Cosmi E V, Atlante G, Donadio C, Mariani L, Barbati A
Second Institute of Obstetrics and Gynecology, University La Sapienza, Rome, Italy.
Eur J Obstet Gynecol Reprod Biol. 1995 Jan;58(1):73-6. doi: 10.1016/0028-2243(94)01974-c.
This study was performed in order to evaluate and compare the serum CA 125 values obtained using an immunoradiometric (IRMA-II) and an immunoenzymatic (ETI-II) second generation assay, and to establish whether or not the two methods may be used interchangeably.
Serum CA 125 levels were measured in parallel using IRMA-II and ETI-II CA 125 assays (Sorin Biomedica), in 82 women with benign or malignant gynecological diseases. Statistical analysis was performed by linear regression analysis and Wilcoxon's test.
Serum CA 125 levels measured using the immunoenzymatic method were lower than those obtained by the immunoradiometric assay. The largest discrepancies between the two methods were found at concentrations of 35-100 U/ml, within which fall cutoff values for the immunoradiometric assay. The cutoff values of 35 or 65 U/ml, frequently used in the original immunoradiometric assay and retained for the immunoradiometric second generation assay, corresponded to 18 and 47 U/ml in the immunoenzymatic second generation assay.
The discrepancies in CA 125 results obtained by the two detection methods imply that the cutoff values used in the immunoenzymatic procedure should have a lower reference value in order to eliminate high rates of false negative results. Furthermore, their interchangeable use should be avoided in the monitoring of ovarian cancer and other gynecological diseases.
本研究旨在评估和比较使用免疫放射分析（IRMA-II）和免疫酶分析（ETI-II）第二代检测方法获得的血清CA 125值，并确定这两种方法是否可以互换使用。
使用IRMA-II和ETI-II CA 125检测方法（索林生物医学公司），对82例患有良性或恶性妇科疾病的女性并行测量血清CA 125水平。通过线性回归分析和威尔科克森检验进行统计分析。
使用免疫酶法测量的血清CA 125水平低于免疫放射分析获得的水平。两种方法之间的最大差异出现在35-100 U/ml的浓度范围内，免疫放射分析的临界值在此范围内。最初的免疫放射分析中常用的35或65 U/ml临界值，在免疫放射第二代检测中保留，在免疫酶第二代检测中分别对应于18和47 U/ml。
两种检测方法获得的CA 125结果存在差异，这意味着免疫酶检测中使用的临界值应具有较低的参考值，以消除高比例的假阴性结果。此外，在卵巢癌和其他妇科疾病的监测中应避免互换使用这两种方法。
