Serum level of cryptic tumor antigens in breast cancer patients as determined by two monoclonal antibodies (M85/F36) and its comparison with CA 15-3.
Serum level of cryptic tumor antigens in breast cancer patients as determined by two monoclonal antibodies (M85/F36) and its comparison with CA 15-3.
复制标题
两种单克隆抗体（M85/F36）测定乳腺癌患者血清隐性肿瘤抗原水平及其与CA 15-3的比较。
DOI：
10.1002/jcla.1860030502
复制
发表时间：
1989
影响因子：
2.7
通讯作者：
Nemoto,T
中科院分区：
文献类型：
--
作者：
Chu,TM;Constantine,R;Nemoto,T
采用双盲方式，在58名正常献血者、36名性别和年龄匹配的对照、36名良性乳腺疾病患者和47名乳腺癌患者的血清中，对一种测量乳腺癌粘蛋白样抗原（EMA-EIA）上隐藏表位的酶免疫测定系统进行了评价。在测定试剂盒的配置中使用两种鼠单克隆抗体，M85（IgM）作为固相，F36122（IgG 3）作为探针。该检测试剂盒还利用神经氨酸酶从碳水化合物侧链中去除末端唾液酸，以暴露血清标本中被掩蔽的隐蔽表位。来自正常健康献血者的EIA单克隆测定结果为17.34 ± 7.04单位/ml（平均值± 1 S.D.）正常上限为31.4单位/毫升在性别和年龄匹配的对照组（17.77 ± 11.17）和良性乳腺疾病组（14.34 ± 11.46）中，血清肌酐的分布与正常献血员相似。活动性乳腺癌患者和无疾病证据的乳腺癌患者的平均值分别为66.04单位/ml和27.74单位/ml，远高于正常人、对照组和良性乳腺疾病。同时分析正常供体和乳腺癌患者中的CA 15 - 3（一种假定的乳腺肿瘤标志物），显示相关回归分别为（CA 15 - 3）= 0.876（AUC）+ 1.972，r = 0.856;和（CA 15 - 3）= 0.66（AUC）+ 16.094，r = 0.730。这些数据表明，在正常献血者的标本中，CA 15 - 3和CA 15 - 3之间存在统计学显著相关性。然而，这种强烈的正相关性不能明确地建立在乳腺癌患者的标本。总之，对乳腺癌患者的双盲评价显示了该测定的可行性和临床潜力。与CA 15 - 3的有利比较令人鼓舞。此外，24个不同的配对和盲样获得了出色的重复性，支持了检测系统的技术可靠性。这些初步结果表明，乳腺癌是一个潜在的血清标志物参数。
An enzyme immunoassay system that measures cryptic epitopes on breast cancer mucinlike antigens (BCM‐EIA) was evaluated in a double‐blind manner in sera from 58 normal blood donors, 36 sex‐ and age‐matched controls, 36 patients with benign breast diseases, and 47 patients with breast cancer. Two murine monoclonal antibodies, M85 (IgM) as the solid‐phase and F36122 (lgG3) as the probe, were used in the configuration of the assay kit. The assay additionally utilized neuraminidase to remove terminal sialic acid from carbohydrate side‐chains to expose cryptic epitopes that were masked in serum specimens. BCM‐EIA monoclonal assay from the normal healthy blood donors resulted in 17.34 ± 7.04 units/ml (mean ± 1 S.D.) with an upper normal cutoff of 31.4 units/ml. The distributions of serum BCM in the sex‐ and age‐matched controls (17.77 ± 11.17) and benign breast diseases (14.34 2 11.46) were similar to that of normal blood donors. A mean value of 66.04 units/ml and 27.74 units/ml was obtained from breast cancer patients with active disease and without evidence of disease, respectively, a level much greater than those of normals, controls, and benign breast diseases. Simultaneous analysis of CA 15‐3, a putative breast tumor marker, in the normal donors and breast cancer patients revealed correlation regression of (CA 15‐3) = 0.876 (BCM) + 1.972, r = 0.856; and (CA 15‐3) = 0.66 (BCM) + 16.094, r = 0.730, respectively. These data showed that there is a statistically significant correlation of CA 15‐3 and BCM in normal blood donors' specimens. However, such a strong and positive correlation canot be unequivocally established in breast cancer patients' specimens. In conclusion, the double‐blind evaluation of breast cancer patients revealed the feasibility and clinical potential of the assay. The favorable comparison of BCM with CA 15‐3 was encouraging. In addition, an excellent repeatability was obtained by 24 different paired and blind specimens supporting the technical reliability of the assay system. These initial results demonstrated that BCM is a potential serum marker parameter for breast cancer.