Abou El Hassan Mohamed, Lin Dan C C, Earle Tammy, Spencer Megan, Blasutig Ivan M
Department of Clinical Biochemistry, University Health Network, Toronto, ON, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada; Clinical Chemistry Division, Provincial Laboratory Services, Queen Elizabeth Hospital, Charlottetown, Prince Edward Island, Canada; Department of Pathology, Faculty of Medicine, Dalhousie University, Halifax, NS, Canada.
Department of Clinical Biochemistry, University Health Network, Toronto, ON, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
Clin Biochem. 2016 Jun;49(9):723-725. doi: 10.1016/j.clinbiochem.2016.03.010. Epub 2016 Apr 23.
Testing for 25-hydroxyvitamin D (25(OH)D) has increased dramatically over the past decade and several automated immunoassays exist to measure serum 25(OH)D. Here we assess the performance of the recently released automated Bio-Rad BioPlex® 2200 25-OH vitamin D immunoassay, claimed to equally detect 25(OH)D2 and 25(OH)D3, and compare its results against a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method and the well-established DiaSorin LIAISON® 25-OH vitamin D total immunoassay.
Imprecision was determined using third party controls over 20days. Linearity over the claimed measuring range was assessed using admixtures of a high and a low patient pool. Correlation between the BioPlex and LC-MS/MS (n=137) or the LIAISON (n=56) was assessed using patient samples with varying amounts of 25(OH)D3 and/or 25(OH)D2.
The total imprecision was 9.4%, 6.9% and 4.5% at concentrations of 39.4nmol/L, 70.6nmol/L and 242.8nmol/L, respectively. The assay was linear from 33.1-375.0nmol/L with a R(2) of 0.993. Method comparison revealed a strong correlation between the BioPlex assay and LC-MS/MS for samples containing 25(OH)D2 alone (n=5; R(2)=0.999), 25(OH)D3 alone (n=119; R(2)=0.935) and both (n=13; R(2)=0.919). In samples tested by all three methods (n=56), the correlation between the BioPlex and the LIAISON (R(2)=0.853) was poorer than that of the BioPlex and LC-MS/MS (R(2)=0.942).
The BioPlex assay is suitable for the measurement of total serum 25(OH)D. The strong correlation between the BioPlex assay and LC-MS/MS in detecting 25(OH)D2 and 25(OH)D3 provides evidence that the BioPlex assay is capable of the equivalent detection of both forms.
在过去十年中，25-羟维生素D（25(OH)D）检测急剧增加，并且有几种自动化免疫测定法可用于测量血清25(OH)D。在此，我们评估最近发布的自动化伯乐BioPlex® 2200 25-羟维生素D免疫测定法的性能，该方法据称能同等检测25(OH)D2和25(OH)D3，并将其结果与液相色谱-串联质谱（LC-MS/MS）法以及成熟的索灵LIAISON® 25-羟维生素D总免疫测定法进行比较。
使用第三方对照在20天内测定不精密度。通过高、低患者样本混合液评估在声称的测量范围内的线性。使用含有不同量25(OH)D3和/或25(OH)D2的患者样本评估BioPlex与LC-MS/MS（n = 137）或LIAISON（n = 56）之间的相关性。
在浓度为39.4nmol/L、70.6nmol/L和242.8nmol/L时，总不精密度分别为9.4%、6.9%和4.5%。该测定法在33.1 - 375.0nmol/L范围内呈线性，R²为0.993。方法比较显示，对于仅含25(OH)D2的样本（n = 5；R² = 0.999）、仅含25(OH)D3的样本（n = 119；R² = 0.935）以及两者都含的样本（n = 13；R² = 0.919），BioPlex测定法与LC-MS/MS之间存在强相关性。在所有三种方法都检测的样本（n = 56）中，BioPlex与LIAISON之间的相关性（R² = 0.853）比BioPlex与LC-MS/MS之间的相关性（R² = 0.942）要差。
BioPlex测定法适用于测量血清总25(OH)D。BioPlex测定法与LC-MS/MS在检测25(OH)D2和25(OH)D3方面的强相关性提供了证据表明BioPlex测定法能够同等检测这两种形式。
