False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening
False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening
复制标题
DOI：
10.1002/ijc.24458
复制
发表时间：
2009-08-15
影响因子：
6.4
通讯作者：
Dekker, Evelien
中科院分区：
文献类型：
--
作者：
van Rossum, Leo G. M.;van Rijn, Anne F.;Dekker, Evelien
延迟将免疫化学粪便潜血试验（iFOBT）样本返回实验室可能会因血红蛋白降解而导致假阴性。定量iFOBT在结直肠癌筛查中越来越被接受。因此，我们研究了采样和实验室交付之间的延迟对iFOBT性能的影响。IFOBT阳性（>= 50 ng/ml血红蛋白）在结直肠癌筛查参与者中，在采样和实验室交付之间没有延迟（< 5天），与阳性参与者进行比较，延迟>= 5和>= 7天。此外，阳性检测结果在室温下储存，并在10-14天内重新检测5次。61%（n = 3，767）的参与者报告了采样日期：19%的延迟>= 5天，5% >= 7天。与未延迟相比，延迟2、5天后腺瘤检出率已显著降低（OR 0.6; 95%CI 0.4-0.9）。我们重新测试了170例阳性的iFOBT样本，其中139例（82%）进行了结肠镜检查：45例（32%）患有晚期腺瘤（非结直肠癌），8例（6%）患有结直肠癌。平均每日粪便血红蛋白减少为29 ng/ml（S.D. 38和中位数11 ng/ml）。在晚期腺瘤患者中，在初始测试后23天内，5例（11%）样本中的血红蛋白< 50 ng/ml，在10-14天后，16例（36%）样本中的血红蛋白< 50 ng/ml。初次检测后7天，2例（25%）结直肠癌患者成为假阴性。两人都患有I期结直肠癌，初始值低于100 ng/ml，其中I期的平均值为532 ng/ml。样本返回延迟增加了假阴性免疫化学FOBT。主要是前体病变，但也包括结直肠癌，将由于样本返回延迟而被遗漏。(C)2009年UICC
Delayed return of immunochemical fecal occult blood test (iFOBT) samples to a laboratory might cause false negatives because of hemoglobin degradation. Quantitative iFOBT's became increasingly more accepted in colorectal cancer screening. Therefore, we studied the effects of delay between sampling and laboratory delivery on iFOBT performance. IFOBT positivity (>= 50 ng/ml hemoglobin) in colorectal cancer screening participants without delay between sampling and laboratory delivery (< 5 days), was compared with positivity in participants with >= 5 and >= 7 days delay. Additionally, positive tests were stored at room temperature and retested 5 times within 10-14 days. The sampling date was reported by 61% (n = 3,767) of the participants: in 19% delay was >= 5 days and in 5% >= 7 days. Compared with no-delay, the adenoma detection rate was already significantly decreased after 2,5 days delay (OR 0.6; 95% CI 0.4-0.9). We retested iFOBT samples of 170 positives of which 139 (82%) had a colonoscopy: 45 (32%) had advanced adenomas (not colorectal cancer) and 8 (6%) had colorectal cancer. Mean daily fecal hemoglobin decrease was 29 ng/ml (S.D. 38 and median 11 ng/ml). In patients with advanced adenomas, hemoglobin in the sample was < 50 ng/ml in 5 (11%) 23 days after the initial test and in 16 (36%) after 10-14 days. Seven days after the initial test, 2 (25%) colorectal cancer patients became false negative. Both had stage I colorectal cancer and initial values below 100 ng/ml, where the average for stage I is 532 ng/ml. Delay in sample return increased false negative immunochemical FOBT's. Mainly precursor lesions, but also colorectal cancer, will be missed due to delayed sample return. (C) 2009 UICC