Wilson D H, Groskopf W, Hsu S, Caplan D, Langner T, Baumann M, DeManno D, Williams G, Payette D, Dagel C, Lynch D, Manderino G
Department of Fertility, Pregnancy, and Neurodiagnostics, AxSYM R&D, Abbott Laboratories, Abbott Park, IL 60064, USA.
Clin Chem. 1998 Jan;44(1):86-91.
We describe an automated assay for progesterone (P4) in human serum and plasma with the Abbott AxSYM random-access immunoassay analyzer. In this one-step competitive assay, P4 immobilized onto latex microparticles competes with sample P4 for binding to a conjugate of alkaline phosphatase (AP) and anti-P4 antibody. Total CVs ranged from 3.4% to 8.2% in multiple precision studies conducted according to the 20-day NCCLS EP5-T protocol. The detection limit (zero calibrator + 2 SD) was 0.10 microg/L across 36 experiments. Values for diluted samples were 83-116% of expected. Recovery of P4 added to serum specimens was 92-115%. Cross-reactivities with 43 natural and synthetic steroids were 0-6.3%. No significant interference was detected from bilirubin, protein, erythrocytes, hemoglobin, triglycerides, or cholesterol. In a multisite correlation study, AxSYM P4 results compared well with results from a commercial RIA method (n = 1156; r = 0.976; slope = 1.03; y-intercept = 0.04). Assay throughput is >80 tests per hour in batch mode, 60 tests per hour with mixed load list configurations.
我们描述了一种使用雅培AxSYM随机接入免疫分析分析仪检测人血清和血浆中孕酮（P4）的自动化检测方法。在这种一步竞争性检测中，固定在乳胶微粒上的P4与样本中的P4竞争结合碱性磷酸酶（AP）和抗P4抗体的结合物。根据20天的NCCLS EP5-T方案进行的多次精密度研究中，总变异系数范围为3.4%至8.2%。在36次实验中，检测限（零校准物+2标准差）为0.10μg/L。稀释样本的值为预期值的83 - 116%。添加到血清标本中的P4回收率为92 - 115%。与43种天然和合成类固醇的交叉反应率为0 - 6.3%。未检测到胆红素、蛋白质、红细胞、血红蛋白、甘油三酯或胆固醇的显著干扰。在一项多中心相关性研究中，AxSYM P4检测结果与一种商业放射免疫分析方法的结果相比良好（n = 1156；r = 0.976；斜率 = 1.03；截距 = 0.04）。在批量模式下，检测通量>80次测试/小时，在混合加载列表配置下为60次测试/小时。
