Gallelli Luca, Michniewicz Andzelika, Cione Erika, Squillace Aida, Colosimo Manuela, Pelaia Corrado, Fazio Alessia, Zampogna Stefania, Peltrone Francesco, Iannacchero Rosario, Sarro Giovambattista De, Working Group G Amp Sp, Salerno Monica, Di Mizio Giulio
Department of Health Science University of Catanzaro and Operative Unit of Clinical Pharmacology and Pharmacovigilance, Mater Domini Hospital, 88100 Catanzaro, Italy.
Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende Cosenza, Italy.
J Clin Med. 2019 Jun 22;8(6):895. doi: 10.3390/jcm8060895.
The aim of this study was to evaluate the performance of different analytic methods, such as liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS), high-performance liquid chromatography-ultraviolet (HPLC-UV), enzyme-linked immunosorbent assay (EIA), and chemiluminescence immunoassays (CLIA), in order to highlight whether or not there is relative superiority amongst the assays. We analyzed two groups of subjects suffering from headache and two groups of healthy subjects.
We performed a prospective, single-blind single-center control-group study on 220 subjects with migraine. Subjects of both sexes >10 years old and with 12 months' history of migraine were eligible for the study. As a control group, 120 healthy subjects were chosen by their family physician.
LC-MS/MS evaluation documented that in all enrolled subjects (migraine and control groups), the serum vitamin D3 levels were lower with respect to the normal range (30-100 ng/mL), with a mean value of 15.4 ng/mL, without difference between sex. The mean values measured using HPLC-UV, EIA, and CLIA tests such as Liaison and Architect did not show significant differences compared to the values obtained using LC-MS/MS.
In conclusion, the population generally has low values of the vitamin D3 hormone, and the suggested range should probably be revised. HPLC-UV and CLIA were found to have appropriate analytical values compared to the reference method (LC-MS/MS), so it is possible to suggest their routine use to optimize care.
本研究旨在评估不同分析方法的性能,如液相色谱-串联质谱联用(LC-MS/MS)、高效液相色谱-紫外检测法(HPLC-UV)、酶联免疫吸附测定法(EIA)和化学发光免疫分析法(CLIA),以突出这些检测方法之间是否存在相对优势。我们分析了两组头痛患者和两组健康受试者。
我们对220名偏头痛患者进行了一项前瞻性、单盲、单中心对照研究。年龄大于10岁且有12个月偏头痛病史的男女受试者均符合研究条件。作为对照组,由家庭医生挑选出120名健康受试者。
LC-MS/MS评估表明,在所有纳入的受试者(偏头痛组和对照组)中,血清维生素D3水平低于正常范围(30-100 ng/mL),平均值为15.4 ng/mL,性别之间无差异。与使用LC-MS/MS获得的值相比,使用HPLC-UV、EIA以及Liaison和Architect等CLIA检测方法测得的平均值没有显著差异。
总之,总体人群的维生素D3激素水平较低,建议的范围可能需要修订。与参考方法(LC-MS/MS)相比,发现HPLC-UV和CLIA具有合适的分析值,因此可以建议将它们用于日常检测以优化医疗护理。