胃大部切除术后患者幽门螺杆菌感染诊断方法的评估

目的：评估胃大部切除术后患者中幽门螺杆菌(Hp）感染状态和两种常用诊断方法（^14C-尿素呼气试验、快速尿素酶试验）的准确性，方法：用培养、组织学、^14C-尿素呼气试验（^14C-UBT)和 快速尿素酶试验（RUT）四种方法同时对胃大部切除术后患者进行Hp感染的诊断，以培养和组织学联合诊断作为“金标准”，评估^14C-UBT和RUT的准确性，以非手术者作对照，评估胃大部切除术患者的Hp感染率。结果：37例胃大部切除术后患者（Billroth Ⅰ或17例和BillrothⅡ式20例）的Hp总阳性率为29．7％，BillrothⅠ式（29．4％）和Ⅱ式（30．0％）患者间Hp阳性率差异无显著性（P＞0．05）。RUT敏感性为72．7％，特异性为57．7％，准确性为62．2％，^14C-UBT敏感性为63．6％，特异性为100．0％，阴性预示值86．7％，。对照组Hp阳性率为71．4％。结论：胃大部切除术后患者Hp感染率低，RUT特异性低，^14C-UBT敏感性低，因此均不适用于胃大部切除术后患者Hp感染的诊断。     

幽门螺杆菌粪便抗原试验检测幽门螺杆菌感染的临床评价

目的 评价一种新的酶免疫法——幽门螺杆菌(HP)粪便抗原(HPSA)试验检测HP感染和监测HP根除治疗的可靠性。方法 未接受过抗HP治疗的患者分为2组，A组331例，无胃部手术史；B组65例，胃大部切除术后。2组患者因上消化道症状而接受胃镜检查，以胃黏膜活检标本快速尿素酶试验(RUT)和组织学检查(W-S染色)联合检测HP作为“金标准”，对HPSA试验的准确性进行评价，并与另一非侵入性的^13C-尿素呼气试验(^13C-UBT)加以比较。此外，A组中HP阳性的56例患者(C组)给予三联根除治疗1周，分别于停药后第1、7、14、21、28天收集粪便标本进行HPSA测定。于停药后第28天测定^13C-UBT，并以此为标准，评价HPSA试验的准确性。结果 A组患者经“金标准”诊断HP阳性175例，阴性156例。HPSA试验的敏感性为95，4％，特异性为91．0％，与^13C-UBT比较差异无统计学意义。B组患者中，经“金标准”诊断HP阳性30例，阴性35例。月psA试验敏感性为90．0％，^13C-UBT的敏感性为66．7％。HPsA试验的敏感性明显优于^13C-UBT(P＜0．05)。C组患者于停药后第28天经^13C-UBT诊断HP阳性16例，阴性40例。HPSA于停药后第1天54例阴性，此后随时间推移，未成功根除病例陆续转为阳性，而成功根除病例仍大部分保持在阴性范围，仅少数病例出现假阳性。停药后第28天的准确性最高(92．9％)。结论 HPSA试验是一种可靠的非侵入性检测方法，对于抗HP治疗前、后患者HP感染的诊断均有较高的准确性。对于胃大部切除术后的患者亦有较高的诊断价值。     

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。     

^13C—尿素呼气试验诊断幽门螺杆菌感染的研究

目的评估13C-尿素呼气试验（13C-UBT）幽门螺杆菌（Hp）感染的可靠性。方法对82例因胃病而行胃镜检查的患者，于胃窦和胃体取多个活检标本作组织学、粘膜涂片和快速尿素酶试验，以决定是否感染Hp，并作13C-UBT。结果13C-UBT的敏感性、特异性、阳性预测值、阴性预测值是与组织学和尿素酶方法检测Hp的检测结果比较而计算得到。13C-尿素呼气试验的敏感性97．92％、特异性100％、阳性预测值100％、阴性预测值97．14％、准确性98．78％。结论13C-尿素呼气试验有高度敏感性和特异性，对确定患者的Hp感染状态是一非常可靠而又无创伤的诊断方法。     

