Chen Z, Fan Z, Yang J
Cancer Institute (Hospital), Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing.
Zhonghua Zhong Liu Za Zhi. 1998 Mar;20(2):125-8.
To develop a new tumor marker immunoradiometric assay and to evaluate its preliminary clinical application.
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.
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).
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.
开发一种新的肿瘤标志物免疫放射分析方法并评估其初步临床应用。
采用来自瑞典的单克隆抗体Ma552和Ma695，以Ma552为捕获抗体、Ma695为示踪剂建立夹心免疫放射分析方法。将Ma552包被在聚苯乙烯珠上，Ma695用125-I标记。反应在室温下一步完成。
标准曲线的Bmax/B0为82。该分析方法的灵敏度为0.3 u/ml，批内变异系数和批间变异系数分别为8%和10%。50名正常女性的血清CA 15-3水平为11.3±3.9 u/ml，以30 U/ml为临界值时假阳性率为0%。40例乳腺良性疾病患者的血清水平为9.6±5.8 u/ml，假阳性率为0%。65例不同分期乳腺癌患者治疗前血清水平为88.4±159.6 u/ml，总阳性检出率为50.8%。转移，尤其是骨转移导致血清CA15-3显著升高，阳性率为100%（n = 9）。乳腺癌复发阳性率为80%（n = 5）。
新建立的CA15-3免疫放射分析方法在乳腺癌的诊断、鉴别诊断以及转移和复发监测中非常有用，且优于癌胚抗原（CEA）。
