糖类抗原CA72-4化学发光定量免疫分析方法的建立

Quantitative Chemiluminescence Immunoassay for Carbohydrate Antigen 72-4

目的建立糖类抗原CA72-4化学发光定量免疫测定方法。方法一株抗CA72-4单克隆抗体经微孔板固相包被与另一株酶标单克隆抗体建立双夹心反应体系,检测样品中CA72-4抗原的含量。通过与国外权威试剂盒血样测值的对比,分析该方法临床应用的可行性。结果该分析方法线性范围为0~160 U/m L,灵敏度为0.55U/m L。批内CV值为:5.49%,4.53%;批间CV值为:8.12%,7.81%;回收率为:99.74%~104.11%;与CEA,CA125,CA19-9无交叉反应;与法国Cisbio analysis公司所生产的CA72-4免放药盒血清测值对比分析后,发现两者相关性较高,并确定了本分析方法的正常范围。结论该分析方法的测定结果与参比试剂盒结果有较高符合率,可用于临床血清中CA72-4的检测。

Objective To establish a quantitative chemiluminescence immunoassay for Carbohydrate Antigen72-4（ CA72-4）. Methods A double antibody sandwich system was developed by using two types of antiCA72-4 M c Abs,which were microplate coated and horseradish peroxidase（ HRP） labeled to detect CA72-4on clinical samples. The diagnostic value of this method was compared with the other reliable kit. Results The standard range of this method was 0 ~ 160 U/m L. The assay sensitivity was 0. 55 U/m L. The intra-and inter-assay coeffients of variance were 5. 49%,4. 53% and 8. 12%,7. 81%,respectively. Analytical recovery was 99. 74% ~ 104. 11% and no cross-reaction with CEA,CA125 or CA19-9 was detected.Compared the results of clinical samples with an immunoradiometric kit from Cisbioanalysis company,a high correlation coefficient was reached. The method also provided a positive value for reference only. Conclusion The quantitative chemiluminescence immunoassay for Carbohydrate Antigen 72-4 provides a reliable method,which can be used in clinical detection of CA72-4.