The development of a new diagnostic method for uterine endometrial cancer, using monoclonal antibody for glicolipids, and its application for mass screening

我们用抗子宫癌单抗MSN-1用酶免疫分析法(EIA)检测了子宫内膜细胞样本中“MSN-1”抗原(主要是Lewis^b糖链)的水平。我们建立了一种新的子宫内膜癌诊断方法EMC-EIA，根据MSN-1抗原水平的定量差异来区分正常子宫内膜细胞和癌细胞，并对原有的EMC-EIA方法进行了改进。由于样品可以长期保存，而且程序简单，这种EMC夹心EIA方法很容易制成试剂盒。它的临床适用性得到了大量临床样本的证实。EMC夹心EIA方法包括在子宫内膜细胞学诊断后，将附着在样本采集装置上的残留细胞用表面活性剂增溶。肌动蛋白(蛋白质含量)和MSN-1的主要抗体结合在一个微滴定板上。随后，Msn-1抗…的量通过使用酶标记的MSN-1和抗肌动蛋白抗体的夹心EIA测量细胞样本中每单位蛋白质更多的n。我们调查了48例正常子宫内膜、11例子宫内膜增生症和45例子宫内膜癌组织。正常子宫内膜阳性率为4.2%，子宫内膜增生症阳性率为45.5%，子宫内膜癌阳性率为66.7%。高分化子宫内膜腺癌的阳性率为76%，具有特别高的价值。对35例子宫癌患者同时行细胞学诊断和EMC夹心EIA的研究中，细胞诊断的阳性率为63.3%，EMC夹心EIA的阳性率为63.3%，两者联合应用的阳性率为83.3%。结论：EMC夹心EIA可作为子宫癌，特别是高分化腺癌的辅助诊断方法。由于该方法具有试剂盒应用等多种特点，因此也可用于筛选。较少

We measured the levels of the "MSN-1" antigen (mainly the Lewis^b sugar chain) in endometrial cell samples using an enzyme immunoassay (EIA) with the anti-uterine cancer monoclonal antibody MSN-1. We developed a new diagnostic EmC-EIA (Endometrial Cell Enzyme Immunoassay) method for endometrial cancer which enabled distinction between normal endometrial cells and cancer cells according to quantitative differences in the level of MSN-1 antigen.The original EmC-EIA method was also improved. Since long term storage of samples is possible and the procedure is simple, this EmC sandwich EIA method could easily be made into a kit. Its clinical applicability was confirmed using many clinical samples. The EmC sandwich EIA method involves solubilization with surfactant of the residual cells adhering to the sample collection device after endometrial cytodiagnosis. The primary antibodies for actin (protein content) and MSN-1 are bound to a microtiter plate. Subsequently, the amount of MSN-1 antige … More n per unit protein in the cell sample is measured by a sandwich EIA using enzme-labeled MSN-1 and antiactin antibodies. We investigated 48 samples of normal endometrium, 11 of endometrial hyperplasia, and 45 of endometrial cancer. The positive rate (when the mean +2 SD for normal endometrium was taken as the cut-off value) was 4.2% for normal endometrium, 45.5% for endometrial hyperplasia, and 66.7% for endometrial cancer. The positive rate was 76% for well-differentiated endometrial adenocarcinoma, a particularly high value. In a study of 35 patients with uterine cancer who underwent both cytodiagnosis and the EmC sandwich EIA,the positive rate was 63.3% for cytodiagnosis and 63.3% for the EmC sandwich EIA.However, when the two methods were combined, the positive rate rase 83.3%.In conclusion, the EmC sandwich EIA was found to be useful as a auxiliary procedure to cytodiagnosis in patients with uterine cancer, especially those with well-differentiated adenocarcinoma which is often hard to evaluate by cytodiagnosis. Since this assay has various features such as application as a kit, it could also be used for screenig. Less