He Cheng-Shiun, Gleeson Michael, Fraser William D
School of Sport, Exercise and Health Sciences, Loughborough University, Leicestershire, Loughborough LE11 3TU, UK.
Norwich Medical School, University of East Anglia, Norwich NR4 7TJ, UK.
ISRN Nutr. 2013 Aug 13;2013:723139. doi: 10.5402/2013/723139. eCollection 2013.
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.
目的。本研究旨在比较三种商用酶联免疫吸附测定（ELISA）试剂盒（Eagle Biosciences、Immundiagnostik和MicroVue）与经过验证的液相色谱-串联质谱（LC-MS/MS）方法在测量血清25(OH)D浓度方面的准确性和临床意义。方法。从英国拉夫堡大学招募的225名健康个体中采集血样。通过LC-MS/MS以及Eagle Biosciences、Immundiagnostik和MicroVue的ELISA试剂盒测量血浆样本中的25(OH)D浓度。结果。Eagle Biosciences、Immundiagnostik和MicroVue ELISA测量的25(OH)D浓度与LC-MS/MS方法相比，偏差分别为-50.9±79.1 nmol/L、-14.2±91.0 nmol/L和-7.2±18.9 nmol/L（偏差±标准差）。我们发现，52%（Eagle Biosciences）、48%（Immundiagnostik）和38%（MicroVue）的参与者被错误分类，并且在将参与者分类为维生素D充足和不足时，各方法与LC-MS/MS之间的结果显示出较差的一致性（Kappa值：-0.201至0.251）。结论。本研究表明，与LC-MS/MS测定法相比，使用Eagle Biosciences、Immundiagnostik和MicroVue ELISA针对维生素D不足和充足采用截断点（50 nmol/L）时，存在负偏差且参与者有相当比例被错误分类。
