摘要
目的基于光激化学发光技术平台初步建立血清催乳素(PRL)的分析方法,并评估其性能指标。方法将发光纳米微球和生物素分别标记于一对人PRL单抗,两者与血清中待检PRL、链霉亲合素标记的感光微球(通用感光溶液)在均相条件下形成双抗体夹心的检测体系,对该检测体系的性能指标和相关性进行评价。结果本方法的批内变异系数和日间变异系数分别为4.60%和5.25%;功能灵敏度为2.48μIU/mL,可报告范围为2.48~4 240μIU/mL;回收试验加入浓度为42.2、424、4 240μIU/mL PRL标准品时的回收率为96.25%~102.93%;胆红素<20 mg/dL、血红蛋白<200 mg/dL、三酰甘油<3 000 mg/dL、生物素<20 ng/mL时,均无干扰现象发生;该方法与贝克曼Unicel Dxi 800 Access 2增强化学发光酶免疫分析法具有良好的相关性。结论光激化学发光法检测血清PRL的方法具有良好的分析性能,可满足临床诊断需求。
Objective To establish an analytical method for serum prolactin(PRL) based on the photoinduced chemiluminescence technology, and evaluate its performance. Methods A pair of PRL monoclonal antibodies were labeled with luminescent nanospheres and biotin respectively, and the double antibody sandwich detection system was formed with the serum prolactin and streptavidin-labeled photosensitive microspheres(universal photosensitive solution) under homogeneous conditions. The performance index and correlation of the detection system were evaluated. Results The precision of intra-assay and within-day(coefficient of variation) of the developed assay were 4.60% and 5.25%, respectively. The functional sensitivity was 2.48 μIU/mL, and its reportable results were ranged from 2.48 to 4 240 μIU/mL. The recovery rates of different PRL calibrators(42.2, 424, 4 240 μIU/mL) added to human sera were ranged from 96.25% to 102.93%. There was no interference from bilirubin<20 mg/dL, hemoglobin<200 mg/dL, triglyceride<3 000 mg/dL and biotin<20 ng/mL. Also, the light-initiated chemiluminescent assay for PRL(PRL-LICA) correlated well with Beckman Unicel Dxi 800 Access 2. Conclusions LICA showed effective performance for detecting PRL in human serum, and it could meet the basic requirements of clinical diagnosis.
作者
任杰
刘胜林
李会强
REN Jie;LIU Shenglin;LI Huiqiang(Department of Clinical Laboratory, Xiqing Hospital of Tianjin, Tianjin 300380;School of Medical Laboratory, Tianjin Medical University, Tianjin 300203, China)
出处
《临床检验杂志》
CAS
2019年第7期495-498,共4页
Chinese Journal of Clinical Laboratory Science
关键词
催乳素
光激化学发光分析
均相免疫分析
prolactin
light initiated chemiluminescent assay
homogeneous immunoassay