Abstract
Aim. The purpose of this study was to compare the accuracy and clinical implications of three commercial enzyme-linked immunosorbent assay (ELISA) kits (Eagle Biosciences, Immundiagnostik, and MicroVue) with a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the measurement of serum 25(OH)D concentration. Methods. Blood samples were obtained from 225 healthy individuals who were recruited as subjects from Loughborough University, UK. Plasma samples were measured for 25(OH)D concentration by means of LC-MS/MS and ELISA kits from Eagle Biosciences, Immundiagnostik, and MicroVue. Results. The 25(OH)D concentration measured by the Eagle Biosciences, Immundiagnostik, and MicroVue ELISAs biased −50.9 ± 79.1 nmol/L, −14.2 ± 91.0 nmol/L, and −7.2 ± 18.9 nmol/L (bias ± SD) from the LC-MS/MS method, respectively. We found that 52% (Eagle Biosciences), 48% (Immundiagnostik), and 38% (MicroVue) of participants were misclassified, and the results showed the poor agreement (Kappa: −0.201~0.251) in classification of participants defined as vitamin D sufficiency and insufficiency between each method and LC-MS/MS. Conclusions. The present study demonstrated that there were negative biases and considerable misclassification of participants using the cut-off point (50 nmol/L) for vitamin D insufficiency and sufficiency using the Eagle Biosciences, Immundiagnostik, and MicroVue ELISAs compared with the LC-MS/MS assay.
Highlights
There have been growing demands for measurement of vitamin D status because of the high prevalence of vitamin D insufficiency and the discovery of vitamin D nonclassical functions [1, 2]
The 25(OH)D concentration measured by the Eagle Biosciences assay was significantly lower than the LC-MS/MS assay (Eagle Biosciences: 46.1 ± 29.0 nmol/L, LC-MS/MS: 97.0 ± 77.0 nmol/L; P = 0.001) and biased −50.9 ± 79.1 nmol/L from the LC-MS/MS assay (Table 1 and Figure 1(b))
The data of our study showed that 52% (15/29) of participants were misclassified when the results from the Eagle Biosciences assay were compared with those from the LC-MS/MS assay
Summary
There have been growing demands for measurement of vitamin D status because of the high prevalence of vitamin D insufficiency and the discovery of vitamin D nonclassical functions [1, 2]. The high prevalence of vitamin D insufficiency in the general population worldwide has been documented in a large number of studies [3]. Measurement of plasma 25-hydroxy vitamin D (25(OH)D) concentration is widely used in clinical practice and research reports to assess vitamin D status. Vitamin D can be obtained either from dietary sources or the epidermal layer of the skin via exposure to sunlight. 25(OH)D plasma levels > 100 nmol/L are defined as optimal vitamin D status and levels from 50 to 100 nmol/L are defined as adequate. Serum levels of 25(OH)D < 50 nmol/L are proposed to define inadequate vitamin D status, and values
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