现症感染条带检测对儿童幽门螺杆菌感染的诊断价值

目的评价现症感染条带（CIM）检测诊断儿童幽门螺杆菌（Hp）感染的价值。方法对102例有上消化道症状的患儿行胃镜检查并取胃窦黏膜活检,分别经快速尿素酶试验（RUT）及免疫组化染色检测Hp;在胃镜检查前分别行13C-尿素呼气试验（13C-UBT）和CIM血清学检测Hp。以13C-UBT为金标准,评价CIM诊断Hp感染的敏感性、特异性和准确性。结果 CIM诊断Hp感染的敏感率高于RUT及免疫组化染色（P均〈0.05）,特异率高于RUT（P〈0.05）。结论 CIM可作为诊断儿童Hp现症感染的有效检测手段。     

幽门螺杆菌粪便抗原检测在幽门螺杆菌感染诊断及随访中的价值

目的 对幽门螺杆菌粪便抗原（HpSA）检测诊断hp感染、hp根除治疗后的随访及在儿童中的应用价值，进行临床评价。方法 以快速尿素酶试验=、组织学和细菌培养中的二项阳性或细菌培养一项阳性作为诊断HP的金标准，采用ELISA法检测128例因上消化道症状接受胃镜检查患者HPSA，评价HPSA诊断HP感染的敏感性、特异性；其中79例同时进行^13C-UBT作为对照，评价HPSA诊断HP感染的准确性。结果 在128例中，HPSA检测的敏感性、特异性和准确性分别为95.16%，98.41%和96.80%。根除治疗前HPSA检测和^13C-UBT诊断HP的敏感性为97.96%和95.92%，特异性为96.67%和100.00%，准确性均为97.46%；根除治疗后4周随访HPSA检测和^13C-UBT的敏感性均为100.00%，特异性为91.43%和94.29%，准确性 93.18%和95.45%。以^13C-UBT作标准，HPSA检测29例患儿HP感染敏感性、特异性和准确性分别为91.67%，88.23%和89.66%。结论 HPSA检测是一种简便、准确、非侵入性的诊断HP感染的方法，适用于HP感染的诊断、根除治疗后随访及儿童患者。     

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。     

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^14C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 ^14C呼气试验和HpSA同时阳性者38例，^14C呼气试验阳性而HpSA阴性者4例；^14C呼气试验和HpSA同时阴性者57例，^14C呼气试验阴性而HpSA阳性1例。以^14C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^14C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人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。     

幽门螺杆菌根除治疗前后快速尿素酶试验诊断的准确性

目的 评价快速尿素酶试验(RUT)在根除治疗前后诊断幽门螺杆菌(Hp)感染的准确性。方法 选择250例接受胃镜检查的患者，123例无Hp根除治疗史，127例为Hp根除治疗后复查患者。每例患者取胃窦和胃体活检标本各3块，分别用于RUT、细菌培养和病理组织学检查。以细菌培养及病理组织学检查结果作为“金标准”，即培养和(或)组织学检查结果阳性者为Hp阳性，而培养和组织学检查结果同时阴性者为HP阴性或HP根除。结果 末行Hp根除治疗的患者RUT正确的诊断了86例Hp阳性中的84例和37例Hp阴性中的34例，其敏感性和特异性分别为97．7％和91.9％。根除治疗后RUT敏感性和特异性分别为64.3％和99.0％。然而，根除治疗后6个月以上复查胃镜，RUT敏感性和特异性均达100％。结论 根除治疗前和根除治疗后6个月以上复查，RUT诊断Hp感染准确性高。     

