幽门螺杆菌粪便抗原检测的临床意义

目的评价幽门螺杆菌粪便抗原(HpSA)检测诊断幽门螺杆菌(H.pylori)感染的可靠性.方法收集183例接受内镜检查患者粪便标本,用ELISA法定性检测HpSA.以尿素酶试验和涂片染色联合检测H.pylori作为"金标准”,两者均阳性者为H.pylori感染,均阴性者为无H.pylori感染.结果"金标准”诊断H.pylori阳性120例,阴性63例.120例"金标准”阳性中HpSA检测阳性者为110例,阴性10例.63例"金标准”阴性中HpSA检测阴性者为58例,阳性为5例.HpSA检测的敏感性为91.7%(110/120),特异性为92.1%(58/63),阳性期望值为95.7%(110/115),阴性期望值为85.3%(58/68),总的诊断准确率为91.8%(168/183).结论HpSA检测试验是一种简便、可靠的非侵入性的诊断H.pylori感染的新方法.     

老年人幽门螺杆菌粪便抗原检测的价值

目的 评价一种新的酶联免疫法检测老年人粪便中幽门螺杆菌（helicobacter pylori,Hp）特异抗原的可靠性和临床应用价值。方法 因上消化道症状行胃镜检查的老年患者共199例，其中既往无胃手术史者151例，胃大部切除术后者48例。均行胃粘膜活检，作快速尿素酶试验（RUT）和组织学检查（W－S染色），以RUT和W－S染色为金标准，两项均阳性（或阴性）诊断为Hp阳性（或阴性）。所有患者均检查幽门螺杆菌粪便抗原（HpSA）和^13C－尿素呼气试验（^13C-UBT），分别与金标准比较，计算其敏感性和特异性。结果 经金标准诊断，无胃手术史患者中Hp阳性81例，阴性70例。HpSA检测的敏感性和特异性分别为96.3%和90.0%，^13C-UBT为92.6%和92.9%，两种方法的敏感性和特异性差异无显著性。胃大部切除术后患者中Hp阳性23例，阴性25例，HpSA检测的敏感性和特异性分别为91.3%和88.0%，^13C-UBT为65.2%和92.0%，两种方法敏感性差异有显著性（P＜0.05）。结论 HpSA在诊断老年人Hp感染方面准确、快速、简便，值得推广。对于胃大部切除术后的老年患者，其诊断Hp的敏感性明显优于^13C-UBT。     

幽门螺杆菌诊断方法准确性的影响因素

常用的幽门螺杆菌(H.pylori)诊断方法包括侵入性试验,如快速尿素酶试验(RUT)、组织学检测、培养等和非侵入性试验,如血清学试验、13C和14C,尿素呼气试验(UBT)、聚合酶链反应(PCR)等,各种方法的敏感性和特异性不一。其中组织学检测和培养被作为诊断H.pylori感染的金标准,但也存在一定的缺点。近年来一些新的检测手段不断问世,如H.pylori粪便抗原(HpSA)试验和粪便标本的PCR等。随     

幽门螺杆菌粪便抗原试验的多中心研究

目的：评估幽门螺杆菌（H.pylori)粪便抗原（HpSA)试验诊断H.pylori感染的准确性。方法：应用酶免疫反应原理进行HpSA试验，在大样本、多中心研究中进行HpSA试验的评估。995例因消化不良症状接受胃镜检查者纳入本研究，所有患者均以HpSA试验、快速尿素酶试验（RUT）和组织学（或培养）方法检测H.pylori。以RUT和组织学（或培养）联合检测作为“金标准”，两项试验均阳性者定为H.pylori感染。结果：以光密度值≥0.16为阳性，HpSA检测诊断H.pylori感染的敏感性为93.5%(478/511)，特异性为94.2%(456/484)，阳性预测值为94.5%(478/506)，阴性预测值为93.3%(456/489)，总的检测准确性为93.9%(934/995)。结论：HpSA试验是一种简便、准确的非侵入性H.pylori感染检测方法。     

两种非侵入方法检测幽门螺杆菌感染的临床价值评价

目的对幽门螺杆菌（Hp）粪便抗原和^14C-尿素呼气试验（^14C—UBT）诊断Hp感染的临床价值进行评价。方法以快速尿素酶试验和组织学染色作为“金标准”,两项同时阳性者判定为Hp感染,两项同时阴性者判定为Hp未感染,对Hp阳性和阴性者行Hp粪便抗原（HpSA）和^14C—UBT检测。结果“金标准”诊断Hp感染阳性68例,阴性24例。^14C—UBT诊断Hp的灵敏度为95．6％（65／68）,特异度为87．5％（21／24）,准确度为93．5％（86／92）;HpSA诊断Hp感染的灵敏度为97．1％（66／68）,特异度为91．7％（22／24）,准确度为95．7％（88／92）;^14C—UBT和HpSA联合检测,灵敏度达99．9％,准确度94．6％,而特异度为80．2％。结论HpSA检测是一种简便、易行、准确性高的非侵入性诊断Hp感染方法,^14C—UBT和HpSA两项联合检测可提高检出率。     

