Department of Radiotherapy, The Chinese PLA 309th Hospital, Beijing, 100091, P.R. China.
BioChain (Beijing) Science and Technology, Inc., Beijing, 100176, P.R. China.
Sci Rep. 2017 Jun 8;7(1):3032. doi: 10.1038/s41598-017-03321-8.
The SEPT9 gene methylation assay is the first FDA-approved blood assay for colorectal cancer (CRC) screening. Fecal immunochemical test (FIT), FIT-DNA test and CEA assay are also in vitro diagnostic (IVD) tests used in CRC screening. This meta-analysis aims to review the SEPT9 assay performance and compare it with other IVD CRC screening tests. By searching the Ovid MEDLINE, EMBASE, CBMdisc and CJFD database, 25 out of 180 studies were identified to report the SEPT9 assay performance. 2613 CRC cases and 6030 controls were included, and sensitivity and specificity were used to evaluate its performance at various algorithms. 1/3 algorithm exhibited the best sensitivity while 2/3 and 1/1 algorithm exhibited the best balance between sensitivity and specificity. The performance of the blood SEPT9 assay is superior to that of the serum protein markers and the FIT test in symptomatic population, while appeared to be less potent than FIT and FIT-DNA tests in asymptomatic population. In conclusion, 1/3 algorithm is recommended for CRC screening, and 2/3 or 1/1 algorithms are suitable for early detection for diagnostic purpose. The SEPT9 assay exhibited better performance in symptomatic population than in asymptomatic population.
SEPT9 基因甲基化检测是首个获得美国食品药品监督管理局（FDA）批准用于结直肠癌（CRC）筛查的血液检测方法。粪便免疫化学检测（FIT）、FIT-DNA 检测和 CEA 检测也是 CRC 筛查中使用的体外诊断（IVD）检测方法。本荟萃分析旨在评估 SEPT9 检测的性能，并将其与其他 IVD CRC 筛查检测方法进行比较。通过在 Ovid MEDLINE、EMBASE、CBMdisc 和 CJFD 数据库中进行检索，确定了 180 项研究中的 25 项研究报告了 SEPT9 检测的性能。共纳入 2613 例 CRC 病例和 6030 例对照，采用不同算法评估其性能，以敏感性和特异性为指标。1/3 算法的敏感性最佳，而 2/3 和 1/1 算法的敏感性和特异性平衡最佳。在有症状人群中，血液 SEPT9 检测的性能优于血清蛋白标志物和 FIT 检测，而在无症状人群中，其性能似乎不如 FIT 和 FIT-DNA 检测。总之，推荐使用 1/3 算法进行 CRC 筛查，2/3 或 1/1 算法适用于诊断目的的早期检测。SEPT9 检测在有症状人群中的性能优于无症状人群。
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