幽门螺杆菌粪便抗原快速检测在幽门螺杆菌感染诊疗前后应用的初步评价

目的 评估幽门螺杆菌(Hp)粪便抗原(HpSA)快速检测卡在Hp感染诊疗前后的临床应用价值.方法 用HpSA快速免疫检测卡检测217例(A组)患者的粪便标本,以快速尿素酶试验、病理组织学染色、13C尿素酶呼气试验(13C-UBT)联合检测结果作为"金标准"评价HpSA试验的准确性,并从中选择符合"金标准"Hp阳性的患者78例(B组),治疗后复查HpSA检测及13C-UBT,并以13-UBT结果为标准检测HpSA试验的准确度.结果 A、B两组HpSA检测敏感度分别为92.9%、90.0%;特异度为94.4%、94.8%;阳性预测值为95.9%、85.7%;阴性预测值为90.4%、96.5%;准确率为93.5%、93.5%.结论 HpSA快速检测卡试验对抗Hp感染诊疗前后均有较高的准确性.     

幽门螺杆菌感染诊断方法的比较

338例病人同时进行了快速尿素酶试验(简称RUT)。Warthin-Starry染色(简称W-S染色)、培养法、~(13)C-尿素呼气试验(~(13)C-UBT)、血清IgG、IgM等6种诊断方法中任意3种检查,以同时2种(或以上)检查方法一致的结果作为诊断幽门螺杆菌(Hp)是否存在的标准。对上述6种方法的敏感性、特异性、符合率、阳性预测值、阴性预测值分别给予评价,结果显示:RUT、W-S染色、~(13)C-UBT三法诊断Hp的敏感性、特异性等较高,均接近或高于90％。     

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.     

Diagnostic accuracy of (13)C-urea breath test in the diagnosis of Helicobacter pylori infection in patients with partial gastric resection due to peptic ulcer disease: a prospective multicenter study

AIMS: We investigated the diagnostic properties of the (13)C-urea breath test ((13)C-UBT) prospectively. These are well validated in nonresected patients before and after treatment of Helicobacter pylori infection but not in patients with partial gastric resection due to peptic ulcer disease. METHODS: Hospitalized patients with previous gastric resection and indications for upper gastrointestinal endoscopy were recruited for the study. Biopsy specimens were obtained from the fundus mucosa and the gastric remnant adjacent to the gastroenteric anastomosis for histological examination and rapid urease test (HUT test). Histological slides were evaluated after hematoxylin and eosin and Warthin-Starry dye staining. 200 ml orange juice was given orally after two baseline breath samples had been taken, and 30 min after ingestion of 75 mg (13)C urea two more breath samples were obtained and analyzed by ratio mass spectrometry. The Warthin-Starry dye-stained sample was taken as reference. RESULTS: 68 patients (47 male, 21 female, mean age 62 years; 52 Billroth II resection, 17 Billroth I resection) were included in the study. The overall prevalence of histologically proven H. pylori infection was 36.7%. The sensitivity of the (13)C-UBT was 52%, the specificity 93%. The positive predictive value was 81.25%, the negative predictive value 76.9% and the accuracy was 77.9%. The sensitivity of the HUT test reached 60%, and the specificity 97%. CONCLUSION: The diagnostic accuracy of (13)C-UBT compared with the Warthin-Starry dye staining is low. The breath test, performed in the above-described manner, cannot be recommended as a noninvasive diagnostic tool for diagnosis of H. pylori infection in patients after partial gastrectomy as a result of peptic ulcer disease.     

Accuracy of an enzyme immunoassay for the detection of Helicobacter pylori in stool specimens in the diagnosis of infection and posttreatment check-up

