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采用自动化免疫分析法测定血清总维生素 D(25-OH)与液相色谱串联质谱法的比较[校正]。

Measurement of serum total vitamin D (25-OH) using automated immunoassay in comparison [corrected] with liquid chromatography tandem-mass spectrometry.

机构信息

Department of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.

出版信息

J Clin Lab Anal. 2013 Jul;27(4):284-9. doi: 10.1002/jcla.21598.

Abstract

BACKGROUND

The associations of vitamin D deficiency with many nonskeletal diseases are still being discovered. We evaluated the use of an automated immunoassay to measure serum total vitamin D (25-OH) and assessed vitamin D status in a Korean adult population.

METHODS

We compared the Elecsys Vitamin D (25-OH) Total Assay (Roche Diagnostics) with liquid chromatography-tandem mass spectrometry (LC-MS/MS) using 300 serum samples. Total imprecision was calculated using three levels of quality control materials and serum samples. We also investigated the vitamin D status using data for 70,762 cases who had a routine health check-up in our hospitals.

RESULTS

The regression equation: Elecsys = 0.882 × LC-MS/MS + 6.814 (r = 0.926). Total imprecision was within 10% for all quality control materials and serum samples. The prevalence of vitamin D deficiency using cut-off values of <50 nmol/l (<20 ng/ml) were 70.3% in males and 86.4% in females, respectively. The prevalence of vitamin D deficiency was higher in younger subjects than in older subjects (P for linear-by-linear association was <0.001). Serum vitamin D levels were highest in September and lowest in February.

CONCLUSION

The Elecsys Vitamin D (25-OH) Total Assay was comparable to LC-MS/MS and appropriate for routine clinical use. Vitamin D deficiency is common in Korean adults.

摘要

背景

维生素 D 缺乏与许多非骨骼疾病的关联仍在不断被发现。我们评估了一种自动化免疫分析法来测量血清总维生素 D(25-OH),并评估了韩国成年人群的维生素 D 状况。

方法

我们使用 300 份血清样本比较了 Elecsys 维生素 D(25-OH)总测定法(罗氏诊断)与液相色谱-串联质谱法(LC-MS/MS)。使用三种质量控制材料和血清样本计算总不精密度。我们还使用了在我们医院进行常规健康检查的 70762 例病例的数据来研究维生素 D 状况。

结果

回归方程:Elecsys = 0.882 × LC-MS/MS + 6.814(r = 0.926)。所有质量控制材料和血清样本的总不精密度均在 10%以内。使用 <50 nmol/l(<20 ng/ml)的截断值,男性维生素 D 缺乏的患病率为 70.3%,女性为 86.4%。维生素 D 缺乏症在年轻受试者中的患病率高于老年受试者(线性线性关联的 P 值<0.001)。血清维生素 D 水平在 9 月最高,2 月最低。

结论

Elecsys 维生素 D(25-OH)总测定法与 LC-MS/MS 相当,适合常规临床使用。维生素 D 缺乏在韩国成年人中很常见。

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