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制备人孕酮放射免疫试剂盒的特异性抗血清,首先要合成孕酮-11α-半琥珀酰-BSA结合物,形成完全抗原,依据动物体的免疫反应规律,制备高质量的抗孕酮抗血清。采用氯胺T法标记孕酮;TCL分离。制备去人激素血清,建立了竞争结合分析法。通过方法学和可靠性的测定,说明该方法具有较高的灵敏度、特异性、准确性,相关系数r=0.996。检测了50名正常中、青年男子,测定值为0～1.85ng/ml,正常女性范围:滤泡期为0.14～1.65ng/ml,黄体期2.07～32ng/ml,绝经期0.2～1.7ng/ml,妊娠期:随着妊娠月份的增加,孕酮浓度也增加,最高可达280ng/ml。经临床验证,该试剂盒符合稳定、可靠、灵敏、适用的要求。
To prepare the specific antiserum of human progesterone radioimmunoassay kit, firstly, progesterone-11α-hemosuccinyl-BSA conjugate should be synthesized to form the complete antigen, and according to the law of immune reaction of animal body, high-quality antiprogestin serum. Progesterone was labeled with chloramine T method; TCL was separated. Preparation of human hormone serum, the establishment of a competitive binding assay. Through the methodological and reliability determination, the method has high sensitivity, specificity and accuracy, the correlation coefficient r = 0.996. A total of 50 normal middle-aged and young men were tested, with a range of 0-1.85ng / ml. The normal range of women was: follicular phase 0.14-1.65ng / ml, luteal phase 2.07-32ng / ml, menopause 0.2-1.7ng / ml, during pregnancy: with the increase of the month of pregnancy, progesterone concentration also increased, up to 280ng / ml. The clinical validation, the kit is consistent with stable, reliable, sensitive and applicable requirements.