您的位置：山东大学 -> 科技期刊社 -> 《山东大学学报（医学版）》

山东大学学报 (医学版) ›› 2023, Vol. 61 ›› Issue (7): 90-95.doi: 10.6040/j.issn.1671-7554.0.2023.0078

• 临床医学 • 上一篇    

电化学发光法与液相色谱-串联质谱法评估糖尿病患者维生素D缺乏程度的效能比较与界值确定

于丹凤1,曹娟2,于世佳1,杜鲁涛3,侯新国1,4   

  1. 1.山东大学齐鲁医院内分泌与代谢病科, 山东 济南 250012;2.山东大学齐鲁医院健康管理中心, 山东 济南 250012;3.山东大学齐鲁医院检验医学中心, 山东 济南 250012;4.山东大学内分泌与代谢病研究所, 济南市内分泌与代谢病临床研究中心, 山东省医药卫生内分泌与代谢病重点实验室, 山东 济南 250012
  • 发布日期:2023-07-04
  • 通讯作者: 侯新国. E-mail:houxinguo@sdu.edu.cn
  • 基金资助:
    山东大学齐鲁医院2017年度新技术项目(2017-5)

Diagnostic capacity of electrochemiluminescence immunoassay compared with liquid chromatography-tandem mass spectrometry for vitamin D deficiency in diabetic patients

YU Danfeng1, CAO Juan2, YU Shijia1, DU Lutao3, HOU Xinguo4   

  1. 1. Department of Endocrinology, Qilu Hospital of Shandong University, Jinan 250012, Shandong, China;
    2. Department of Health Management Center, Qilu Hospital of Shandong University, Jinan 250012, Shandong, China;
    3. Department of Clinical Laboratory, Qilu Hospital of Shandong University, Jinan 250012, Shandong, China;
    4. Institute of Endocrine and Metabolic Diseases of Shandong University, Jinan Clinical Research Center for Endocrine and Metabolic Diseases, Key Laboratory of Endocrine and Metabolic Diseases, Shandong Province Medicine &
    Health, Jinan 250012, Shandong, China
  • Published:2023-07-04

PDF (PC)

188

摘要： 目的 对比电化学发光法(ECLIA)与液相色谱-串联质谱法(LC-MS/MS)检测糖尿病患者血清中25-羟基维生素D［25(OH)D］浓度结果的相关性与一致性,探讨ECLIA法诊断糖尿病患者维生素D缺乏程度的最佳诊断切点。 方法 收集209例住院糖尿病患者血清样本,分别采用LC-MS/MS法和ECLIA法检测25(OH)D浓度,以LC-MS/MS法为金标准,采用相关性分析、回归分析及一致性检验分析两种方法检测值的相关性和一致性,评估ECLIA法诊断维生素D缺乏程度的诊断效能,并利用受试者操作特征曲线(ROC)分别确定ECLIA法的最佳诊断切点。 结果 ECLIA法检测25(OH)D水平的中位数为18.88 ng/mL,LC-MS/MS法检测25(OH)D水平的中位数为14.61 ng/mL, 与LC-MS/MS法相比,ECLIA法结果呈正偏倚(26.402%),两者组内相关系数是0.531,两者相关系数rs=0.491(P<0.001),回归方程为YLC-MS/MS=-3.486+0.987XECLIA。以LC-MS/MS法检测值<20 ng/mL为维生素D缺乏的诊断标准时,ECLIA法检测值的ROC曲线下面积为0.78,以LC-MS/MS法检测25(OH)D浓度<10 ng/mL为维生素D严重缺乏的诊断标准时,ECLIA法检测值的ROC曲线下面积为0.69。通过ROC曲线分析,ECLIA法诊断维生素D缺乏的最佳切点为21.36 ng/mL,敏感度为74.48%,特异度为78.13%, Youden指数为0.53。ECLIA法诊断维生素D严重缺乏的最佳切点为16.68 ng/mL,敏感度为66.00%,特异度为70.44%,Youden指数为0.36。 结论 ECLIA法检测糖尿病患者血清25(OH)D的水平与LC-MS/MS法相比相关性较好,具有临床诊断价值,但ECLIA法测定值整体偏高,采用传统诊断切点会造成一定的临床漏诊率,建议在应用ECLIA法评估糖尿病患者维生素D缺乏程度时,以21.36 ng/mL作为维生素D缺乏的诊断切点,以16.68 ng/mL作为维生素D严重缺乏的诊断切点。

