Serum alpha-fetoprotein levels in human disease: perspective from a highly specific monoclonal radioimmunoassay.
Serum alpha-fetoprotein levels in human disease: perspective from a highly specific monoclonal radioimmunoassay.
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人类疾病中的血清甲胎蛋白水平：高度特异性单克隆放射免疫测定的视角。
DOI：
10.1073/pnas.81.12.3869
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发表时间：
1984
影响因子：
11.1
通讯作者：
Bohuon,C
中科院分区：
文献类型：
--
作者：
Bellet,DH;Wands,JR;Isselbacher,KJ;Bohuon,C
建立了一种快速多位点放射免疫分析法，用于测定人甲胎蛋白（AFP），该方法使用两种高亲和力的单克隆抗体，针对蛋白质上不同的和独立的决定簇，并命名为M-RIA。“夹心法”M-RIA的灵敏度在孵育1小时后约等于0.5 ng/ml血清。对1747例肝细胞癌（HCC）、急性和慢性B型肝炎病毒感染、慢性B型肝炎表面抗原（HBsAg）携带状态、肝硬化、其他恶性肿瘤、正常人和疾病对照者的血清AFP水平进行了测定，以确定该测定的特异性。80%（68/85）的HBsAg阳性HCC患者的AFP水平大于200 ng/ml（范围为260至大于200，000 ng/ml）。相比之下，所有450名正常受试者和477名慢性HBsAg阳性携带者的水平均低于20 ng/ml。更重要的是，在急性和慢性B型肝炎、肝硬化和其他恶性肿瘤以及其余疾病对照中，99.3%的受试者的AFP水平低于20 ng/ml，绝大多数（大于96%）低于5 ng/ml。事实上，1635人中只有两人，一人患有急性肝炎，另一人患有食道癌，AFP水平大于100 ng/ml。这些观察结果与之前的研究不同，这些研究采用传统多价RIA，在大约40%的急性和慢性肝炎以及30%的肝硬化中，AFP水平大于20 ng/ml。M-RIA的这种显著特异性可能部分是由于识别AFP特有的表位，并表明这种测定可用于检测、早期鉴定和监测高危人群中产生AFP的肿瘤。
A rapid multisite radioimmunoassay for measurement of human alpha-fetoprotein (AFP) that uses two high-affinity monoclonal antibodies directed against distinct and separate determinants on the protein was developed and designated M-RIA. The sensitivity of the "simultaneous-sandwich" M-RIA is approximately equal to 0.5 ng/ml of serum after a 1-hr incubation period. Serum AFP levels have been measured in 1747 individuals with hepatocellular carcinoma (HCC), acute and chronic hepatitis B virus infection, chronic hepatitis B surface antigen (HBsAg)-carrier states, cirrhosis, other malignant tumors, and normal and disease controls to determine the specificity of the assay. Eighty percent (68/85) of patients with HBsAg-positive HCC had AFP levels of greater than 200 ng/ml (range, 260 to greater than 200,000 ng/ml). In contrast, all 450 normal subjects and 477 chronic HBsAg-positive carriers had levels of less than 20 ng/ml. More importantly, in acute and chronic hepatitis B, cirrhosis, and other malignant tumors and in the remaining disease controls, AFP levels were less than 20 ng/ml in 99.3% of the subjects, the great majority (greater than 96%) being less than 5 ng/ml. Indeed only two of 1635 individuals, one with acute hepatitis and the other with carcinoma of the esophagus had AFP levels of greater than 100 ng/ml. These observations are at variance with previous studies with conventional polyvalent RIAs of AFP levels of greater than 20 ng/ml in approximately equal to 40% of acute and chronic hepatitis and in 30% of cirrhosis. This striking specificity of the M-RIA is probably due in part to recognition of epitopes unique to AFP and suggest that such an assay may be used in the detection, early identification, and monitoring of AFP-producing tumors in high-risk populations.