Stool antigen tests for the management of Helicobacter pylori infection

Stool antigen tests(SATs)are noninvasive diagnostic modules for Helicobacter pylori(H.pylori)infection.Two types of SATs exist for the diagnosis of H.pylori infection,one based on enzyme immunoassay(EIA)and another on immunochromatography(ICA).SATs do not require expensive chemical agents or specified equipment;hence,they are less expensive compared with the urea breath test.Both European and Japanese guidelines have shown that EIA-based SATs using monoclonal antibodies are useful for primary diagnosis as well as for the assessment of eradication therapy.ICA-based tests do not require particular equipment and are therefore useful in developing countries.SATs are also useful for the diagnosis of H.pylori infection in children and post gastric surgery patients.SATs performed via EIA can assess H.pylori infection in a large number of subjects,almost as well as serology.Thus,SATs would be useful or detecting current infection in such a survey to identify and eradicate H.pylori infection.The accuracy of SATs is lower when the stool samples are unformed or watery,because H.pylorispecific antigens in the stool samples are diluted.Temperature and the interval between stool sample collection and measurement also affect the results of SATs.The choice of test kit depends on the sensitivity and specificity in each region and the circumstances of each patient.

Influence of proton pump inhibitor treatment on Helicobacter pylori stool antigen test

AIM: To investigate the effects of proton pump inhibitor (PPI) treatment on stool antigen test using the TestMate pylori enzyme immunoassay. METHODS: This study assessed 28 patients [16 men and 12 women; mean age (63.1 ± 5.9) years; range, 25-84 years] who underwent stool antigen test and urea breath test (UBT) before and after PPI administration. RESULTS: Using the UBT as the standard, the sensitivity, specif icity and agreement of the stool antigen test in all 28 patients were 95.2%, 71.4%, and 89.3%, respectively, before PPI administration, and 88.9%, 90.9%, and 89.3%, respectively, after PPI treatment. Mean UBT values were 23.98% ± 5.33% before and 16.19% ± 4.75% after PPI treatment and, in 15 patients treated for ≥ 4 wk, were signif icantly lower after than before 4 wk of PPI treatment (12.58% ± 4.49% vs 24.53% ± 8.53%, P = 0.048). The mean optical density (A450/630) ratios on the stool antigen test were 1.16 ± 0.20 before and 1.17 ± 0.24 after PPI treatment (P = 0.989), and were 1.02 ± 0.26 and 0.69 ± 0.28, respectively, in the group treated for > 4 wk (P = 0.099).

Comparison of a monoclonal antigen stool test (Hp StAR) with the ^(13)C-urea breath test in monitoring Helicobacter pylori eradication therapy

AIM： To evaluate the agreement between a mAb-based stool test （HP STAR） and the urea breath test （UBT） in monitoring （H pylon） infection after eradication therapy. METHODS： Patients with discordant results on UBT and Hp STAR underwent endoscopy with biopsies for rapid urease test, culture, and histology to confirm H pylori status. RESULTS： Among 250 patients （50±14 years）, 240 （96.0%） had concordant UBT and Hp STAR tests with a significant correlation between DOB and A values （R = 0.87; P〈0.0001）. The remaining 10 （4.0%） patients had discordant tests （positive Hp STAR and negative UBT） with the Hp STAR inaccurate in five cases （false positive） and UBT inaccurate in the other five cases （false negative）. The “maximal expected” sensitivity, specificity, ＋PV, -PV, ＋LR, and -LR were 91%, 100%, 100%, 97.4%, ∞, and 8.2 respectively, for the UBT, and 100%, 97.4%, 91%, 100%, 38.8, and 0, respectively, for the Hp STAR. Overall accuracy for both tests was 98%. CONCLUSION： Both the UBT and the Hp StAR are equally accurate in monitoring H pylori infection. Nowadays, the choice of the “best” non-invasive H pylori test in the post-treatment setting should be done not only in terms of diagnostic accuracy but also in view of cost and local facilities.

