Daly Jeanette M, Bay Camden P, Levy Barcey T
The University of Iowa, Iowa City, IA, USA.
J Prim Care Community Health. 2013 Oct;4(4):245-50. doi: 10.1177/2150131913487561. Epub 2013 May 12.
Colorectal cancer (CRC) screening reduces the mortality due to CRC. It is important for health care providers to be aware of the variation in the products available for CRC screening.
The purpose of this study was to summarize the accuracy of results of individual fecal immunochemical test (FIT) products across pathology proficiency testing programs.
Secondary data analysis of proficiency testing programs' FIT results.
Four of 7 proficiency testing program's FIT evaluations were obtained for a 2-year period. Fourteen unique FIT brands were evaluated by at least 1 of the 4 proficiency testing programs. Five of the products performed similarly with sensitivities ranging from 98.1% to 98.8% and specificities from 98.1% to 99.6%. Ninety-three percent of the FIT tests completed were manual Clinical Laboratory Improvement Amendments-waived FITs.
About two thirds of the commonly used FIT products performed acceptably on spiked samples of human hemoglobin. However, some had low sensitivity and specificity and probably should not be used for population-based or other screening. Further investigation to determine appropriate, reliable products for fecal occult blood testing is warranted.
结直肠癌（CRC）筛查可降低CRC导致的死亡率。医疗保健提供者了解CRC筛查可用产品的差异很重要。
本研究的目的是总结各粪便免疫化学检测（FIT）产品在病理学能力验证计划中的结果准确性。
对能力验证计划的FIT结果进行二次数据分析。
在两年期间获得了7个能力验证计划中4个计划的FIT评估结果。14个不同的FIT品牌至少由4个能力验证计划中的1个进行了评估。其中5种产品表现相似，灵敏度范围为98.1%至98.8%，特异性范围为98.1%至99.6%。完成的FIT检测中有93%是经临床实验室改进修正案豁免的手动FIT检测。
约三分之二的常用FIT产品在人血红蛋白加标样本上表现可接受。然而，有些产品的灵敏度和特异性较低，可能不应将其用于基于人群的筛查或其他筛查。有必要进一步调查以确定用于粪便潜血检测的合适、可靠产品。