关键词: 液相色谱-串联质谱法, 电化学发光法, 25-羟维生素D, 糖尿病

Abstract: Objective To analyze the correlation and consistency between the results of liquid chromatography-tandem mass spectrometry(LC-MS/MS)and electrochemiluminescence immunoassay(ECLIA)for the determination of 25-hydroxyvitamin D(25(OH)D)concentration in the serum of diabetic patients, and to explore the optimal cutoff values of the two assays. Methods A total of 209 serum samples were collected from hospitalized diabetic patients, and 25(OH)D concentration was measured with LC-MS/MS and ECLIA, respectively. The correlation and consistency of 25(OH)D concentrations between the two methods were tested with correlation analysis, regression analysis, and consistency test. With LC-MS/MS as the gold standard to evaluate the diagnostic ability of ECLIA in diagnosing vitamin D deficiency, receiver operating characteristic(ROC)curve was used to determine the optimal cut-off value of ECLIA. Results The median concentration of 25(OH)D detected with ECLIA was 18.88 ng/mL, while that detected with LC-MS/MS was 14.61 ng/mL. Compared with LC-MS/MS, ECLIA showed a positive bias(26.402%). The correlation coefficient was 0.491(P<0.001), and the regression equation was YLC-MS/MS=-3.486+0.987XECLIA. The intraclass correlation coefficient was 0.531. The area under the ROC curve(AUC)using ECLIA was 0.78 when vitamin D deficiency was defined as <20 ng/mL, and the AUC was 0.69 when severe vitamin D deficiency was defined as <20 ng/mL. ROC curve analysis revealed that the optimal cut-off value of vitamin D deficiency was 21.36 ng/mL, with a sensitivity of 74.48%, specificity of 78.13%, and Youden index of 0.53. The optimal cut-off value of severe vitamin D deficiency was 16.68 ng/mL, with a sensitivity of 66.00%, specificity of 70.44%, and Youden index of 0.36. Conclusion A moderate correlation was demonstrated via 25(OH)D concentration detected with ECLIA and LC-MS/MS in diabetic patients, while serum 25(OH)D concentration measured with ECLIA was higher on average than that measured with LC-MS/MS, suggesting that 21.36 ng/mL should be used as the diagnostic cut-off value for vitamin D deficiency and 16.68 ng/mL for severe vitamin D deficiency in diabetic patients.

Key words: Liquid chromatography-tandem mass spectrometry, Electrochemiluminescence immunoassay, 25 hydroxyvitamin D, Diabetes

中图分类号: 