Retrospective analysis of discordant results between histology and other clinical diagnostic tests on helicobacter pylori infection

BACKGROUND A reliable test is essential for diagnosing Helicobacter pylori(H.pylori)infection,and crucial for managing H.pylori-related diseases.Serving as an excellent method for detecting H.pylori infection,histologic examination is a test that clinicians heavily rely on,especially when complemented with immunohistochemistry(IHC).Additionally,other diagnostic tests for H.pylori,such as the rapid urease test(CLO test)and stool antigen test(SA),are also highly sensitive and specific.Typically,the results of histology and other tests align with each other.However,on rare occasions,discrepancy between histopathology and other H.pylori diagnostic tests occurs.AIM To investigate the discordance between histology and other H.pylori tests,the underlying causes,and the impact on clinical management.METHODS Pathology reports of gastric biopsies were retrieved spanning August 2013 and July 2018.Reports were included in the study only if there were other H.pylori tests within seven days of the biopsy.These additional tests include CLO test,SA,and H.pylori culture.Concordance between histopathology and other tests was determined based on the consistency of results.In instances where histology results were negative while other tests were positive,the slides were retrieved for re-assessment,and the clinical chart was reviewed.RESULTS Of 1396 pathology reports were identified,each accompanied by one additional H.pylori test.The concordance rates in detecting H.pylori infection between biopsy and other tests did not exhibit significant differences based on the number of biopsy fragments.117 discrepant cases were identified.Only 20 cases(9 with CLO test and 11 with SA)had negative biopsy but positive results in other tests.Four cases initially stained with Warthin-Starry turned out to be positive for H.pylori with subsequent IHC staining.Among the remaining 16 true discrepant cases,10 patients were on proton pump inhibitors before the biopsy and/or other tests.Most patients underwent treatment,except for two who were untreated,and two patients who were lost to follow-up.CONCLUSION There are rare discrepant cases with negative biopsy but positive in SA or CLO test.Various factors may contribute to this inconsistency.Most patients in such cases had undergone treatment.

Helicobacter pylori infection- recent developments in diagnosis

Considering the recommended indications for Helicobacter pylori(H.pylori)eradication therapy and the broad spectrum of available diagnostic methods,a reliable diagnosis is mandatory both before and after eradication therapy.Only highly accurate tests should be used in clinical practice,and the sensitivity and specificity of an adequate test should exceed 90%.The choice of tests should take into account clinical circumstances,the likelihood ratio of positive and negative tests,the cost-effectiveness of the testing strategy and the availability of the tests.This review concerns some of the most recent developments in diagnostic methods of H.pylori infection,namely the contribution of novel endoscopic evaluation methodologies for the diagnosis of H.pylori infection,such as magnifying endoscopy techniques and chromoendoscopy.In addition,the diagnostic contribution of histology and the urea breath test was explored recently in specific clinical settings and patient groups.Recent studies recommend enhancing the number of biopsy fragments for the rapid urease test.Bacterial culture from the gastric biopsy is the gold standard technique,and is recommended for antibiotic susceptibility test.Serology is used for initial screening and the stool antigen test is particularly used when the urea breath test is not available,while molecular methods have gained attention mostly for detecting antibiotic resistance.

基于粪便样本检测幽门螺杆菌感染及耐药情况的研究进展

幽门螺杆菌(Helicobacter pylori,H.pylori)是一种革兰氏阴性细菌,特异性定植于人类的胃上皮,特别是胃窦上皮中。它是慢性胃炎、消化性溃疡、胃癌、胃黏膜相关淋巴组织淋巴瘤及一些胃外疾病的主要病因。由于H.pylori抗生素耐药菌株的迅速出现,其根治率正逐年下降。对抗生素耐药性进行检测,指导临床医师选择治疗方案是目前提高H.pylori根治率的重要手段。目前,H.pylori抗生素耐药性的检测主要是患者基于接受内镜检查的侵入性检测。而针对非侵入性手段获得粪便样本的检测相比于侵入性检测具有无创便捷、高效、依从性好等优点。近年来针对粪便样本进行抗原检测、分子检测等多种方式的研究均有报道。本文就基于粪便样本诊断H.pylori感染及检测其耐药情况的研究进展进行综述和分析,为探索更为便捷、高效的诊断方式和指导治疗手段提供思考。

体检人群幽门螺杆菌感染检测意愿调查

目的探讨体检人群对H.pylori感染检测的主动性及其对检测方式的倾向性。方法于2022年9月至2022年12月在国内两家综合性三甲医院的体检人员中发放电子调查问卷,问卷内容包括受访者对H.pylori感染及检测方式的了解情况,主动给自己及家中老人、儿童(<14岁)检测的意愿,及其对尿素呼气试验(urea breath test,UBT)和H.pylori粪便抗原试验(H.pylori stool antigen test,HpSAT)的比较与选择等。结果共回收488份有效问卷。消化道症状或疾病在体检人群(57.0%)及其家庭成员(35.5%)中普遍存在。体检人群对H.pylori感染的熟悉率仅为11.9%。43.0%受访者会在体检时主动检测,36.9%的受访者在医师建议下才会进行检测,而20.1%不会主动检测。影响检测主动性的因素主要是对H.pylori感染的了解程度。对于家中老人和儿童的检测,大部分体检人员需要医师建议才会进行检测。体检人员选择检测方式时,主要看其重准确性、方便性、安全性,超过80%体检人员会选择UBT。结论体检人群对H.pylori感染的认知水平较低,但检测意愿性较强,在检测时倾向于选择传统的UBT,对新兴的快速HpSAT缺乏了解。

