Departments of Laboratory Medicine and Pathology.
Biomedical Informatics and Medical Education, University of Washington School of Medicine.
J Clin Gastroenterol. 2024 Jul 1;58(6):602-606. doi: 10.1097/MCG.0000000000001928.
We aimed to determine the performance of the OC-Auto Micro 80 fecal immunochemical test (FIT) in an average-risk population receiving care in an integrated, academic-community health system.
The FIT is the most used colorectal cancer (CRC) screening test worldwide. However, many Food and Drug Administration-cleared FIT products have not been evaluated in clinical settings.
We performed a retrospective cohort study of patients (50 to 75 y old) in the University of Washington Medicine health care system who were screened for CRC by OC-Auto Micro 80 FIT between March 2016 and September 2021. We used electronic health records to extract patient-level and clinic-level factors, FIT use, colonoscopy, and pathology findings. The primary outcomes were the FIT positivity rate and neoplasms detected at colonoscopy. Secondary outcomes were FIT positivity by sex and safety-net versus non-safety-net clinical settings.
We identified 39,984 FITs completed by 26,384 patients; 2411 (6.0%) had a positive FIT result (>100 ng/mL of hemoglobin in buffer), and 1246 (51.7%) completed a follow-up colonoscopy. The FIT positive rate was 7.0% in men and 5.2% in women ( P <0.01). Among those who completed a colonoscopy after an abnormal FIT result, the positive predictive value for CRC, advanced adenoma, and advanced neoplasia was 3.0%, 20.9%, and 23.9%, respectively.
In a retrospective analysis of a large heterogeneous population, the OC-Auto Micro 80 FIT for CRC screening demonstrated a positivity rate of 6.0% and a positive predictive value for CRC of 3.0%.
我们旨在确定 OC-Auto Micro 80 粪便免疫化学检测（FIT）在接受综合学术社区卫生系统护理的一般风险人群中的表现。
FIT 是全球使用最广泛的结直肠癌（CRC）筛查检测方法。然而，许多已获得美国食品和药物管理局批准的 FIT 产品尚未在临床环境中进行评估。
我们对华盛顿大学医学保健系统中接受 OC-Auto Micro 80 FIT 筛查的患者（50 至 75 岁）进行了回顾性队列研究，该研究于 2016 年 3 月至 2021 年 9 月进行。我们使用电子健康记录提取患者水平和临床水平的因素、FIT 使用、结肠镜检查和病理发现。主要结局是 FIT 阳性率和结肠镜检查中发现的肿瘤。次要结局是按性别和安全网与非安全网临床环境进行的 FIT 阳性率。
我们确定了 39984 例 FIT 完成情况，涉及 26384 名患者；2411 例（6.0%）FIT 结果阳性（缓冲液中血红蛋白>100ng/mL），1246 例（51.7%）完成了后续结肠镜检查。男性 FIT 阳性率为 7.0%，女性为 5.2%（P<0.01）。在异常 FIT 结果后完成结肠镜检查的患者中，CRC、高级腺瘤和高级肿瘤的阳性预测值分别为 3.0%、20.9%和 23.9%。
在对大型异质人群的回顾性分析中，OC-Auto Micro 80 FIT 用于 CRC 筛查的阳性率为 6.0%，CRC 的阳性预测值为 3.0%。
