Akademik Veri Yönetim Sistemi
SCANDINAVIAN JOURNAL OF CLINICAL & LABORATORY INVESTIGATION, cilt.79, sa.1-2, ss.117-122, 2019 (SCI-Expanded)
Laboratory tests are an integral part of clinical decision making. Therefore, measurement uncertainty comes into prominence in the context of the accuracy of the laboratory result. This study aims to investigate measurement uncertainty of 14 immunoassay analytes, to compare them with different quality goals and to utilize them in the result interpretation. Measurement uncertainties of 14 immunoassay analytes were estimated by using internal and external quality control data by using Nordtest approach. Expanded uncertainties (U) were compared with allowable total error (TEa%), permissible relative deviation in the external quality assessment (PRDEQA%) and permissible expanded uncertainty for external quality assessment (pU(EQAS)%). Uncertainties were incorporated into the calculation of reference change values (RCV) and uncertainty adjusted reference intervals. RCVs of 14 analytes were calculated by three different methods reported by Harris, Clinical Laboratory Standards Institute (CLSI), and National Pathology Accreditation Advisory Council (NPAAC). Measurement uncertainties of TSH, estradiol, LH, progesterone, prolactin, and vitamin B12 were within defined allowable limits. Uone-sided FT3 and Uone-sided ferritin exceeded defined TEa% but U-FT3 and U-ferritin were found below the limits of pU(EQAS)%. Measurement uncertainties of FT4, cortisol, DHEAS, FSH, testosterone, and folate did not meet the specification limits. Recently defined permissible expanded uncertainty promises new targets to compare estimated measurement uncertainty. Measurement uncertainty should be applied to the laboratory result interpretation within the scope of RCV and reference interval to obviate misdiagnosis. Furthermore, we suggest that laboratories should inform clinicians about the tests with high uncertainties to assist them making the right clinical diagnosis.