AIM To assess the diagnostic accuracy of a new fecal test for detecting Helicobacter pylori(H. pylori), using ^(13)Curea breath test as the reference standard, and explore bacterial antibiotic resistance. METHODS We c...AIM To assess the diagnostic accuracy of a new fecal test for detecting Helicobacter pylori(H. pylori), using ^(13)Curea breath test as the reference standard, and explore bacterial antibiotic resistance. METHODS We conducted a prospective two-center diagnostic test accuracy study. We enrolled consecutive people≥ 18 years without previous diagnosis of H. pylori infection, referred for dyspepsia between February and October 2017. At enrollment, all participants underwent 13 C-urea breath test. Participants aged over 50 years were scheduled to undergo upper endoscopy with histology. Participants collected stool samples 1-3 d after enrollment for a new fecal investigation(THD fecal test). The detection of bacterial 23 S rRNA subunit gene indicated H. pylori infection. We also used the index diagnostic test to examine mutations conferring resistance to clarithromycin and levofloxacin. Independent investigators analyzed index test and reference test standard results blinded to the other test findings. We estimated sensitivity, specificity, positive(PPV) and negative(NPV) predictive value, diagnostic accuracy, positive and negative likelihood ratio(LR), together with 95% confidence intervals(CI).RESULTS We enrolled 294 consecutive participants(age: Median 37.0 years, IQR: 29.0-46.0 years; men: 39.8%). Ninetyfive(32.3%) participants had a positive ^(13)C-urea breath test. Twenty-three(7.8%) participants underwent upper endoscopy with histology, with a full concordance between ^(13)C-urea breath test and histology in detecting H. pylori infection. Four(1.4%) out of the 294 participants withdrew from the study after the enrollment visit and did not undergo THD fecal testing. In the 290 participants who completed the study, the THD fecal test sensitivity was 90.2%(CI: 84.2%-96.3%), specificity 98.5%(CI:96.8%-100%), PPV 96.5%(CI: 92.6%-100%), NPV 95.6%(CI: 92.8%-98.4%), accuracy 95.9%(CI: 93.6%-98.2%), positive LR 59.5(CI: 19.3-183.4), negative LR 0.10(CI: 0.05-0.18). Out of 83 infected participants identified with the TH展开更多
目的探讨粪便幽门螺杆菌(Hp)特异性抗原(HpSA)在诊断Hp感染中的临床价值。方法按照随机、对照、盲法的原则,采用酶免疫法(EIA)检测353例因上消化道症状就诊于该院消化内科门诊或住院患者的HpSA,以13C-尿素呼气试验检查(13C-UBT)作为诊...目的探讨粪便幽门螺杆菌(Hp)特异性抗原(HpSA)在诊断Hp感染中的临床价值。方法按照随机、对照、盲法的原则,采用酶免疫法(EIA)检测353例因上消化道症状就诊于该院消化内科门诊或住院患者的HpSA,以13C-尿素呼气试验检查(13C-UBT)作为诊断Hp感染的"金标准",应用ROCKIT for windows 1.1β软件和SPSS15.0软件对数据进行统计学分析,应用不拘分布形式参数法(拟合双正态模型参数法)和非参数法分别绘制光滑受试者操作特征分析曲线(receiver operating characteristic curve,ROC curve)和经验ROC曲线,以曲线下面积(Az)评价HpSA试验的诊断价值。结果χ2检验表明EIA法检测Hp感染与"金标准"比较差异无显著性(P>0.05);诊断试验的一般指标:EIA法检测HpSA敏感度94.35%,特异度98.30%,阳性预测值98.24%,阴性预测值94.54%,阳性似然比55.5,阴性似然比0.06,符合率96.32%,优势比963.03,Youden指数0.93,Kappa值0.93;EIA法检测HpSA的不拘分布形式参数法和非参数法ROC曲线下面积分别为0.966和0.944,与完全无诊断价值的机会线下面积0.50相比差异有显著性(P<0.001)。结论HpSA是一种非侵入性诊断Hp感染的方法,该法简便易行,准确性和可靠性均较高,值得临床进一步推广。展开更多
文摘AIM To assess the diagnostic accuracy of a new fecal test for detecting Helicobacter pylori(H. pylori), using ^(13)Curea breath test as the reference standard, and explore bacterial antibiotic resistance. METHODS We conducted a prospective two-center diagnostic test accuracy study. We enrolled consecutive people≥ 18 years without previous diagnosis of H. pylori infection, referred for dyspepsia between February and October 2017. At enrollment, all participants underwent 13 C-urea breath test. Participants aged over 50 years were scheduled to undergo upper endoscopy with histology. Participants collected stool samples 1-3 d after enrollment for a new fecal investigation(THD fecal test). The detection of bacterial 23 S rRNA subunit gene indicated H. pylori infection. We also used the index diagnostic test to examine mutations conferring resistance to clarithromycin and levofloxacin. Independent investigators analyzed index test and reference test standard results blinded to the other test findings. We estimated sensitivity, specificity, positive(PPV) and negative(NPV) predictive value, diagnostic accuracy, positive and negative likelihood ratio(LR), together with 95% confidence intervals(CI).RESULTS We enrolled 294 consecutive participants(age: Median 37.0 years, IQR: 29.0-46.0 years; men: 39.8%). Ninetyfive(32.3%) participants had a positive ^(13)C-urea breath test. Twenty-three(7.8%) participants underwent upper endoscopy with histology, with a full concordance between ^(13)C-urea breath test and histology in detecting H. pylori infection. Four(1.4%) out of the 294 participants withdrew from the study after the enrollment visit and did not undergo THD fecal testing. In the 290 participants who completed the study, the THD fecal test sensitivity was 90.2%(CI: 84.2%-96.3%), specificity 98.5%(CI:96.8%-100%), PPV 96.5%(CI: 92.6%-100%), NPV 95.6%(CI: 92.8%-98.4%), accuracy 95.9%(CI: 93.6%-98.2%), positive LR 59.5(CI: 19.3-183.4), negative LR 0.10(CI: 0.05-0.18). Out of 83 infected participants identified with the TH
文摘目的探讨粪便幽门螺杆菌(Hp)特异性抗原(HpSA)在诊断Hp感染中的临床价值。方法按照随机、对照、盲法的原则,采用酶免疫法(EIA)检测353例因上消化道症状就诊于该院消化内科门诊或住院患者的HpSA,以13C-尿素呼气试验检查(13C-UBT)作为诊断Hp感染的"金标准",应用ROCKIT for windows 1.1β软件和SPSS15.0软件对数据进行统计学分析,应用不拘分布形式参数法(拟合双正态模型参数法)和非参数法分别绘制光滑受试者操作特征分析曲线(receiver operating characteristic curve,ROC curve)和经验ROC曲线,以曲线下面积(Az)评价HpSA试验的诊断价值。结果χ2检验表明EIA法检测Hp感染与"金标准"比较差异无显著性(P>0.05);诊断试验的一般指标:EIA法检测HpSA敏感度94.35%,特异度98.30%,阳性预测值98.24%,阴性预测值94.54%,阳性似然比55.5,阴性似然比0.06,符合率96.32%,优势比963.03,Youden指数0.93,Kappa值0.93;EIA法检测HpSA的不拘分布形式参数法和非参数法ROC曲线下面积分别为0.966和0.944,与完全无诊断价值的机会线下面积0.50相比差异有显著性(P<0.001)。结论HpSA是一种非侵入性诊断Hp感染的方法,该法简便易行,准确性和可靠性均较高,值得临床进一步推广。
