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样本返回时间和环境温度对采用新型缓冲液进行结直肠癌筛查的免疫化学粪便潜血试验性能的影响。

Influence of sample return time and ambient temperature on the performance of an immunochemical faecal occult blood test with a new buffer for colorectal cancer screening.

作者信息

Dancourt Vincent, Hamza Samia, Manfredi Sylvain, Drouillard Antoine, Bidan Jeanne-Marie, Faivre Jean, Lepage Come

机构信息

aRegistre Bourguignon des cancers digestifs, INSERM U866; Université de Bourgogne; CHU de Dijon bADECA 21-58 cLaboratoire du CES de la CPAM Dijon, France.

出版信息

Eur J Cancer Prev. 2016 Mar;25(2):109-14. doi: 10.1097/CEJ.0000000000000153.

Abstract

The haemoglobin concentration measured by faecal immunochemical tests (FIT) may be decreased in cases of delayed sample return or high temperature. It is an issue of great importance. The aim of this study was to investigate the effects of sample return time and of season on the performance of an FIT (FOB-Gold) with a new buffer. The study included 20 371 participants involved in the French organized colorectal cancer (CRC) screening programme. The probability of a positive screening test, detection rates and positive predictive values for CRC and advanced adenoma were analysed according to sample return time and season of screening. A sample of positive FIT was stored for 7 days in an incubator at 20°C or 30°C. The positivity rate was 4.1% for a sample return time of up to 3 days, 4.1% for 4-5 days and 4.6% for 6-7 days (P=0.25). In multivariate analysis, there was no association between positivity rates, detection rates and positive predictive values for CRC and advanced adenoma and the sample return time or the season of screening. At a constant temperature of 20°C, there was a decrease in the haemoglobin concentration of 5.1% after 7 days. The decrease reached 20.5% at a temperature of 30°C. It was only 4.5% during the first 4 days of storage in the incubator. With the new buffer, delay in sample return or season did not affect the clinical outcome. When temperatures reach 30°C, the faecal sample must be returned promptly.

摘要

粪便免疫化学检测(FIT)所测得的血红蛋白浓度在样本返回延迟或温度较高的情况下可能会降低。这是一个非常重要的问题。本研究的目的是调查样本返回时间和季节对采用新型缓冲液的FIT(FOB-Gold)性能的影响。该研究纳入了参与法国有组织的结直肠癌(CRC)筛查项目的20371名参与者。根据样本返回时间和筛查季节,分析了CRC和进展期腺瘤的筛查试验阳性概率、检出率和阳性预测值。将一份FIT阳性样本在20°C或30°C的培养箱中保存7天。样本返回时间长达3天的阳性率为4.1%,4 - 5天的为4.1%,6 - 7天的为4.6%(P = 0.25)。在多变量分析中,CRC和进展期腺瘤的阳性率、检出率和阳性预测值与样本返回时间或筛查季节之间无关联。在20°C恒温条件下,7天后血红蛋白浓度下降了5.1%。在30°C温度下,下降幅度达到20.5%。在培养箱中保存的前4天,下降幅度仅为4.5%。使用新型缓冲液时,样本返回延迟或季节不会影响临床结果。当温度达到30°C时,粪便样本必须及时返回。

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