The Constraction And Clinical Application Of The Microcolumn Gel Immunodetection System In The Serum Tumor Marker-CA125 Of Ovarian Malignant Tumor

Ovarian malignant tumor is one of common tumor in department of gynecology, and the fatality is in the first place of womens'malignant tumor. As the shortens of reliable test methods, most patients (75%) are diagnosed in their later stage (III or IV), the 5-year survival ratio is less than 50%. So, diagnosis of the malignant tumor of ovary in the early stage has significant importance in decreasing fatality of the patients. Microcolumn gel test, a new test technology used extensively in many haematogenic immunity studio among many developed countries. The gel test replaces many traditional methods in testing the Ag-Ab of RBC, microcolumn gel test is used extensively in many aspects, such as the ABO blood type, detecting irregular Ab in serum, detecting the platelet Ab and it's application in crossmatching of blood, nevertheless, there are no reports related to the application of microcolumn gel Coombs test in detecting tumor marker of ovarian cancer. This research refers the basic principles of microcolumn gel test, making reaction between the CA125IgG&marked-RBC and Ag of the serum of patients, if the Ag-Ab uncompatible, the marked-RBS would sediment in the cube, act as the negative reaction, on the contrary, the marked-RBC would attach to the cliff of the cube instead of sedimentation. The characteristics of this method is simply, standardablelization, automatization, repeatability, six cubes in one card, reduced marker, avoid mistakes, little samples, without cleaning, stable results, easy to read, and so on. Besides, the microcolumn gel test card can detect many malignant ovary tumor markers in one time, enhance the effect of detect. This research sets the chemiluminescence analysis method as the control group, to analyses the effect of microcolumn gel est in detecting the CA125 in the serum of patients with malignant ovary tumor. Hopefully, under this technology we can screen and diagnosis the patients with malignant ovary tumor in the early stage and well done in the following-up.Objective: To investigate the clinical practice of microcolumn gel test in detecting the serum tumor markers of ovarian malignant tumor.Method:In this test, we detect the positive ratio of the serum tumor marker- CA125 of 110 cases of ovarian malignant tumor with the chemiluminescence immunoassay and microcolumn gel est respectively, set the chemiluminescence immunoassay as the control group. The qualitative research is under the microcolumn gel test. We collect 3ml blood sample randomly of the each patients, collect the serum from the samples after centrifugalization, make the mark RBC and a piece of microcolumn gel test card. Add the diluted CA125 antibody(1:200) 50ul and the serum of subjects 50uL into each of the tube respectively, incubation, then add the marker RBC 50ul, read the result after centrifugalization. Analyzing the result with the double-Ab sandwich method automatically, the machine aspirates 50ul specimen, 50ul liquid agent,250ul solid agent,then incubated 7.5min at the temperature of 37℃,washing the complex,adding reaction agent(alkaline H2O2) to provocate the reaction, the light intense is correlated to the concentration of the sample.We set the result>35U/ml as the positive value.Results: we useχ2 test to compare the difference of the positive ratio between these two methods, and analyze the correlation of these two methods.The positive ratio of the 15 normal patients,25 ovarian benign tumor,30 borderline ovarian tumors,110 epithelial ovarian cancer is 13.3%,24%,30%,80% of the microcolumn gel test respectively;sensitivity is 80%,specificity is 75.7%,positive predictive value is 83.8%,Negative predictive value 70.7%;and with applicationg of chemiluminescence immunoassay ,the positive ratio respectively is 26.7%,28%,36.7%,83.3%; sensitivity is 83.3%,specificity is 68.6%,positive predictive value is 80.7%,Negative predictive value 72.7%.Conclusions: With using the microcolumn gel coombs test and chemiluminescence immunoassay test,the masculine expression ratio of CA125 is respectively lower in normal women,borderline ovarian tumors,ovarian benign compare to epithelial ovarian cancer;indicating that epithelial ovarian cancer is a tumor where serum tumor marker-CA125 higly expression.CA125 positive expression ratio has relation with histology type and clinical stage , the microcolumn gel test and chemiluminescence immunoassay test has correlation , the microcolumn gel testis not only suit to test CA125 but also can test many kinds of tumor markers ,to raise masculine detection ratio of ovarian cancer ,we can make combination of many kinds of tumor marker through these investigation, although the microcolumn gel test just can quantitate the CA125 of the ovarian tumor, it is a convenient and rapid method for the clinical, especially for the community clinic and the basic hospital in the scanning of the ovarian tumor. the microcolumn gel test not only can test the quantity of the CA125, but also can detect many tumor maker in the serum, so it can increase the detection rate of ovarian malignant tumor.