Registre Bourguignon des Cancers Digestifs, INSERM U866, Université de Bourgogne, 7 boulevard Jeanne d'Arc, Dijon Cedex, France.
Eur J Cancer. 2013 Aug;49(12):2727-33. doi: 10.1016/j.ejca.2013.03.023. Epub 2013 Apr 16.
Quantitative immunochemical faecal occult blood tests have become the recommended tests for colorectal cancer screening. The aim of this study was to complete our knowledge on the performance of one of the quantitative immunochemical tests available, FOB-Gold, and to propose a possible strategy for an organised screening programme.
Within the French organised screening programme, 23,231 average-risk individuals, aged 50-74 performed both a 3-day Hemoccult test and a 1-day FOB-Gold test. Performances of the immunochemical test were evaluated at different cut-off levels.
The positivity rate for the Hemoccult was 2.1% and for the FOB-Gold varied between 4.6% (cut-off value of 100 ng/mL, the lowest studied cut-off) and 2.1% (cut-off value of 352 ng/mL). The number of colonoscopies decreased with increasing cut-off values by 21.5% (150 ng/mL), 35.4% (200 ng/mL) and 53.3% (352 ng/mL). The corresponding miss rate for CRC was respectively 6.4%, 11.1% and 22.2%, and for advanced adenoma respectively 16.3%, 29.2% and 43.6%. Compared with the reference cut-off for the FOB-Gold (100 ng/mL) the miss rate for Hemoccult was 53% for CRC and 77% for advanced adenoma.
The study suggests that in countries with colonoscopy facilities compatible with a screening test positivity rate of up to 5%, use of a 1-day test with a cut-off value between 100 and 150 ng/mL could be the recommended strategy. Further increasing the cut-off value up to the same positivity rate as Hemoccult could be used in areas with limited access to colonoscopy.
定量免疫化学粪便潜血试验已成为结直肠癌筛查的推荐检测方法。本研究旨在进一步了解可用的定量免疫化学检测方法之一 FOB-Gold 的性能，并提出一种用于有组织筛查计划的可能策略。
在法国有组织的筛查计划中，23231 名平均风险的 50-74 岁个体同时进行了 3 天 Hemoccult 检测和 1 天 FOB-Gold 检测。评估了免疫化学检测的不同临界值水平的性能。
Hemoccult 的阳性率为 2.1%，FOB-Gold 的阳性率在 4.6%（最低研究的临界值 100ng/mL）和 2.1%（临界值 352ng/mL）之间变化。随着临界值的升高，结肠镜检查的数量分别减少了 21.5%（150ng/mL）、35.4%（200ng/mL）和 53.3%（352ng/mL）。CRC 的相应漏诊率分别为 6.4%、11.1%和 22.2%，高级腺瘤分别为 16.3%、29.2%和 43.6%。与 FOB-Gold 的参考临界值（100ng/mL）相比，Hemoccult 对 CRC 的漏诊率为 53%，对高级腺瘤的漏诊率为 77%。
该研究表明，在具有与筛查试验阳性率高达 5%相匹配的结肠镜检查设施的国家，使用临界值在 100-150ng/mL 之间的 1 天检测可能是推荐的策略。在结肠镜检查机会有限的地区，可以进一步将临界值提高到与 Hemoccult 相同的阳性率。
