Establishment and performance evaluation of light-initiated chemiluminescent assay for quantitation of prolactin in human serum / 临床检验杂志

ABSTRACT

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.