Department of Gastroenterology, Canary Islands Health System, University Hospital of Canary Islands, Ofra s/n, La Laguna, 38320, Santa Cruz de Tenerife, Spain.
J Gastroenterol. 2010 Jul;45(7):703-12. doi: 10.1007/s00535-010-0214-8. Epub 2010 Feb 17.
Immunochemical tests show important advantages over chemical-based faecal occult blood tests (FOBT) for colorectal cancer (CRC) screening, but comparison studies are limited. This study was performed to compare the accuracy of a sensitive immunochemical test with the guaiac test for detecting significant neoplasia (advanced adenomas and CRC) in an average-risk population.
A random sample of 2288 asymptomatic subjects 50-79 years of age was prospectively included. Participants received three cards of the guaiac test, one sample of a latex-agglutination test (haemoglobin cut-off 50 ng/ml), and an invitation to undergo colonoscopy. Test sensitivity, specificity, and positive and negative predictive values (PPV and NPV) were calculated in 1756 compliers.
Immunochemical and guaiac tests were positive in 143 (8.1%) and 62 (3.5%) subjects, respectively. Complete colonoscopy, performed in 402 participants (158 FOBT+ and 244 FOBT-), detected 14 (0.8%) patients with CRC and 49 (2.8%) with advanced adenomas. The immunochemical and guaiac tests for significant colorectal neoplasia showed sensitivities of 61% versus 23.8%, specificities of 95.1% versus 97.7%, PPVs of 43.4% versus 39.0%, and NPVs of 97.5% versus 95.4%, respectively. Proximal significant neoplasms were more frequently detected with the immunochemical test (85% vs. 15%) The relative risk for detecting significant neoplasia was superior in patients with a positive immunochemical test (RR 16.93; CI 7.94-36.10) than with a positive guaiac test (RR 3.34; CI 2.17-5.15).
A sensitive immunochemical test is markedly superior to the guaiac test for detecting significant colorectal neoplasia, and should be considered the first-choice FOBT for CRC screening in the average-risk population.
免疫化学检测在结直肠癌（CRC）筛查方面优于基于化学的粪便潜血检测（FOBT），但比较研究有限。本研究旨在比较敏感免疫化学检测与愈创木脂检测在一般风险人群中检测显著肿瘤（高级腺瘤和 CRC）的准确性。
前瞻性纳入了 2288 名年龄在 50-79 岁的无症状受试者的随机样本。参与者接受了三张愈创木脂检测卡、一份乳胶凝集检测（血红蛋白截断值为 50ng/ml）和结肠镜检查的邀请。在 1756 名依从者中计算了免疫化学和愈创木脂检测的敏感性、特异性、阳性和阴性预测值（PPV 和 NPV）。
免疫化学和愈创木脂检测阳性的分别有 143（8.1%）和 62（3.5%）例。在 402 名参与者（FOBT+ 158 例和 FOBT-244 例）中完成了完整的结肠镜检查，发现 14 例（0.8%）CRC 患者和 49 例（2.8%）高级腺瘤患者。免疫化学和愈创木脂检测对显著结直肠肿瘤的敏感性分别为 61%和 23.8%，特异性分别为 95.1%和 97.7%，PPV 分别为 43.4%和 39.0%，NPV 分别为 97.5%和 95.4%。免疫化学检测更常检测到近端显著肿瘤（85% vs. 15%）。与愈创木脂检测阳性患者相比，免疫化学检测阳性患者检测显著肿瘤的相对风险更高（RR 16.93；95%CI 7.94-36.10），而与愈创木脂检测阳性患者相比（RR 3.34；95%CI 2.17-5.15）。
敏感的免疫化学检测在检测显著结直肠肿瘤方面明显优于愈创木脂检测，应考虑作为一般风险人群 CRC 筛查的首选 FOBT。
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