肿瘤标志物CA15-3的免疫放射分析及其临床应用  

Immunoradiometric assay of tumor marker CA15 3 and its clinical application

作　　者：陈智 周范振 符杨剑 许杨[1] 田征宇 

机构地区：[1]中国医学科学院中国协和医科大学肿瘤研究所肿瘤医院

出　　处：《中华肿瘤杂志》1998年第2期125-128,共4页Chinese Journal of Oncology

摘　　要：目的发展一项新的肿瘤标志物免疫放射分析，并初步评价其临床应用价值。方法从瑞典引进单克隆抗体Ｍａ５５２与Ｍａ６９５，以前者为扑捉抗体，后者为标记抗体，建立一种夹心式的免疫放射分析。将Ｍａ５５２包被于聚苯乙烯小珠上，并以１２５－Ｉ标记Ｍａ６９５单抗。测定为室温下的一步反应。结果标准曲线的Ｂｍａｘ／Ｂ０为８２。本测定的灵敏度为０．３Ｕ／ｍｌ；批内与批间ＣＶ分别为８％与１０％。５０名正常女性血清ＣＡ１５－３值为１１．３±３．９Ｕ／ｍｌ，若以３０Ｕ／ｍｌ为判别的界值，则假阳性率为０％。良性乳腺病４０例，ＣＡ１５－３值９．６±５．８Ｕ／ｍｌ，假阳性率０％。６５例不同病程阶段的乳腺癌患者，疗前血清ＣＡ１５－３水平为８８．４±１５９．６Ｕ／ｍｌ，总阳性率５０．８％。肝转移，特别是骨转移引起显著的血清ＣＡ１５－３升高，阳性率可达１００％（ｎ＝９）。乳腺癌复发的患者ＣＡ１５－３阳性率为８０％（ｎ＝５）。结论新建成的免疫放射分析在乳腺癌的诊断，鉴别诊断，监视转移和复发中有高度的临床应用价值，比ＣＥＡ更好。Objective To develop a new tumor marker immunoradiometric assay and to evaluate its preliminary clinical application. Methods With monoclonal antibodies Ma552 and Ma695 from Sweden, a sandwich immunoradiometric assay was developed with Ma552 as catching antibody and Ma695 as tracer. The Ma552 was coated on polystyrene beads, and Ma695 was labeled with 125 I. The reaction was one step at room temperature. Results Bmax/B0 of the standard curve was 82. The sensitivity of this assay was 0.3 u/ml, CV within assay and CV between assays were 8% and 10%, respectively. Serum level of CA 15 3 in 50 normal women was 11.3±3.9 u/ml with a false positive rate of 0% based on the cut off value of 30 U/ml. In 40 patients with benign breast diseases the serum level was 9.6± 5.8 u/ml with a false positive rate of 0%. In 65 cases of breast cancers in different stages it was 88.4± 159.6 u/ml before treatments with a total positive detection rate of 50.8%. Metastases, especially, bone metastases caused significant serum CA15 3 elevation, with 100% positive rate( n =9). The positive rate of recurrences of beast cancers was 80% ( n =5). Conclusion The newly established immunoradiometric assay of CA15 3 is highly useful in the diagnosis, differential diagnosis, and monitoring of metastases and recurrences of breast cancer, and is superior to CEA.

关 键 词：肿瘤标志物 免疫放射测定 CA15-3 抗原 乳腺癌 

分 类 号：R737.9[医药卫生—肿瘤]