幽门螺杆菌粪便抗原检测——一种新的非侵入性诊断方法

目的：评估幽门螺杆菌粪便抗原(HpSA）榆测诊断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。     

两种13C-尿素呼气试验试剂诊断幽门螺杆菌感染临床可靠性比较

^13C-尿素呼气试验快捷、无创伤，敏感性和特异性高。在临床上被广泛应用于幽门螺杆菌(H.pylori)感染的检测。从加拿大进口的^13C-尿素试剂已获得国家食品药品监督管理局许可并应用于临床。目的：与加拿大进口的^13C-尿素试剂进行比较，评估美国Isotec公司生产的^13C-尿素试剂用于诊断H.pylori感染的临床可靠性。方法：114例因上消化道症状接受胃镜检查者随机分为A、B两组。取胃窦活检标本分别作快速尿素酶试验、组织学检查和H．pylori培养．三项中有两项或以上阳性，或H．pylori培养单项阳性判为H．pylori感染，否则判为无H．pylori感染。以此作为诊断H．pylori感染的金标准。A组使用加拿大进口的^13C尿-素试剂，B组使用美国Isotec公司生产的^13C-尿素试剂，分别进行^13C-尿素呼气试验。根据金标准分别计算和比较两组^13C-尿素呼气试验的准确性、敏感性、特异性和阳性预测值、阴性预测值。结果：A组^13C-尿素呼气试验诊断H．pylori感染的准确性为92．8％，敏感性为94．1％，特异性为90．9％，阳性预测值为94．1％，阴性预测值为90．9％；B组准确性为98．3％。敏感性为96．9％，特异性为100％，阳性预测值为100％，阴性预测值为96.3％。两组上述各项指标均无显著差异。结论：A组和B组^13C-尿素呼气试验诊断H．pylori感染的准确性、敏感性、特异性和阳性预测值、阴性预测值均较高．美国Isotec公司生产的^13C-尿素试剂用于临床诊断H．pylori感染结果可靠。     

商用血清学试剂盒诊断幽门螺杆菌现症感染的应用评估

背景：寻找操作简便的非侵人性检测方法对于幽门螺杆菌（H．pylori）现症感染的诊断非常重要。目的：评估应用胶体金免疫层析技术的商用血清学试剂盒在诊断H．pylori现症感染中的应用价值。方法：167名健康志愿者纳入本研究。采集血标本，以Assure H．pylori快速检测试剂盒行免疫层析。同时行^13C-尿素呼气试验（^13C-UBT）和内镜活检组织病理学检查，两项检查均阳性定义为H．pylori感染，两项检查均阴性定义为H．pylori阴性。结果：根据诊断标准．147例纳入统计分析者的H．pylori感染率为65．3％，Assure H．pylori快速检测的现症感染阳性率为68．7％．其诊断敏感性、特异性、阳性预测值、阴性预测值和准确性分别为96．9％、84．3％、92．1％、93．5％和92．5％。结论：Assure H．pylori快速检测是一种简单、快速、可靠的非侵人性H．pylori现症感染诊断方法，在流行病学调查中有很好的应用前景。     

^14C尿素呼气试验检测幽门螺杆菌感染在老年人疾病诊断中的应用探讨

目的：探讨^14C尿素呼气试验(urea breath test，UBT)检测幽门螺杆菌(H．pylori)感染在老年人消化道疾病、急性冠脉综合征(ACS)诊断中的意义。方法：用自身对照的方法比较30例消化道疾病患者内镜活检快速尿素酶试验H．pylori阳性与UBT阳性、血清学阳性情况，20例血清学H．pylori抗体阳性的ACS患者与UBT、内镜阳性情况。结果：消化道疾病组内镜活检H．pylori阳性者做UBT的阳性率为93％，血清学阳性95％，血清学H．pylori阳性的ACS者做UBT的阳性率为50％，不稳定心绞痛者症状消失10d后查内镜H．pylori阳性率为42％。结论：用UBT诊断老年人与H．pylori感染有关的疾病安全可靠。     

