Eda S, Miyake K, Horii T, Igari J
Nippon Roche K.K., Diagnostics Division, Kamakura.
Rinsho Byori. 1995 Mar;43(3):257-62.
Latex photometric immunoassay for CA19-9 was clinically evaluated. Reference interval of the assay was determined as 37U/ml based on the data of 350 healthy donors. CA19-9 values were higher in females than in males (p < 0.01) and distribution of CA19-9 values varied significantly depending on the Lewis blood types of the subjects; namely, subjects with Lea+b- gave highest CA19-9 values followed by those with Lea-b+ and then those with Lea-b- (p < 0.001). In the patients with various malignant diseases, positive rates were high (> 60%) in the patients with pancreatic, hepatic, and colon cancer. Meanwhile, false positive rates were around 25-50% in the patients with pancreatitis, cholelithiasis, benign hepatic disorders and benign lung diseases. When cut-off value was set at 100U/ml, false positive rates decreased drastically, while true positive rates remained slightly decreased. These findings indicate that, in this latex assay, CA19-9 values of 100U/ml or higher should be regarded as high risk factor of malignancy and values in the range of > or = 37U/ml and < 100U/ml might be considered as warning signal of various benign and malignant diseases.
对CA19-9的乳胶免疫比浊法进行了临床评估。根据350名健康供者的数据，该检测方法的参考区间确定为37U/ml。女性的CA19-9值高于男性（p < 0.01），并且CA19-9值的分布根据受试者的Lewis血型有显著差异；即，Lea+b-型受试者的CA19-9值最高，其次是Lea-b+型，然后是Lea-b-型（p < 0.001）。在患有各种恶性疾病的患者中，胰腺癌、肝癌和结肠癌患者的阳性率较高（> 60%）。同时，胰腺炎、胆结石、良性肝脏疾病和良性肺部疾病患者的假阳性率约为25%-50%。当临界值设定为100U/ml时，假阳性率大幅下降，而真阳性率仍略有下降。这些结果表明，在这种乳胶检测中，100U/ml或更高的CA19-9值应被视为恶性肿瘤的高风险因素，而≥37U/ml且< 100U/ml范围内的值可能被视为各种良性和恶性疾病的警示信号。
