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一种用于快速、定性检测粪便潜血的新型免疫检测试纸条装置。

A new immunological test strip device for the rapid, qualitative detection of faecal occult blood.

作者信息

Trojan J, Povse N, Schröder O, Stein J

机构信息

Medizinische Klinik II, Klinikum der Johann Wolfgang Goethe Universität, Frankfurt, Germany.

出版信息

Z Gastroenterol. 2002 Nov;40(11):921-4. doi: 10.1055/s-2002-35415.

DOI:10.1055/s-2002-35415
PMID:12436369
Abstract

OBJECTIVE

Guaiac tests for faecal occult blood are still the most commonly performed screening procedure for colorectal cancer. Because both sensitivity and specificity of faecal occult blood testing are critical to cost-effective colorectal cancer screening programs, we investigated a rapid immunological test strip device for bedside detection of faecal occult blood.

METHODS

Stool specimen from 100 patients were chosen for this study based on the presence (n = 50) or absence (n = 50) of faecal occult blood as measured with a human haemoglobin ELISA (cut-off level </= 10 micro g Hb/g stool). All specimens were analysed for faecal occult blood by a guaiac test (Hemocare) and an immunological test strip device (Prevent ID CC).

RESULTS

Sensitivity and specificity of the immunological faecal occult blood test strip device were 76 % and 92 %, compared to 30 % and 90 % for the guaiac test. Increasing the cut-off level of the haemoglobin ELISA to </= 20 micro g Hb/g stool, the corresponding sensitivity and specificity were 86 % and 83 % for the immunological test strip device and 42 % and 92 % for the guaiac faecal occult blood test, respectively. The highest positive predictive value was achieved with the immunological test strip device.

CONCLUSIONS

The new immunological test strip device is more sensitive than a guaiac test for the detection of faecal occult blood, whereas the specificity of both tests was comparable. However, the clinical validity of this new immunological faecal occult blood test strip device for colorectal cancer screening has to be established, yet.

摘要

目的

粪便潜血的愈创木脂试验仍是结直肠癌最常用的筛查方法。由于粪便潜血检测的敏感性和特异性对具有成本效益的结直肠癌筛查项目至关重要,我们研究了一种用于床边检测粪便潜血的快速免疫试纸条装置。

方法

根据用人血红蛋白酶联免疫吸附测定法(临界值≤10μg血红蛋白/克粪便)检测出的粪便潜血情况,选择100例患者的粪便标本进行本研究,其中有潜血的50例,无潜血的50例。所有标本均通过愈创木脂试验(Hemocare)和免疫试纸条装置(Prevent ID CC)分析粪便潜血情况。

结果

免疫法粪便潜血试纸条装置的敏感性和特异性分别为76%和92%,而愈创木脂试验的敏感性和特异性分别为30%和90%。将血红蛋白酶联免疫吸附测定法的临界值提高到≤20μg血红蛋白/克粪便时,免疫试纸条装置相应的敏感性和特异性分别为86%和83%,愈创木脂粪便潜血试验的敏感性和特异性分别为42%和92%。免疫试纸条装置的阳性预测值最高。

结论

新型免疫试纸条装置在检测粪便潜血方面比愈创木脂试验更敏感,而两种试验的特异性相当。然而,这种新型免疫粪便潜血试纸条装置用于结直肠癌筛查的临床有效性还有待确定。

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