14C-尿素呼气试验对幽门螺杆菌感染的诊断价值

目的：评估^14C-尿素呼气试验（^14C-UBT）对幽门螺杆菌（HP）感染的诊断价值。方法：对2000例1月内未曾使用可能影响HP检测结果的药物者同步完成快速尿酶试验（RUT）、病理、^14C-UBT检测，以病理（HE染色）、RUT均阳性为诊断HP感染的标准，评价^14C-UBT对HP感染的诊断价值。结果：^14C-UBT的敏感性89.7％，特异性98.4％，阳性预测值98.4％，准确性93.4％，阴性预测值88.1％。结论：^14C-UBT是HP感染无创伤、敏感而特异的诊断方法。     

Helicobacter pylori stool antigen (HpSA) test--a simple, accurate and non-invasive test for detection of Helicobacter pylori infection

BACKGROUND/AIMS: To access the reliability of a newly developed test, the Helicobacter pylori (H. pylori) stool antigen (HpSA) test was used for detection of H. pylori infection. METHODOLOGY: Stool specimens were collected from 33 consecutive patients (19 males and 14 females, age range: 16-73 years, mean: 49 years) who received upper gastrointestinal endoscopic examination for gastrointestinal symptoms. The H. pylori status was evaluated based on six different tests: culture, histology, biopsy urease test, 13C-urea breath test (13C-UBT), serology, and HpSA test. A commercial kit using an enzyme-linked immunosorbent assay examined HpSA in the stool. H. pylori status was defined as positive when the culture was positive or concordance of three of the other four tests (histology, biopsy urease test, 13C-UBT, and serology) was positive. RESULTS: Twenty patients were diagnosed as H. pylori-positive. The HpSA test was positive in 19 patients and negative in 14 patients. The sensitivity and specificity were 95.0% and 100%, respectively. The overall accuracy rate was 96.3%. CONCLUSIONS: The HpSA test is a new, simple, non-invasive method for accurate diagnosis of H. pylori infection.     

Diagnosis of Helicobacter pylori infection by stool antigen test in southern Taiwan

Helicobacter pylori (H. pylori) has been found to be associated with various gastrointestinal diseases. Confirmation of H. pylori infection includes invasive and non-invasive methods. There has been increasing interest in noninvasive tests recently. However, the geographical differences among H. pylori strains have been emphasized recently and the H. pylori strain in Taiwan showed a high cagA positive result and different vacA subtype when compared with those of Western countries. The aim of this study is to access and compare the reliability and the diagnostic accuracy of the stool H. pylori antigen tests by spectrophotometry and by the visual method, especially in Southern Taiwan. Thirty-two patients (18 men and 14 women; age range: 23-91 y/o, mean: 50.5 y/o) who underwent gastroendoscopy at Kaohsiung Medical University Hospital were enrolled in this study. H. pylori infection status was confirmed by culture or two positive test results on CLO test, histology and 13C-urea breath test (13C-UBT). The exclusion criteria included previous gastrointestinal tract surgery, use of antibiotics, proton pump inhibitor or compounds containing bismuth within 1 month of the study. Among them, 14 patients were with duodenal ulcer (DU), 4 with gastric ulcer (GU), 12 with non-ulcer dyspepsia, and 2 with GU and DU. Those patients had their stool collected for ELISA tests of H. pylori stool antigen (HpSA). The HpSA tests were positive in 16 of 18 patients diagnosed as H. pylori positive, and negative in 13 of 14 patients as H. pylori negative. The sensitivity and specificity were 88.9% and 92.9% respectively. The positive and negative predictive values were 94.1% and 86.7% respectively. The concordance of HpSA accessed by spectrophotometry and visual method is 100%, which makes this test even easier and cheaper. We concluded that stool HpSA test is a noninvasive, accurate, reliable, rapid and easy way to diagnose H. pylori infection in Southern Taiwan, either by spectrophotometry or by visual assessment.     

Evaluation of the Helicobacter pylori stool antigen test (HpSA) for detection of Helicobacter pylori infection in children

