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三种用于结直肠癌筛查的定量免疫化学粪便隐血试验的分析比较。

Analytical comparison of three quantitative immunochemical fecal occult blood tests for colorectal cancer screening.

机构信息

INSERM ERI3 Cancers & Populations, University of Caen Basse-Normandie (UCBN), University Hospital (CHU de Caen), Caen, France.

出版信息

Cancer Epidemiol Biomarkers Prev. 2011 Jul;20(7):1492-501. doi: 10.1158/1055-9965.EPI-10-0594. Epub 2011 May 16.

DOI:10.1158/1055-9965.EPI-10-0594
PMID:21576271
Abstract

BACKGROUND

The superiority of several immunochemical fecal occult blood tests (I-FOBT) over guaiac-based tests in colorectal cancer screening is now established. The aim of this study was to compare the analytical performance of 3 quantitative I-FOBTs.

METHODS

Stool samples from 10 healthy volunteers, initially I-FOBT negative, supplemented with human blood, were used to compare reproducibility and stability of measurement at varying storage temperatures (4°C, 10°C, 20°C, and 30°C) and durations before test analysis (1 to 10 days) for 3 I-FOBTs (New Hemtube/Magstream HT, OC-Auto sampling bottle3/OC-Sensor DIANA, and FOB Gold/SENTiFOB). Concentrations ranging from 0 to 350 μg Hb/g of feces were evaluated.

RESULTS

The measurement reproducibility of OC-Sensor was superior to Magstream and far superior to FOB Gold. For all tests, variability was essentially related to sampling. Detected hemoglobin (Hb) levels were substantially lower for all tests at temperatures above 20°C. At 20°C, this loss in concentration was less important with OC-Sensor (significant 1.7% daily decrease vs. 7.4% for Magstream and 7.8% for FOB Gold). At 30°C, daily loss was 8.6% with OC-Sensor, whereas after 24 hours, only 30% of the original Hb was detected with FOB Gold, compared to 70% with Magstream. No Hb was detected on day 5 for the latter 2 tests.

CONCLUSIONS

About reproducibility and temperature stability, OC-Sensor performed better than Magstream and far better that FOB Gold.

IMPACT

Independently of the chosen test, the delay between sampling and test processing should be reduced, the maximal admissible delay depending on ambient temperature.

摘要

背景

几种基于免疫化学的粪便潜血检测(I-FOBT)在结直肠癌筛查中的优越性已得到证实。本研究旨在比较 3 种定量 I-FOBT 的分析性能。

方法

使用 10 名健康志愿者的粪便样本,这些样本最初 I-FOBT 检测结果为阴性,并添加人血,以比较 3 种 I-FOBT(New Hemtube/Magstream HT、OC-Auto sampling bottle3/OC-Sensor DIANA 和 FOB Gold/SENTiFOB)在不同储存温度(4°C、10°C、20°C 和 30°C)和检测前分析时间(1 至 10 天)下的重复性和稳定性。评估了粪便中血红蛋白(Hb)浓度范围为 0 至 350μg/g 的情况。

结果

OC-Sensor 的测量重复性优于 Magstream,远优于 FOB Gold。对于所有检测,可变性主要与采样有关。所有检测的检测到的血红蛋白(Hb)水平在温度高于 20°C 时均显著降低。在 20°C 时,OC-Sensor 检测到的 Hb 浓度降低幅度较小(与 Magstream 相比,每天显著减少 1.7%,而与 FOB Gold 相比,每天减少 7.4%)。在 30°C 时,OC-Sensor 的每日损失为 8.6%,而在 24 小时后,FOB Gold 仅检测到原始 Hb 的 30%,而 Magstream 则为 70%。后两种检测在第 5 天未检测到 Hb。

结论

在重复性和温度稳定性方面,OC-Sensor 的性能优于 Magstream,远优于 FOB Gold。

影响

无论选择哪种检测方法,都应减少采样和检测处理之间的延迟,最大允许延迟取决于环境温度。

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