Abstract
IntroductionRecently several diagnostic manufacturers have launched new 25-hydroxy-vitamin D (25[OH]D) assays, which are aligned to the National Institute of Standards and Technology (NIST) Standard Reference Materials (SRM) (NIST, Gaithersburg, Maryland). The aim of this study was to compare the performance of one liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, one enzyme linked immunosorbent assay (ELISA), and one recalibrated and previous version of a chemiluminescence immunoassay (CLIA).Material and methodsSerum-aliquots of 198 patient samples from routine 25(OH)D analysis were measured by the ClinMass® LC-MS/MS Complete Kit (RECIPE Chemicals + Instruments GmbH, Munich, Germany), the ORGENTEC 25(OH)D3/D2 ELISA (ORGENTEC Diagnostika GmbH, Mainz, Germany), the recalibrated Immunodiagnostic Systems (IDS)-iSYS 25(OH)DS and the previous used IDS-iSYS 25(OH)D CLIA (Immunodiagnostic Systems Ltd, Boldon, United Kingdom). Bland-Altman and Deming regression analyses were calculated for methods comparison of all tested 25(OH)D assays. The LC-MS/MS method was defined as the reference method. Within-run and between-run precision measurements were performed for all methods with three different concentration levels.ResultsCompared to the LC-MS/MS method, the new IDS-iSYS 25(OH)DS and ORGENTEC 25(OH)D3/D2 assay demonstrated mean relative biases of 16.3% and 17.8%. The IDS-iSYS 25(OH)D assay showed the lowest mean bias of 1.5%. Deming regression analyses of the recalibrated IDS-iSYS 25(OH)DS and the ORGENTEC 25(OH)D3/D2 assay showed proportional differences, when compared to the reference method. All assays showed a within-run and between-run imprecision of ≤ 20% at each of the evaluated concentration levels.ConclusionsThe evaluated standardized immunoassays and LC-MS/MS are useful methods for measuring 25(OH)D serum-levels in clinical laboratories.
Highlights
Several diagnostic manufacturers have launched new 25-hydroxy-vitamin D (25[OH]D) assays, which are aligned to the National Institute of Standards and Technology (NIST) Standard Reference Materials (SRM) (NIST, Gaithersburg, Maryland)
The aim of our study was to compare the previous version of one chemiluminescence immunoassay (CLIA), which is not aligned to the NIST SRM, the new follow-up version of this CLIA and one new enzyme linked immunosorbent assay (ELISA), both aligned to the NIST SRM 2972, and at least one new liquid chromatography-mass tandem spectrometry (LC-MS/MS) kit, which is aligned to the new NIST SRM 972a and able to separate and detect the C3-epimer
The LC-MS/MS method was defined as the reference method
Summary
Several diagnostic manufacturers have launched new 25-hydroxy-vitamin D (25[OH]D) assays, which are aligned to the National Institute of Standards and Technology (NIST) Standard Reference Materials (SRM) (NIST, Gaithersburg, Maryland). Vitamin D deficiency results in abnormalities in bone metabolism known as rickets, osteomalacia, and osteoporosis [2,3]. In the kidneys the biologically active form 1,25-dihydroxy-vitamin D (1,25[OH]2D) is created from 25(OH)D [7]. This active form has a circulating halflife of only 4-6 hours and serum-levels of about 1000 fold less than 25(OH)D [1,8,9]. The major circulating form of vitamin D is 25(OH)D, which has a half-life of approximately 2-3 weeks [8]. The total 25(OH)D is principally used as the biomarker indicating the vitamin D status [9,10]
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