Fecal Immunochemical Test (FIT) for Colon Cancer Screening: Variable Performance with Ambient Temperature.
Fecal Immunochemical Test (FIT) for Colon Cancer Screening: Variable Performance with Ambient Temperature.
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DOI：
10.3122/jabfm.2016.06.160060
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发表时间：
2016-11-12
期刊：
影响因子：
--
通讯作者：
Levin TR
中科院分区：
文献类型：
--
作者：
Doubeni CA;Jensen CD;Fedewa SA;Quinn VP;Zauber AG;Schottinger JE;Corley DA;Levin TR
粪便免疫化学试验（FIT）广泛用于结直肠癌（CRC）筛查，但由于收集的样本暴露于高温，血红蛋白降解可能会降低试验灵敏度。我们研究了环境温度暴露与FIT阳性率和灵敏度的关系。这是一项在北方加州凯萨医疗机构的CRC筛查项目中对50至75岁患者进行的回顾性队列研究，该项目于2007年开始每年向符合筛查条件的成员邮寄FIT试剂盒。主要结果是FIT阳性率和检测CRC的敏感性。预测因子是基于美国国家海洋和大气管理局数据的测试结果日期的月份、季节和每日环境温度。患者（n = 472，542）完成了1，141，162次FIT。每周检测阳性率范围为2.6%至8.0%（中位数为4.4%），并随月份（6月/7月与12月/1月比率[RR] =0.79，95%置信区间[CI]为0.76至0.83）和季节而显著变化。6月/7月的FIT敏感性（74.5%; 95% CI，72.5至76.6）低于1月/12月（78.9%; 95% CI，77.0至80.7）。在高环境温度下完成的FIT具有较低的阳性率和较低的灵敏度。改变试剂盒设计、标本运输实践或避免高温环境可能有助于优化FIT性能，但也可能增加检测复杂性并降低患者依从性，需要仔细研究。
Fecal immunochemical tests (FITs) are widely used in colorectal cancer (CRC) screening, but hemoglobin degradation, due to exposure of the collected sample to high temperatures, could reduce test sensitivity. We examined the relation of ambient temperature exposure with FIT positivity rate and sensitivity. This was a retrospective cohort study of patients 50 to 75 years in Kaiser Permanente Northern California’s CRC screening program, which began mailing FIT kits annually to screen-eligible members in 2007. Primary outcomes were FIT positivity rate and sensitivity to detect CRC. Predictors were month, season, and daily ambient temperatures of test result dates based on US National Oceanic and Atmospheric Administration data. Patients (n =472,542) completed 1,141,162 FITs. Weekly test positivity rate ranged from 2.6% to 8.0% (median, 4.4%) and varied significantly by month (June/July vs December/January rate ratio [RR] =0.79, 95% confidence interval [CI], 0.76 to 0.83) and season. FIT sensitivity was lower in June/July (74.5%; 95% CI, 72.5 to 76.6) than January/December (78.9%; 95% CI, 77.0 to 80.7). FITs completed during high ambient temperatures had lower positivity rates and lower sensitivity. Changing kit design, specimen transportation practices, or avoiding periods of high ambient temperatures may help optimize FIT performance, but may also increase testing complexity and reduce patient adherence, requiring careful study.
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