幽门螺杆菌粪便抗原检测──一种新的非侵入性诊断方法

评估幽门螺杆菌粪便抗原（ＨｐＳＡ）检测诊断ＨＰ感染的可靠性。方法：收集４３例接受胃镜检查患者的粪 便标本，用一种市售的ＥＬＩＳＡ试剂盒检测ＨｐＳＡ；以尿素酶试验、培养和涂片染色检测Ｈｐ作为“金标准”，培养和／ 或涂片染色阳性定为Ｈｐ感染。结果：“金标准”诊断Ｈｐ阳性２４例，阴性１９例。“金标准”阳性的２４例ＨｐＳＡ检测均阳 性，阴性的１９例ＨｐＳＡ检测１８例阴性和１例阳性。ＨｐＳＡ试验的敏感性为１００％（２４／２４），特异性为９４．７％（１８／１９），总的 诊断准确率为９７．６％（４２／４３）。结论：ＨｐＳＡ试验是一简便、非侵入性、准确诊断Ｈｐ感染的新方法。

幽门螺杆菌粪便抗原和血清抗体胶体金试验联合检测在体检人群的应用价值

目的了解体检人群幽门螺杆菌（HP）感染情况，探讨粪便HP抗原和血清HP抗体胶体金试验联合检测体检人群HP感染的应用价值。方法采用14C-尿素呼气试验（14C—UBT）、粪便HP抗原及血清HP抗体胶体金试验三种方法对478名体检者进行HP检浸4并进行统计分析。结果三种方法检测478名体检者的HP阳性率分剐为43．7％，43．5％，45．6％，三种方法之问及男女性别之间的差异无统计学意义（P〉0．05），其中血清HP抗体胶体金试验的HP既往感染率为7．32％（35／478），粪便HP抗原与血清HP抗体胶体金试验联合检测体检人群既可以明确诊断现症感染又可以了解既往感染史。结论体检人群HP感染率低于慢性活动性胃炎、消化性溃疡病人的HP感染率；粪便HP抗原和血清HP抗体肢体金试验联合检测可以应用于普通人群的筛查，能同时反映其临床和流行病学意义。

粪便抗原检测临床诊断幽门螺杆菌感染的可靠性研究

背景:我国属于幽门螺杆菌(Hp)感染高发国家。在众多Hp感染检测方法中,Hp粪便抗原(HpS A)检测具有非侵入性、敏感性和特异性较高、操作简便、价格低廉等优势。目的:评价HpS A检测试剂盒临床诊断Hp感染的可靠性。方法:340例行13C-尿素呼气试验(13C-UBT)的受试者同时留取粪便标本,以待评估的酶联免疫法HpS A检测试剂盒检测Hp感染。以13C-UBT为金标准,计算待评估试剂盒诊断Hp感染的阳性符合率、阴性符合率、总符合率和κ系数。结果:与13C-UBT结果比对,待评估HpS A检测试剂盒诊断Hp感染的阳性符合率为96.3%,阴性符合率为75.8%,总符合率为87.4%,κ系数为0.737 522。结论:待评估的HpS A检测试剂盒用于临床诊断Hp感染,与金标准13C-UBT具有较高的符合率和一致性,结果可靠,可在临床上推广应用。

幽门螺杆菌粪便抗原检测在儿童中的应用价值研究

目的 :对幽门螺杆菌粪便抗原 (Helicobacterpyloristoolantigen ,HpSA)检测诊断儿童Hp感染的应用价值进行探讨。方法 :以快速尿素酶、组织学和细菌培养作为诊断Hp的金标准 (快速尿素酶试验、组织学和细菌培养其中 2项阳性则判定为Hp阳性 ,细菌培养 1项为阳性也判定为Bp阳性 ) ,采用ELISA法检测 4 0例因上消化道症状接受胃镜检查患儿的HpSA ,评价HpSA检测诊断儿童Hp感染的敏感性、特异性。同时在 2 9例患儿中以13 C -UBT作对照 ,评价HpSA检测诊断Hp感染的准确性。结果 :在 4 0例患儿中 ,HpSA检测的敏感性、特异性和准确性分别 94 .4 4 % ,90 .91%和 92 .5 0 % ;在 2 9例患儿中以13 C -UBT作标准 ,HpSA检测诊断Hp感染敏感性、特异性和准确性分别为 91.6 7% ,88.2 3%和 89.6 6 %。结论 :HpSA检测是一种方便、简单、准确的诊断儿童Hp感染的方法。

