直接化学发光免疫法测定血清25羟基维生素D的性能验证  

Performance verification of direct chemiluminescence immunoassay to detect the serum 25-hydroxyvitamin D concentration

作　　者：高海丽 莫俊銮[2] 龚春梅[2] 杨慧[2] 陈燕媚 梁雄顺 徐远飞[2] 朱玉梅[2] 周继昌[2,3] 李鸣 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 Centerfor Chronic Disease Control,Shenzhen 518020,China;School of Public Health,Sun Yat-senUniversity( Shenzhen) ,Guangzhou 510006,China)

机构地区：[1]四川大学华西公共卫生学院,成都610041 [2]深圳市慢性病防治中心,深圳518020 [3]中山大学公共卫生学院(深圳),广州510006

出　　处：《卫生研究》2019年第4期633-637,共5页Journal of Hygiene Research

基　　金：深圳市卫生计生系统科研项目(No.SZGW2017010,SZGW2017015)

摘　　要：目的验证直接化学发光免疫法(CLIA)测定血清25羟基维生素D[25(OH)D]的性能。方法用意大利DiaSorin的CLIA分析仪测定美国国家标准技术研究院血清标准品(Nist SRM 972a)、DiaSorin质控品、维生素D检测质量外部评估计划盲样(DEQAS)和门诊人群血清中的25(OH)D浓度,测试该方法的功能灵敏度、精密度、准确度、回收率、线性等指标,并检测轻微溶血、4℃下储存5天和-80℃冻存1年以上的血清25(OH)D浓度。结果该法血清25(OH)D浓度检测的功能灵敏度<4 ng/mL,日内和日间相对标准偏差(RSD)<8.1%,仪器测量相对误差-3.1%~5.7%,回收率82.8%~112.9%,线性范围7.6~128.1 ng/mL;与新鲜血清相比,轻度溶血或4℃下储存5天对测定结果无影响(P<0.05);-80℃冻存1年以上,测定值平均降低7.6%。该方法与常见的几种方法相比,其测定结果的偏差为-2.9%~3.6%;3个不同单位间该方法精密度、准确度和回收率的差异较小。结论直接CLIA法测定血清25(OH)D的性能符合临床检验方法的基本技术要求,且简便、快速。OBJECTIVE To test the performance of direct chemiluminescence immunoassay(CLIA) in the determination of serum 25-hydroxyvitamin D [25(OH)D] concentration. METHODS 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. RESULTS 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. CONCLUSIONThe performance of direct CLIA for 25(OH)D assay meet the basic technical requirements for laboratory medicine, and is laborsaving and timesaving.

关 键 词：25羟基维生素D 直接化学发光免疫法 性能验证 血清检验 

分 类 号：Q565[生物学—生物化学] R446.1[医药卫生—诊断学]