用于检测粪便中幽门螺杆菌抗原的酶免疫测定法与尿素呼气试验的比较。
Comparison of an enzyme immunoassay for the detection of Helicobacter pylori antigens in the faeces with the urea breath test.
作者信息
Shepherd A J, Williams C L, Doherty C P, Hossack M, Preston T, McColl K E, Weaver L T
机构信息
Department of Child Health, University of Glasgow, UK.
出版信息
Arch Dis Child. 2000 Sep;83(3):268-70. doi: 10.1136/adc.83.3.268.
BACKGROUND
Current diagnostic tests for Helicobacter pylori are invasive (endoscopy) or indirect (urea breath test, serology).
AIMS
To evaluate a new enzyme immunoassay (EIA) which detects H pylori antigens in faeces, by comparing its sensitivity and specificity in children with the (13)C urea breath test (UBT).
METHODS
A total of 119 children underwent a UBT and provided a faecal sample for antigen testing within seven days. After an overnight fast each child provided a pretest breath sample, and samples at 30 and 40 minutes after ingestion of 100 mg (13)C labelled urea. (13)C enrichment of breath was measured by isotope ratio mass spectrometry. Faeces were stored at -70 degrees C until antigen testing, using the EIA. Samples were read spectrophotometrically at 450 nm and results were interpreted using recommended cut offs of optical density <0.14 as negative, >/=0.16 as positive, with >/=0.14 and <0. 16 representing equivocal results. Sensitivity and specificity were calculated using the manufacturer's cut off compared with UBT.
RESULTS
Sensitivity and specificity were 88% and 82%, respectively. Negative and positive predictive values were 97% and 58%.
CONCLUSIONS
The EIA is an alternative, non-invasive, and easy to use method for the detection of H pylori in children. Its high negative predictive value suggests a role in screening out uninfected children.
背景
目前用于检测幽门螺杆菌的诊断测试要么具有侵入性（内镜检查），要么是间接性的（尿素呼气试验、血清学检测）。
目的
通过比较一种检测粪便中幽门螺杆菌抗原的新型酶免疫测定法（EIA）与儿童碳-13尿素呼气试验（UBT）的敏感性和特异性，对其进行评估。
方法
共有119名儿童接受了UBT检测，并在7天内提供粪便样本用于抗原检测。每个儿童在禁食过夜后提供一份检测前的呼气样本，以及在摄入100毫克碳-13标记尿素后30分钟和40分钟时的样本。呼气中的碳-13富集情况通过同位素比率质谱法进行测量。粪便样本保存在-70摄氏度下直至使用EIA进行抗原检测。样本在450纳米处进行分光光度法读数，并使用推荐的光密度临界值进行结果解读，光密度<0.14为阴性，≥0.16为阳性，≥0.14且<0.16表示结果不确定。与UBT相比，使用制造商规定的临界值计算敏感性和特异性。
结果
敏感性和特异性分别为88%和82%。阴性预测值和阳性预测值分别为97%和58%。
结论
EIA是一种用于检测儿童幽门螺杆菌的替代、非侵入性且易于使用的方法。其高阴性预测值表明在筛查未感染儿童方面具有一定作用。
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