the wide dispersion of the results and the differences of the eURLs between methods suggest the need of further studies focusing on TPO antigen preparations as the possible source of variability between different assays. In addition, the lack of clinical significant difference between males and females, in terms of TPOAb eURLs, confirms the suitability of the NACB recommendations.
AB - Background: The determination of the upper reference limit (URL) for thyroid peroxidase autoantibodies (TPOAbs) is a contentious issue, because of the difficulty in defining the reference population. The aim of this study was to establish the URL (eURL) for TPOAbs, according to the National Academy of Clinical Biochemistry (NACB) guidelines and to compare them with those obtained in a female counterpart, by the use of six commercial automated platforms. Methods: 120 healthy males and 120 healthy females with NACB-required characteristics ( 0.05). Conclusions: Despite the analytical harmonization, the wide dispersion of the results and the differences of the eURLs between methods suggest the need of further studies focusing on TPO antigen preparations as the possible source of variability between different assays. In addition, the lack of clinical significant difference between males and females, in terms of TPOAb eURLs, confirms the suitability of the NACB recommendations.
KW - Autoimmune thyroid diseases
KW - Automation
KW - Harmonization
KW - Immunoassay
KW - Thyroid peroxidase autoantibodies
KW - Upper reference limit
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U2 - 10.1016/j.cca.2015.10.025
DO - 10.1016/j.cca.2015.10.025
M3 - Article
C2 - 26519836
AN - SCOPUS:84946600001
VL - 452
SP - 61
EP - 65
JO - Clinica Chimica Acta
JF - Clinica Chimica Acta
SN - 0009-8981
ER -