血清催乳素光激化学发光法的建立及性能评价

Establishment and performance evaluation of light-initiated chemiluminescent assay for quantitation of prolactin in human serum

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.