Comparison of invasive methods and two different stool antigen tests for diagnosis of H pylori infection in patients with gastric bleeding

AIM： To compare two different H pylori stool antigen tests as noninvasive diagnostic methods. METHODS： The study population consisted of 22 upper gastrointestinal system bleeding patients. Urea breath test （UBT）, rapid urease test （RUT） and histopathological examination were applied to all patients. Stool specimens from these patients were examined by rapid STPIP!HpSA and one step simple H pylori antigen cassette test for the detection of Hpylori antigens. RESULTS： For these 22 patients, 15 （68.2%） were diagnosed as positive and seven （31.8%） were diagnosed negative for H pylori infection by the gold standard methods. Whereas 10 （45.5%） were positive and 12 （54.5%） were diagnosed negative by the rapid STPIP!HpSA test. The sensitivity, specificity, positive and negative predictive values were 60%, 86%, 90% and 50%, respectively. When compared to the gold standard methods, these differences were not significant. However, six patients （27.3%） were positive, and 16 （72.7%） were negative by the simple H pylori stool antigen cassette test. The sensitivity, specificity, positive and negative predictive values were 33%, 86%, 83% and 38%, respectively. Compared to the gold standard methods, the simple H pylori stool antigen cassette test results were significantly different （P = 0.012）. CONCLUSION： Rapid STRIP!HpSA test could be used as a routine diagnostic tool in the microbiology laboratory for assessing clinical significance and eradication control of H pylori in upper gastrointestinal system bleeding patients.

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.

A Retrospective Analysis of Three Non-Invasive Tests for Initial Diagnosis of <i>Helicobacter pylori</i>Infection in Children

Proper diagnosis in the pediatric population is required to eradicate Helicobacter pylori (H. pylori) and prevent gastric cancer. Our aim was to assess the performance of non-invasive tests to diagnose H. pylori infection in pediatric patients. A retrospective analysis was performed on 141 pediatric patients requiring endoscopic evaluation and diagnostic tests for H. pylori infection to define the cause of abdominal symptoms. Non-invasive tests included the 13C-urea breath test (UBT), a monoclonal stool antigen test using enzyme-linked immuno-sorbent assay (mSAT), and a serum immunoglobulin G antibody test using antigens derived from Japanese individuals (S-Ab). This study investigated sensitivity, specificity, likelihood ratios for a positive and a negative test (LR+ and LR-), and accuracy of non-invasive tests, in comparison with invasive tests. Eighty two of 141 patients (58%) were recognized as H. pylori positive by invasive methods. When UBT, mSAT or S-Ab were analyzed, all were found to be effective over 94% accurate. Specificity ranged between 86.7% and 95.8%, and sensitivity ranged between 93.8% and 97.1%. When subjects were stratified into three distinct age groups, the best performance was achieved for 1-6 years old with mSAT at 100% for sensitivity, specificity, and accuracy. S-Ab yielded the best results for children 7-12 years old and the UBT test performed best for 13-18 years old. These results demonstrate the utility of UBT, mSAT, and S-Ab non-invasive tests in diagnosing H. pylori but suggest that certain tests may be optimal for children of distinct ages. Three non-invasive tests, UBT, mSAT and S-Ab showed sufficient sensitivity, specificity and accuracy for the initial diagnosis of H. pylori infection among pediatric patients. Non-invasive tests may contribute to achieving minimum invasive diagnosis with combining with a histological test and a culture test in children.

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。

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。

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──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。

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.

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 。

2种非侵入性检测方法对幽门螺杆菌感染的诊断价值

目的探讨粪便Hp抗原(HpSA)及14 C-尿素呼气试验(14 C-UBT)2种非侵入性检测方法对幽门螺杆菌(Hp)感染的诊断价值。方法采用胃黏膜快速尿素酶法(RUT)和活组织切片染色法联合检测的结果作为Hp感染诊断的"金标准",对2009年1月-2011年6月在新疆医科大学附属中医医院门诊就诊的因上消化道症状接受胃镜检查的132例患者进行粪便Hp抗原(HpSA)及14 C-尿素呼气试验(14 C-UBT)的检测,并与"金标准"进行对比分析。结果 132例患者中RUT法检出Hp阳性95例,组织切片染色法检出Hp阳性92例,其中81例2种方法检测均阳性,将此81例患者作为Hp感染的现症患者,26例2种方法均阴性者作为Hp非感染者。对"金标准"检测的81例Hp阳性患者及26例阴性患者再行HpSA及14 C-UBT检测。以"金标准"作为Hp感染的诊断标准,14 C-UBT检测的敏感性为95.06%(77/81),特异性为92.31%(24/26),阳性预测值为97.47%(77/79),阴性预测值为85.71%(24/28),准确性为94.40%(101/107);HpSA检测的敏感性为91.36%(74/81),特异性为88.46%(23/26),阳性预测值为96.10%(74/77),阴性预测值为76.67%(23/30),准确性为90.65%(97/107)。结论 HpSA及14 C-UBT检测是非侵入性诊断Hp感染的较理想的方法,值得在临床推广,临床医生可根据具体情况选择检测方法,也可以联合运用检测方法来减少假阴性或假阳性结果的出现。

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。

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。

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。

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法在胃肠疾病中的临床诊断价值研究

目的研究幽门螺杆菌粪便抗原(HpSA)检测法在胃肠疾病中的临床诊断价值。方法196例胃肠疾病患者,采集患者的粪便样本以及胃窦区黏膜样本,分别开展HpSA检测法、快速尿素酶试验(RUT)联合组织学检测法。以RUT联合组织学检测结果为金标准,分析HpSA检测法的诊断效能。结果196例患者经RUT联合组织学检测法确诊123例患者感染幽门螺杆菌(Hp),73例未感染Hp,阳性率为62.76%(123/196)。以RUT联合组织学检测法为金标准,HpSA检测法检出阳性患者123例,阳性检出率为62.76%(123/196),灵敏度为97.56%(120/123)、特异度为95.89%(70/73)、阳性预测值为97.56%(120/123)、阴性预测值为95.89%(70/73)、诊断准确率为96.94%(190/196)。结论HpSA检测法在胃肠疾病中的诊断准确率、灵敏度和特异度均较高,可以将该诊断方法应用于儿童、老年人、胃癌家属的筛查中,同时对于不能进行13C-尿素呼气试验(UBT)或14C-UBT、组织学诊断的患者或地区也可以使用该方法。

幽门螺杆菌粪便抗原检测与尿素呼气试验对比研究

目的通过与13C-尿素呼气试验比较,判断幽门螺杆菌粪便抗原检测卡对于幽门螺杆菌感染诊断的准确性。方法采用前瞻性、单盲研究。选择2016年8月—2017年5月在我院体检中心就诊的体检者共231例,分别进行13C-尿素呼气试验(13C-UBT)和幽门螺杆菌粪便抗原(HpSA)检测卡的检查,以13C-UBT作为金标准,来判断HpSA诊断幽门螺杆菌感染的敏感性、特异性、准确度。结果 231例体检者中,13C-UBT检出Hp阳性113例,阳性率为48.92%;HpSA检出Hp阳性110例,阳性率为47.62%。HpSA检测的敏感性为93.8%、特异性为96.6%、阳性预测值为96.4%、阴性预测值为94.2%、准确度为95.2%。结论 HpSA检测卡操作简单、检测快速,能够良好地区分幽门螺杆菌阳性及阴性结果,可作为一种快速简便的幽门螺杆菌非侵入性检测手段。