  • R587.1
[1] Prietl B, Treiber G, Pieber TR, et al. Vitamin D and immune function [J]. Nutrients, 2013, 5(7): 2502-2521.
[2] Wacker M, Holick MF. Vitamin D-effects on skeletal and extraskeletal health and the need for supplementation [J]. Nutrients, 2013, 5(1): 111-148.
[3] 中华医学会骨质疏松和骨矿盐疾病分会. 维生素D及其类似物临床应用共识[J]. 中华骨质疏松和骨矿盐疾病杂志, 2018, 11(1): 1-19.
[4] Sassi F, Tamone C, DAmelio P. Vitamin D: nutrient, hormone, and immunomodulator [J]. Nutrients, 2018, 10(11): E1656.
[5] Rosen CJ, Adams JS, Bikle DD, et al. The nonskeletal effects of vitamin D: an endocrine society scientific statement [J]. Endocr Rev, 2012, 33(3): 456-492.
[6] Autier P, Boniol M, Pizot C, et al. Vitamin D status and ill health: a systematic review [J]. Lancet Diabetes Endocrinol, 2014, 2(1): 76-89.
[7] Holick MF. The vitamin D deficiency pandemic: approaches for diagnosis, treatment and prevention [J]. Rev Endocr Metab Disord, 2017, 18(2): 153-165.
[8] 刘萍, 宋玉文, 王萍, 等. 维生素D缺乏与2型糖尿病合并抑郁状态的相关性[J]. 山东大学学报(医学版), 2021, 59(6): 51-56. LIU Ping, SONG Yuwen, WANG Ping, et al. Correlation between vitamin D deficiency and depression in patients with type 2 diabetes mellitus [J]. Journal of Shandong University(Health Science), 2021, 59(6): 51-56.
[9] Giustina A, Adler RA, Binkley N, et al. Consensus statement from 2nd international conference on controversies in vitamin D [J]. Rev Endocr Metab Disord, 2020, 21(1): 89-116.
[10] Song Y, Wang L, Pittas AG, et al. Blood 25-hydroxy vitamin D levels and incident type 2 diabetes: a meta-analysis of prospective studies [J]. Diabetes Care, 2013, 36(5): 1422-1428.
[11] Rasoul MA, Al-Mahdi M, Al-Kandari H, et al. Low serum vitamin-D status is associated with high prevalence and early onset of type-1 diabetes mellitus in Kuwaiti children [J]. BMC Pediatr, 2016, 16: 95.doi: 10.1186/s12887-016-0629-3.
[12] Cadario F, Prodam F, Savastio S, et al. Vitamin D status and type 1 diabetes in children: evaluation according to latitude and skin color [J]. Minerva Pediatr, 2015, 67(3): 263-267.
[13] Holick MF. Sunlight, UV-radiation, vitamin D, and skin cancer: how much sunlight do we need? [J]. Adv Exp Med Biol, 2008, 624: 1-15. doi:10.1007/978-0-387-77574-6_1.
[14] Hossein-Nezhad A, Holick MF. Vitamin D for health: a global perspective [J]. Mayo Clin Proc, 2013, 88(7): 720-755.
[15] Wacker M, Holick MF. Sunlight and vitamin D: a global perspective for health [J]. Dermato-Endocrinol, 2013, 5(1): 51-108.
[16] Cai Z, Zhang Q, Xia Z, et al. Determination of serum 25-hydroxyvitamin D status among population in southern China by a high accuracy LC-MS/MS method traced to reference measurement procedure [J]. Nutr Metab(Lond), 2020, 17: 8. doi: 10.1186/s12986-020-0427-7.
[17] Rahme M, Al-Shaar L, Singh R, et al. Limitations of platform assays to measure serum 25OHD level impact on guidelines and practice decision making [J]. Metabolism, 2018, 89: 1-7. doi:10.1016/j.metabol.2018.09.003.
[18] Mineva EM, Schleicher RL, Chaudhary-Webb M, et al. A candidate reference measurement procedure for quantifying serum concentrations of 25-hydroxyvitamin D3 and 25-hydroxyvitamin D2 using isotope-dilution liquid chromatography-tandem mass spectrometry [J]. Anal Bioanal Chem, 2015, 407(19): 5615-5624.
[19] Holick MF, Binkley NC, Bischoff-Ferrari HA, et al. Evaluation, treatment, and prevention of vitamin D deficiency: an endocrine society clinical practice guideline [J]. J Clin Endocrinol Metab, 2011, 96(7): 1911-1930.
[20] Han B, Wang X, Wang N, et al. Investigation of vitamin D status and its correlation with insulin resistance in a Chinese population [J]. Public Health Nutr, 2017, 20(9): 1602-1608.
[21] Liu W, Hu J, Fang Y, et al. Vitamin D status in Mainland of China: a systematic review and meta-analysis [J]. EClinicalMedicine, 2021, 38: 101017. doi:10.1016/j.eclinm.2021.101017.
