Journal of Shandong University (Health Sciences) ›› 2023, Vol. 61 ›› Issue (7): 90-95.doi: 10.6040/j.issn.1671-7554.0.2023.0078

• 临床医学 • Previous Articles    

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

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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

CLC Number: 

  • R587.1
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