幽门螺杆菌粪便抗原检测法在幽门螺杆菌根除后患者中的效果

目的探讨幽门螺杆菌(Hp)粪便抗原检测(HpSA)在Hp根除后患者中的效果,为Hp感染患者后期复查提供依据。方法选取该院2011年12月至2013年12月进行Hp根治后的170例患者进行研究,所有患者均进行14C尿素呼气试验检测HpSA,观察HpSA检测Hp的灵敏度和准确率,为Hp感染的检测提供依据。结果与14C尿素呼气试验金标准检测比较,患者治疗1周后,HpSA试验检测灵敏度为78.08%,诊断正确率为68.24%;患者治疗2周后HpSA试验检测灵敏度为74.12%,诊断正确率为54.71%;患者治疗3周后,HpSA试验检测灵敏度为46.38%,诊断正确率为47.65%。结论 HpSA检测方法的诊断准确率高、灵敏度高、特异度高、适用于Hp的诊断,尤其适用于儿童、老年患者的筛查及无法开展13C或14C-尿素呼气试验的贫困地区,且检测值不受患者是否进行治疗的影响。

粪便抗原检测儿童及青少年幽门螺杆菌感染诊断试验的系统评价

目的:采用Meta分析的方法评价幽门螺杆菌粪便抗原(H pylori stool antigen,HpSA)诊断儿童H pylori感染的价值,为临床应用提供依据.方法:以"幽门螺杆菌"、"儿童""诊断性试验"、"粪便抗原"、"诊断准确性"为检索词,通过联机检索CNKI中国期刊全文数据库、CBM中国生物医学文献数据库,文献追溯和手工检索的方法收集发表时间为1998-01/2008-05国内正式刊物上公开发表的有关评价粪便抗原检测H pylori感染准确性的相关研究文献.按确定的纳入、排除标准进行筛选,采用QUADAS工具对纳入的文献进行质量评价,应用MetaDisc1.4软件进行Meta分析,综合评价灵敏度、特异度、似然比、诊断优势比和SROC曲线下面积、Q*指数等指标.结果:共17篇文献符合纳入标准,各研究间具有同质性.共累计样本含量1466例,由金标准确诊H pylori感染737例,非感染729例.Meta分析结果显示各研究之间的一致性较高,粪便抗原诊断H pylori感染的合并敏感度、特异度分别是92%(95%CI90%-94%)和92%(95%CI90%-94%);合并阳性似然比、阴性似然比分别为11.44(95%CI8.83-14.81)和0.10(95%CI0.08-0.13).合并诊断优势比DOR126.14(84.84-187.55).绘制SROC曲线,估计SROC曲线下面积AUC=0.9696,Q*=0.9193.结论:粪便抗原检测儿童及青少年Hpylori感染的方法准确度较高.

粪便抗原检测诊断幽门螺杆菌现症感染

目的 评价应用免疫酶联吸附试验(ELISA)检测粪便中幽门螺杆菌(Helicobacter pylori)抗原诊断 H.pylori现症感染的敏感性和特异性。方法 应用^(14)C呼气试验以及幽门螺杆菌粪便抗原(HpSA)试验,对100例因上消化道不适就诊,怀疑有H.pylori感染的患者进行检测,观察两种检查的符合率。结果^(14)C呼气试验和HpSA同时阳性者38例,^(14)C呼气试验阳性而HpSA阴性者4例;^(14)C呼气试验和HpSA同时阴性者57例,^(14)C呼气试验阴性而HpSA阳性1例。以^(14)C呼气试验作为金标准计算,HpSA检测方法的敏感性为90.48％,特异性为98.28％。结论 幽门螺杆菌抗粪便原检测与^(14)C呼气试验有较高的符合率,而且简便易行,不需特殊设备,解决了无法进行呼气试验的婴幼儿和有肺部疾患者的非侵入性幽门螺杆菌现症感染诊断问题,是一种非侵入性幽门螺杆菌现症感染诊断的新方法。

