血清孕酮放射免疫测定试剂盒的研制

PREPARATION OF A RADIOIMMUNOASSAY KIT FOR HUMAN SERUM PROGESTERONE

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 a specific antibody for human Progesterone radioimmunoassay kit, specific anti-P antibodies were obtained by immunizing rabbits with chemically conjugated P-11α-HS-BSA. Progesterone was labelled with choloramine-T(Cl-T), then purified with TCL. Serum was purified from human hormone and a method of competitive binding assay was established. Through methodology study and realiability test, the high sensitivity, speeificfty and accuracy were confirmed in this methed ( relativity= 0.996 ). The mean serum progesterone value was in 50 healthy male subjects 0-1.85ng/ml. In healty women, the follicular phase value was 0.14-1.65ng/ml, luteal phase was 2.07-32ng/ml and menopause phase was o.2-1.7ng/ml. In normal pregnancies, levels of progesterone increased with duration of gestation up to 280ng/ml. The kit was found to be clinically applicable as related to its stability, reliability and sensitivity.