光激化学发光免疫检测法测定TSH功能灵敏度的评价

The evaluation of detecting TSH functional sensitivity by light initiated chemiluminescent assay

目的采用光激化学发光免疫技术(LiCA)测定促甲状腺激素(TSH)项目的功能灵敏度。方法制备系列低浓度的TSH样本,使用LiCA对其进行检测。将待测样本分成10个批次,选用3个批号的TSH检测试剂,并进行3次校准,最终以批间变异系数(CV)=20%确定TSH项目的功能灵敏度,对其进行验证。结果 LiCA检测TSH项目的功能灵敏度验证值为0.018 mIU/L。结论 LiCA检测TSH项目的功能灵敏度能够达到美国国家临床生化学院(NCAB)的相关要求,有助于TSH项目实验室检测技术发展的需要。

Objective To detect the functional sensitivity of thyroid stimulating hormone （TSH） by light initiated chemiluminescent assay （LiCA）. Methods The samples with low concentrations of TSH were detected by LiCA. The samples were divided into 10 batches, and 3 batches of TSH reagents were used and calibrated for 3 times. As ultimately between-run coefficient of variation （CV） = 20%, the TSH functional sensitivity was verified. Results The functional sensitivity of TSH was 0. 018mlU/L by LiCA. Conclusions The functional sensitivity of TSH can meet the relevant standard of the National Academy of Clinical Biochemistry （NCAB） , and LiCA will help the need for laboratory testing technology improvement.