MSACL 2016 US Abstract

Accuracy Evaluation of Routine Vitamin D Immunoassays Compared with LC-MS/MS in Pregnant Women and Intensive Care Unit Patients

Yeo-Min Yun (Presenter)
Konkuk University School of Medicine

Authorship: Yeo-Min Yun1, Hyun Jeong Kim1, Hee-Won Moon1, Mina Hur1, Junghan Song2
1Departments of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea; 2Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

Short Abstract

Serum samples of 160 healthy controls, 50 pregnant women, and 50 intensive care unit (ICU) patients were collected. Total 25(OH)D levels of each sample were measured by LC-MS/MS and three automated assays, including ADVIA Centaur (Siemens, Germany), Elecsys (Roche, Switzerland), and Architect i200SR (Abbott, US).The vitamin D results of all three routine immunoassays showed poor concordance compared with those of LC-MS/MS in ICU patients than those in healthy controls. In pregnant women, the vitamin D results of ADVIA Centaur showed the high positive bias compared with vitamin D values measured by LC-MS/MS. In conclusion, standardization of each immunoassays is essential for clinical use to estimate vitamin D status. Moreover, for the exact vitamin D status evaluation in ICU patients and pregnant women, using LC-MS/MS measurement would be recommended.

Long Abstract

Introduction: The associations of vitamin D and various clinical conditions have led to an increased importance in 25-hydroxyvitamin D [25(OH)D] assay. We can use several automated 25(OH)D assays including liquid chromatography/tandem mass spectrometry (LC-MS/MS) and immunoassay. We aimed to evaluate accuracy of three routine vitamin D immunoassays compared with the reference measurement using LC-MS/MS in pregnant women and intensive care unit (ICU) patients.

Methods: Serum samples of 160 healthy controls, 50 pregnant women, and 50 intensive care unit (ICU) patients were collected. Total 25(OH)D levels of each sample were measured by LC-MS/MS and three automated assays, including ADVIA Centaur (Siemens, Germany), Elecsys (Roche, Switzerland), and Architect i200SR (Abbott, US).

Results: In healthy control group (n=160), the mean absolute bias [(routine immunoassay result) - (LC-MS/MS results)] were -5.84 ng/mL (95% confidence interval [CI], -14.70 to 3.01 ng/mL) in ADVIA Centaur, 9.25 ng/mL (95% CI, -6.29 to 24.80 ng/mL) in Elecsys, and 3.51 ng/mL (95% CI, -10.64 to 17.67 ng/mL) in Architect. In ICU patient group (n=50), the mean absolute bias were 8.76 ng/mL (95% CI, -14.70 to 32.21 ng/mL) in ADVIA Centaur, ng/mL -7.17 mL (95% CI, -27.91 to 13.56 ng/mL) in Elecsys, and -6.37 ng/mL (95% CI, -27.43 to 14.69 ng/mL) in Architect. In Pregnant women (n=50), the mean absolute bias were 16.66 ng/mL (95% CI, 4.38 ~ 28.93 ng/mL) in ADVIA Centaur, 0.72 ng/mL (95% CI, -5.18 ~ 6.63 ng/mL) in Elecsys, and 1.54 ng/mL (95% CI, -4.50 ~ 7.57 ng/mL) in Architect.

Conclusions: The vitamin D results of all three routine immunoassays showed poor concordance compared with those of LC-MS/MS in ICU patients than those in healthy controls. In pregnant women, the vitamin D results of ADVIA Centaur showed the high positive bias compared with vitamin D values measured by LC-MS/MS. In conclusion, standardization of each immunoassays is essential for clinical use to estimate vitamin D status. Moreover, for the exact vitamin D status evaluation in ICU patients and pregnant women, using LC-MS/MS measurement would be recommended.


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