Gao Haili, Mo Junluan, Gong Chunmei, Yang Hui, Chen Yanmei, Liang Xiongshun, Xu Yuanfei, Zhu Yumei, Zhou Jichang, Li Ming
West China School of Public Health, Sichuan University, Chengdu 610041, China.
Shenzhen Center for Chronic Disease Control, Shenzhen 518020, China.
Wei Sheng Yan Jiu. 2019 Jul;48(4):633-637.
To test the performance of direct chemiluminescence immunoassay(CLIA) in the determination of serum 25-hydroxyvitamin D [25(OH)D] concentration.
The CLIA analyzer of Italy DiaSorin was used to measure the 25(OH)D concentrations in the Standard Reference Material 972 a of National Institute of Standards and Technology, DiaSorin control materials, blind samples of Vitamin D External Quality Assessment Scheme(DEAQS), and outpatient serum samples. The functional sensitivity, precision, accuracy, recovery, and linearity were evaluated, and the samples of mild hemolysis, 5 days' storage at 4 ₿ and >1 year's storage at-80 ₿were tested for 25(OH)D.
The functional sensitivity was<4 ng/mL. The coefficient of variations of intra-and inter batch were<8. 1%. The relative deviation was-3. 1%-5. 7%. The recovery rates were 82. 8%-112. 9% and it had good linearity in the range of 7. 6-128. 1 ng/mL. Compared with fresh serum, the serum 25(OH)D concentration was not affected by mild hemolysis or being stored at 4 ₿for 5 days, but averagely decreased at 7. 6% by being stored at-80 ₿for more than 1 year. Compared with others, the deviation was-2. 9%-3. 6%. The differences in precision, accuracy and recovery of this method among the three different hospitals is slightly.
The performance of direct CLIA for 25(OH)D assay meet the basic technical requirements for laboratory medicine, and is laborsaving and timesaving.
检测直接化学发光免疫分析法（CLIA）测定血清25-羟基维生素D[25(OH)D]浓度的性能。
采用意大利索灵公司的CLIA分析仪检测美国国家标准与技术研究院的标准参考物质972a、索灵质控品、维生素D室间质量评价计划（DEAQS）的盲样以及门诊患者血清样本中的25(OH)D浓度。评估其功能灵敏度、精密度、准确度、回收率和线性，并对轻度溶血样本、4℃保存5天及-80℃保存1年以上的样本进行25(OH)D检测。
功能灵敏度<4 ng/mL。批内和批间变异系数<8.1%。相对偏差为-3.1%-5.7%。回收率为82.8%-112.9%，在7.6-128.1 ng/mL范围内线性良好。与新鲜血清相比，血清25(OH)D浓度不受轻度溶血或4℃保存5天的影响，但-80℃保存1年以上平均降低7.6%。与其他方法相比，偏差为-2.9%-3.6%。该方法在三家不同医院的精密度、准确度和回收率差异较小。
直接CLIA法检测25(OH)D的性能符合检验医学的基本技术要求，且省时省力。