粪便幽门螺杆菌抗原检测试验实用性及临床价值分析

目的分析粪便幽门螺杆菌抗原(HpSA)检测试验的实用性和临床价值。方法选择有上消化道症状的患者208例作为研究对象,同时采用^(14)C尿素酶呼气试验(^(14)C-UBT)和HpSA检测试验分析患者幽门螺杆菌(Hp)感染情况,以^(14)C-UBT的检测结果作为诊断标准,分析HpSA检测试验诊断Hp感染的价值。结果HpSA检测试验与^(14)C-UBT检测结果的阳性率差异无统计学意义(χ^(2)=0.161,P=0.688)。两种方法的一致性强(Kappa=0.84)。HpSA检测试验有较高的阳性预测值、阴性预测值、灵敏度、特异度和准确度,分别为95.16%、88.10%、92.19%、92.50%、92.31%。结论HpSA检测试验准确性良好,具有无创、经济、检测速度快等优点。该方法适用于基层医院进行Hp感染的筛查、复查和流行病学调查,亦适用于儿童、老年人Hp感染的检查。

幽门螺杆菌粪便抗原检测——一种新的非侵入性检查

目的:了解幽门螺杆菌粪便抗原检测方法(Helicobacter pylori stool Antigen HpSA)的准确性与可靠性。方法:采用酶联免疫分析“双抗体夹心法”对303例因上消化道症状而进行胃镜检查的患者的粪便标本进行幽门螺杆菌检测,以快速尿素酶试验,组织学染色和培养检测Hp,以三项检查中至少两项阳性或Hp培养检测阳性者判定为Hp感染作为“金标准”。结果;“金标准”诊断Hp感染阳性182例,阴性121例。“金标准”阳性的182例中176例HpSA检测阳性,阴性的121例中100例HpSA检测阴性,HpSA敏感度为96.7％(176/182),特异度为82.6％(100/121)。结论:HpSA检测是一种简便易行,准确性高的非侵入性诊断Hp的方法,值得临床进一步推广。

粪便标本抗原检测诊断儿童幽门螺杆菌感染

目的 进行非侵入性粪便标本幽门螺杆菌抗原检测诊断儿童幽门螺杆菌 (H .pylori)感染 ,并评价此试验方法的应用价值。方法 选择有上消化道症状的 4 8例患儿为研究对象 ,采用H .pylori抗原检测试剂盒 ,以酶联免疫分析双抗体夹心法检测粪便H .pylori抗原 ,并与胃粘膜活检标本快速尿素酶试验、组织学、血清学试验作对比研究。结果 4种诊断试验诊断准确率分别为 :粪便抗原试验 95 .8% ,快速尿素酶试验 95 .9% ,组织学 97.9% ,血清学 83.7%。粪便抗原试验的特异度和敏感度分别为 10 0 % ,93.6 %。结论 粪便标本H .pylori抗原试验诊断儿童幽门螺杆菌感染有较高的准确率、敏感性和特异性 。

应用ROC曲线评价酶免疫法检测粪便幽门螺杆菌特异性抗原试验的临床价值

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。

儿童幽门螺杆菌粪便抗原检测

幽门螺杆菌(Hp)感染是导致胃十二指肠疾病的重要原因,可引起胃炎、消化道溃疡、胃癌等胃十二指肠疾病。临床上对Hp具有多种检测方法。Hp粪便抗原检测是近年来一种新的非侵入性的Hp检测方法,具有操作简单、安全方便、性价比高、易被患者接受等优点,尤其适用于儿童Hp感染的检测。现就Hp粪便抗原检测试验原理、方法、影响因素及与其他检测方法的对比,以及在Hp感染的诊断、随访及流行病学调查等方面的应用加以综述。

规范幽门螺杆菌感染诊断,提高诊断准确性

根除幽门螺杆菌(Hp)是防治慢性胃炎、消化性溃疡和胃癌的重要措施,我国Hp感染处理共识已将“证实有Hp感染”作为根除指征。世界胃肠病学组织指南指出,“治疗所有Hp阳性者,如无意治疗就不要检测”。准确诊断Hp感染是规范化根除治疗的前提。Hp感染的诊断方法多样,各有其优缺点,不同方法适用于不同疾病和患者,每种方法对试剂、设备、检测者和患者都有严格的要求。因此,提高临床医师和检测者对规范诊断的认知,对提高Hp感染诊断的准确性至关重要。