[22] 李铮, 樊效菊, 韩睿. 维生素D与2型糖尿病: 从机制到临床应用[J]. 中华糖尿病杂志, 2017, 9(7): 465-468. LI Zheng, FAN Xiaoju, HAN Rui. Vitamin D and type 2 diabetes: from mechanism to clinical application[J]. Chinese Journal of Diabetes, 2017, 9(7): 465-468.
[23] Berridge MJ. Vitamin D deficiency and diabetes [J]. Biochem J, 2017, 474(8): 1321-1332.
[24] 郭叶丽, 章徐挺, 张小玲. 维生素D营养状况对2型糖尿病合并消化性溃疡患者幽门螺杆菌感染根除率的影响[J]. 中国慢性病预防与控制, 2022, 30(2): 138-141. GUO Yeli, ZHANG Xuting, ZHANG Xiaoling. Effect of vitamin D nutritional status on eradication rate of Helicobacter pylori infection in patients with type 2 diabetes mellitus complicated with peptic ulcer [J]. Chinese Journal of Prevention and Control of Chronic Diseases, 2022, 30(2): 138-141.
[25] Xiao Y, Wei L, Xiong X, et al. Association between vitamin D status and diabetic complications in patients with type 2 diabetes mellitus: a cross-sectional study in Hunan China [J]. Front Endocrinol(Lausanne), 2020, 11: 564738. doi:10.3389/fendo.2020.564738.
[26] Farah S, Yammine K. A systematic review on the efficacy of vitamin B supplementation on diabetic peripheral neuropathy [J]. Nutr Rev, 2022, 80(5): 1340-1355.
[27] Li X, Liu Y, Zheng Y, et al. The effect of vitamin D supplementation on glycemic control in type 2 diabetes patients: a systematic review and meta-analysis [J]. Nutrients, 2018, 10(3): 375.
[28] US Preventive Services Task Force, Krist AH, Davidson KW, et al. Screening for vitamin D deficiency in adults: us preventive services task force recommendation statement [J]. JAMA, 2021, 325(14): 1436-1442.
[29] van den Ouweland JM, Beijers AM, Demacker PN, et al. Measurement of 25-OH-vitamin D in human serum using liquid chromatography tandem-mass spectrometry with comparison to radioimmunoassay and automated immunoassay [J]. J Chromatogr B Analyt Technol Biomed Life Sci, 2010, 878(15/16): 1163-1168.
[30] Má cová L, Bi cíková M. Vitamin D: current challenges between the laboratory and clinical practice [J]. Nutrients, 2021, 13(6): 1758.
[31] Kocak FE, Ozturk B, Isiklar OO, et al. A comparison between two different automated total 25-hydroxyvitamin D immunoassay methods using liquid chromatography-tandem mass spectrometry [J]. Biochem Med(Zagreb), 2015, 25(3): 430-438.
[1] 李金泉,高美芳,闫飞,董明. 136例2型糖尿病患者肌肉痉挛的发生频率及危险因素[J]. 山东大学学报 (医学版), 2023, 61(5): 20-24.
[2] 张天鑫,张婷,黄鑫,韩佳沂,王淑康. 氨基酸与2型糖尿病因果关系的孟德尔随机化分析[J]. 山东大学学报 (医学版), 2023, 61(5): 102-107.
[3] 黄珊,娄能俊,韩晓琳,梁中昊,华梦羽,庄向华,陈诗鸿. 高糖环境下Lipin1对神经元代谢组学的影响[J]. 山东大学学报 (医学版), 2023, 61(2): 1-8.
[4] 宋宜耘,于慧,高兆丽,李宪花. 基于SIRT1/PGC-1α通路探讨葡萄籽原花青素提取物对糖尿病肾脏疾病大鼠的保护作用[J]. 山东大学学报 (医学版), 2023, 61(1): 1-9.
[5] 李涛,杨春林,杜通,李亨,王聪聪,李晓丽,段瑞生,张蓬. 糖尿病对重症肌无力NK细胞亚型及功能的影响[J]. 山东大学学报 (医学版), 2022, 60(5): 31-36.
[6] 唐钦连,张玉超,赵蕙琛,马小莉,于民民,刘元涛. 携带成对盒4基因突变早发糖尿病1例报道并文献复习[J]. 山东大学学报 (医学版), 2022, 60(5): 104-108.
[7] 赵美茹,朱迪,刘淋,管庆波,张栩. 简易胰岛素抵抗指标与698例2型糖尿病患者发生高尿酸血症风险的关联[J]. 山东大学学报 (医学版), 2022, 60(12): 44-51.
[8] 于书卷,王美娟,陈丽,曹英娟,吕晓燕,刘雪燕,林鹏,颜景政. 老年2型糖尿病患者轻度认知功能障碍的影响因素[J]. 山东大学学报 (医学版), 2022, 60(11): 108-112.
[9] 吕丽,姜璐,陈诗鸿,庄向华,宋玉文,王殿辉,安文娟,李倩,潘喆. 210例绝经后2型糖尿病发生骨质疏松的相关因素[J]. 山东大学学报 (医学版), 2021, 59(7): 19-25.
[10] 郑凤杰,宋玉文,孙爱丽,潘喆,王殿辉,娄能俊,吕丽, 庄向华,陈诗鸿. 糖尿病周围神经病变与肌少症的关联性[J]. 山东大学学报 (医学版), 2021, 59(6): 38-44.
[11] 刘萍,宋玉文,王萍,田光伟,郑凤杰,吕丽,杜娇娇,张静,庄向华,陈诗鸿. 维生素D缺乏与2型糖尿病合并抑郁状态的相关性[J]. 山东大学学报 (医学版), 2021, 59(6): 51-56.
[12] 萧阳,陶宇,王方怡,梁俞秀,张晋,季晓康,王志萍. 山东省部分地区PM2.5和PM10暴露与妊娠期糖尿病的关联性分析[J]. 山东大学学报 (医学版), 2021, 59(12): 101-109.
[13] 孔令群,王学文,王海滨,曹学峰,吴燕彬,张兴元. 副神经节瘤1例报告[J]. 山东大学学报 (医学版), 2020, 1(9): 110-112.
[14] 张宝文,雷香丽,李瑾娜,罗湘俊,邹容. miR-21-5p靶向调控TIMP3抑制2型糖尿病肾病小鼠肾脏系膜细胞增殖及细胞外基质堆积[J]. 山东大学学报 (医学版), 2020, 1(7): 7-14.
[15] 李林童,侯新国,秦君,梁凯,任建民. 青年人中的成年发病型糖尿病13型1例报道[J]. 山东大学学报 (医学版), 2020, 58(6): 71-75.
Viewed
Full text


Abstract

Cited
  Shared   
  Discussed   
No Suggested Reading articles found!
版权所有 © 2018 《山东大学学报(医学版)》编辑部　
地址:山东大学科技期刊社（济南市历城区山大南路27号山东大学中心校区明德楼B座721室） 电话: 0531-88366918 E-mail: xbyxb@sdu.edu.cn
本系统由北京玛格泰克科技发展有限公司设计开发