Overholt Bergein F, Wheeler Donald J, Jordan Tommye, Fritsche Herbert A
Gastrointestinal Associates, Knoxville, Tennessee, USA.
MD Anderson (retired), Houston, Texas, USA.
Gastrointest Endosc. 2016 Mar;83(3):545-51. doi: 10.1016/j.gie.2015.06.041. Epub 2015 Aug 28.
Colorectal cancer (CRC) remains the second most frequent cause of cancer deaths in the United States. Blood tests using tumor-related antigens aid in diagnosing CRC. However, higher sensitivity and specificity are needed before an acceptable tumor antigen blood test for CRC is clinically useful. This study describes the diagnostic accuracy of an enzyme-linked immunosorbent assay for the CA11-19 serologic tumor antigen for the detection of CRC.
Serum specimens were obtained from 522 colonoscopy-confirmed subjects in institutional review board-approved studies. Specimens were blind coded. CA11-19 levels were determined by using enzyme-linked immunosorbent assay analysis. The results were tabulated for categories of normal, hyperplastic polyps, benign GI, adenomatous polyps, and CRC based on their final diagnosis.
When a cutoff of 6.4 units/mL for normal is used, the CA11-19 level was elevated in 128 of 131 of CRC subjects, for an observed sensitivity of 98% (95% confidence interval, 93.1%-99.5%). Normal levels were found in 87% of normal subjects (90/103) and 83% of those with benign GI diseases (185/223). When combined, this yields an observed specificity of 84% (95% confidence interval, 80.0%-87.9%).
CA11-19 is a serologic tumor marker for the diagnosis of CRC with a sensitivity of 98% and specificity of 84%. This high sensitivity means that this test will detect 43 of 44 cases of CRC presented. For those older than 50 years of age, it has a positive predictive value of 3.6% and a negative predictive value of 99.98%. Additional prospective studies are needed to further clarify the use of CA11-19 as an aid in the diagnosis of CRC.
在美国，结直肠癌（CRC）仍是癌症死亡的第二大常见原因。使用肿瘤相关抗原的血液检测有助于诊断CRC。然而，在一种可接受的用于CRC的肿瘤抗原血液检测具有临床实用性之前，还需要更高的灵敏度和特异性。本研究描述了一种用于检测CRC的CA11 - 19血清学肿瘤抗原的酶联免疫吸附测定的诊断准确性。
在机构审查委员会批准的研究中，从522名经结肠镜检查确诊的受试者中获取血清标本。标本进行盲编码。使用酶联免疫吸附测定分析来确定CA11 - 19水平。根据最终诊断，将结果按正常、增生性息肉、良性胃肠道疾病、腺瘤性息肉和CRC类别进行列表。
当正常临界值设定为6.4单位/毫升时，131例CRC受试者中有128例CA11 - 19水平升高，观察到的灵敏度为98%（95%置信区间，93.1% - 99.5%）。87%的正常受试者（90/103）和83%的良性胃肠道疾病患者（185/223）CA11 - 19水平正常。综合起来，观察到的特异性为84%（95%置信区间，80.0% - 87.9%）。
CA11 - 19是一种用于诊断CRC的血清学肿瘤标志物，灵敏度为98%，特异性为84%。这种高灵敏度意味着该检测将能检测出所呈现的44例CRC病例中的43例。对于年龄超过50岁的人群，其阳性预测值为3.6%，阴性预测值为99.98%。需要进一步的前瞻性研究来进一步阐明CA11 - 19在辅助诊断CRC中的应用。
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