OBJECTIVE: Helicobacter pylori (H. pylori) infection is usually acquired in early childhood. Noninvasive methods for detection of H. pylori infection are required to study its incidence, transmission, and clearance. They should be easy to perform, inexpensive, and have a high diagnostic accuracy, especially in infants and toddlers. Both serology and the 13C-urea breath test (13C-UBT) do not fulfill all these requirements. The aim of this study was to evaluate a new enzyme immunoassay for detection of H. pylori antigen in stool (Premier Platinum HpSA, Meridian Diagnostics, Cincinnati, OH) in a large cohort of children and to compare it to invasive techniques and the 13C-UBT. METHODS: HpSA was performed in 310 stool samples of 274 children divided into three groups. Group A consisted of 145 children and adolescents (0.5-19.8 yr, 66/145 <6 yr) who underwent upper endoscopy for various gastrointestinal symptoms. H. pylori status was defined by histology, culture, and rapid urease test from biopsies of the antrum and corpus. A 13C-UBT was performed in 133 of 145 children. Group B consisted of 22 patients (5.7-16.1 yr) who were retested with both noninvasive tests 8 wk after anti-H. pylori triple therapy. Group C consisted of 129 healthy infants and toddlers (0.9-3.1 yr) who were tested with the 13C-UBT. Children with discrepant or positive test results were retested after 2 and 12 months. Results of the HpSA were read at 450/620 nm by spectrophotometry. An optical density <0.100 was defined as negative, >0.120 as positive, and values between 0.100 and 0.120 were considered as equivocal. RESULTS: In Group A, the HpSA gave false-negative results in five of 45 infected children and false-positive results in four of 100 noninfected children, whereas four patients (2.8%) showed equivocal results. In both infected and noninfected children, no relation between the optical density values and age was found. The 13C-UBT was correct in 132 of 133 children tested. In Group B, there was complete concordance between the HpSA and 13C-UBT: 19 children tested negative and three positive. In Group C, concordant results between the two noninvasive methods were found in 124 of 129 (96%) toddlers (122 negative and two positive). Retesting of five children with discrepant results revealed that, on initial testing, the HpSA was incorrect in two (one false-positive, one false-negative), and the 13C-UBT was incorrect in three (always false-positive). CONCLUSIONS: In symptomatic children, the HpSA revealed a sensitivity of 88.9% (95% CI 77.3-96.3) and a specificity of 94.0% (88.1-97.7) compared to the 13C-UBT, 100% (94.0-100) and 98.9% (94.7-100), respectively. However, in healthy toddlers, the HpSA performed as well as the 13C-UBT with excellent concordance between the two noninvasive tests. There was no age dependency of the stool test results, and changing the cutoff would not have improved accuracy. Thus, the HpSA test seems suitable to monitor the success of anti-H. pylori therapy.     

Validity of a Helicobacter pylori stool antigen assay for the assessment of H. pylori status following eradication therapy.

BACKGROUND: A Helicobacter pylori stool antigen (HpSA) test has been proposed as a valid alternative to the 13C-urea breath test (13C-UBT) for the non-invasive detection of H. pylori infection in primary diagnosis. Published reports show conflicting results with regard to the test's diagnostic accuracy after eradication therapy. The aim of the present study was to assess the diagnostic value of the HpSA test and to determine the optimal discriminating cut-off value in patients following H. pylori eradication therapy. METHOD: Stool samples were collected and the 13C-UBT was performed in 113 patients 4-6 weeks after eradication therapy. A validated test protocol for the 13C-UBT was used. Stool specimens were analysed with the Premier Platinum HpSA enzyme immunoassay (EIA). A receiver operator characteristics (ROC) analysis was performed to define the optimal cut-off value on the basis of the results of the 13C-UBT. RESULTS: The results of the 13C-UBT showed that H. pylori eradication was successful in 83/113 (73%) patients. According to the manufacturer, the cut-off value for the HpSA test is 0.14 optical density, but this does not appear to be valid after eradication therapy (sensitivity 76.7%, specificity 98.8%). On the basis of ROC analysis, the optimal cut-off value after therapy was determined to be 0.11 optical density, giving a sensitivity of 93.3% and a specificity of 93.9%. CONCLUSION: The HpSA test is a valid test for the assessment of H. pylori status after eradication therapy, provided an adjusted cut-off value is applied.     

Detecting Helicobacter pylori infection in hospitalized frail older patients: the challenge

OBJECTIVES: Helicobacter pylori infection has not been well studied in older people, especially in hospitalized, frail patients. The aim of our study was to evaluate the prevalence of the infection in this population using five H. pylori diagnostic tests. DESIGN: Prospective observational study. SETTING: Geriatric acute care unit of the Department of Geriatrics (H?pital Xavier Arnozan, Pessac, France). PARTICIPANTS: One hundred seven consecutively hospitalized patients with a diagnostic indication for upper gastrointestinal endoscopy. MEASUREMENTS: Geriatric assessment, information on drug intake, indication/results of gastric endoscopy, and results of H. pylori infection diagnostic tests (culture and histological analysis on biopsy specimens, serology, 13carbon-urea breath test (13C-UBT), detection of H. pylori stool antigens (HpSA)) were assessed for each included patient. RESULTS: Fifty-one patients (47.7%) were H. pylori positive with at least one test. 13C-UBT was more frequently positive than the other four tests, with a significant difference from culture, histological analysis, and HpSA (P <.05). Positive 13C-UBT results were significantly associated with H. pylori presence using histological analysis and neutrophil activity of the antrum and corpus. Antibiotic treatments significantly decreased the positivity rate of all of the tests performed, and severe corpus atrophy decreased the positivity rate of culture, histological analysis, and HpSA. CONCLUSIONS: Almost one-third of the H. pylori-positive patients would have remained undetected without performing the 13C-UBT. The low prevalence of H. pylori detection in these hospitalized, frail patients may be explained by the high frequency of current and previous antibiotic treatments.     

Accuracy of Helicobacter pylori stool antigen for the detection of Helicobacter pylori infection in dyspeptic patients

AIM: The premier platinum Helicobacter pylori (H pylori) stool antigen (HpSA) test is an enzyme immunoassay (EIA) that detects an H pylori antigen present in human stools. However, at present there is no uniformity about the cut off level required to consider the test as positive or negative. So we need the cut off level for our local population. The aim of this study was to evaluate the HpSA for the detection of H pylori infection in dyspeptic patients and to determine the sensitivity, specificity of the HpSA test in the diagnosis of H pylori infection, as compared to other standardized diagnostic techniques. METHODS: Sixty-three dyspeptic patients were selected from patients who came to the Division of Gastrointestinal Clinic in Cipto Mangunkusumo Hospital, Jakarta, Indonesia. H pylori infection was confirmed in all patients by histology and rapid urease test (CLO test). Positive results for H pylori were based on positive results from both rapid urea test and microscopic detection of H pylori. Stool specimens were analyzed for H pylori antigen using HpSA immunoassay. RESULTS: A total 63 patients consisted of 31 (49.2%) males and 32 (50.8%) females ranging in ages between 16 and 73 years with a mean age of 42.4+/-15 years. The mean age of men was 43.2+/-15.7 years and women was 41.6+/-14.4 years. Endoscopic findings in this study included gastric cancer 1.6%, peptic ulcer 4.8%, duodenal ulcer 7.9%, esophagitis 6.3%, gastritis 77.7%, and gastroduodenitis 4.8%. According to the predefined study criteria, 6 (9.5%) of 63 patients were positive for H pylori. In the diagnosis of infection, the area under the receiver operating characteristic (ROC) curve for the HpSA test was 0.722 (95% CI, 0.518-0.927). Using a cut-off value of 0.274 instead of 0.16 (as recommended by the manufacturer) the sensitivity and the specificity were 66.7% and 78.9% respectively. CONCLUSION: The HpSA stool test, using a cut-off value of 0.274, may be useful for the primary diagnosis of H pylori infection, its specificity is similar to other standard tests but its sensitivity was lower.     

~(14)C-呼气试验检测幽门螺杆菌感染

本文应用国产~(14)C-呼气试验(~(14)C-UBT)试剂检测幽门螺杆菌(Hp)。同时应用病理组织染色、尿素酶试验、细菌培养和血清 ELISA 技术等方法与之进行比较。117例病人中 Hp 阳性率为47.9%(56/117),~(14)C-UBT的敏感性与特异性分别为94.6%和93.4%。~(14)C-UBT 由于相对于胃镜依赖的方法而言创伤性大大降低,是目前检测 Hp 感染,尤其是药物治疗后复查时的首选方法。     

<Emphasis Type="Italic">Helicobacter pylori</Emphasis> Stool Antigen (HpSA) Tests in Children Before and After Eradication Therapy: Comparison of Rapid Immunochromatographic Assay and HpSA ELISA

The rapid immunochromatography for Helicobacter pylori (H. pylori) stool antigen (rapid HpSA) test is a recently-developed method for detection of H. pylori infection. The objective of this study was to assess the pre and post-eradication diagnostic accuracy of the rapid HpSA test compared with the conventional HpSA immunoassay (HpSA ELISA) in children. Sensitivity, specificity, positive predictive value, and negative predictive value for the rapid HpSA test were 94.6, 98.4, 94.6, and 98.4%, respectively, and those for the HpSA ELISA were 94.6, 96.1, 87.5, and 98.4%, respectively. No significant difference was observed between the sensitivity and specificity of the two HpSA tests in children (P = 1.000 and P = 0.250) or the sensitivity and specificity of the two HpSA tests pre and post-eradication therapy (P = 1.000 and P = 1.000). The rapid HpSA and HpSA ELISA are reliable methods of detection of H. pylori infection in the pediatric population before and after eradication therapy.