OBJECTIVE: The aim of this study was to assess the reliability of a newly developed enzyme immunoassay for Helicobacter pylori-specific antigen detection in stools (HpSA) compared to other standardized diagnostic techniques such as histology (H), rapid urease test (RUT) and 13C-urea breath test (UBT) to diagnose H. pylori infection and to evaluate its usefulness in determining H. pylori status after treatment. METHODS: One hundred eighty-eight patients referred to our department for upper gastrointestinal endoscopy were included. H. pylori infection was confirmed in all patients by HpSA test in stools, RUT, UBT, and H. Patients were defined as positive for H. pylori if RUT and UBT or H were positive. A total of 142 symptomatic patients received eradication treatment and were reassessed 6 wk after therapy; for 70 of these patients, stool samples were also collected at 24 h and 6 months after finishing eradication treatment. In the posttreatment follow-up, UBT was used as gold standard. RESULTS: The sensitivity of HpSA test for the diagnosis of H. pylori infection using a cut-off value of 0.130 was 89.5% and its specificity 77.8%. This specificity was lower than that obtained with UBT, H, and RUT. In the early follow-up the sensitivity of HpSA test was null. At 6 weeks and at 6 months post-treatment its sensitivity was 70.4% and 50% and its specificity was 81.6% and 79.3%, respectively. CONCLUSIONS: The HpSA stool test, using a cut-off value of 0.130, may be useful for the primary diagnosis of H. pylori infection, with sensitivity similar to that obtained with other standard tests, but with less specificity. HpSA test is not useful for early monitoring of treatment efficacy. At 6 wk and at 6 months posttreatment, HpSA test lacks accuracy as compared to UBT for evaluating the outcome of the eradication treatment.     

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.     

How to determine the diagnosis of Helicobacter pylori infection in the elderly?

PURPOSE: The real prevalence of Helicobacter pylori (H. pylori) infection is difficult to determine in the elderly because of the frequency of drug intake (antibiotics or anti-secretory drugs). The aim of this study was to evaluate the diagnostic performance of five tests in the elderly. METHODS: The study population consisted of consecutive patients undergoing a routine endoscopy between August 1998 and December 1999. We evaluated the diagnostic performance of four tests in all of the included patients: culture and histology of biopsy specimens, serology (ELISA) and urea breath test (13C-UBT). Detection of H. pylori antigens in stool samples (HpSA) was realized in a subgroup. Patients were considered H. pylori + when result for culture was positive or when two tests were positive. RESULTS: One hundred and sixty-seven patients were included in this study (55 men, 112 women; mean age: 85.6 +/- 5.1 years). Only 38 (22.8%) patients were H. pylori+. Test performances showed the following results: serology sensitivity: 90.9% (IC 95%: 75.6-98.1) versus 86.9% (IC 95%: 63.6-96.9) for culture versus 77.8% (IC 95%: 60.8-89.9) for histology and 74.3% (IC 95%: 56.7-87.5) for 13C-UBT. Eighty-nine (53.3%) took antibiotics or anti-secretory drugs, only 13C-UBT performances decreased significantly (sensitivity: 94.4% [72.7-99.8] versus 52.9% [27.8-77]; P < 10(-6)). When gastric or duodenal ulcer were endoscopically diagnosed in older patients, both histology and 13C-UBT could not improve the diagnosis of H. pylori infection. HpSA was realized in 107 patients (sensitivity: 74.1%, specificity: 98.7%). We showed no statistical difference between HpSA performances and drug intake. CONCLUSION: Diagnostic performances decreased in older patients especially because of drug intake.     

微量14C-尿素呼吸试验诊断幽门螺杆菌感染的评价

目的 研究＾１４Ｃ－尿素呼吸试验（ＵＢＴ）诊断幽纱杆菌感当的应用价值。方法 对１１９例有上消化道症状而就医的患者同时做＾１４Ｃ＝尿素呼吸试验。快速尿素酶试验（ＲＵＴ）。组织切片Ｗａｒｔｈｉｎ－Ｓｔａｒｒｙ银染色。将上述三种方法的敏感度,特异度、准确度加以比较。结果 ＾１４Ｃ－ＵＢＴ的特异度高于ＲＵＴ,三者的准确度比较无显著性差异,结论＾１４Ｃ－ＵＢＴ具有简便,可靠、、无交叉感洒及无创伤性等优点。     

Lack of accuracy of the noninvasive Helicobacter pylori stool antigen test in patients with gastroduodenal ulcer bleeding

OBJECTIVE: Oral presentation at Digestive Diseases Week, San Francisco, California, May 2002. The antigen-based stool assay has proven to be accurate in diagnosing Helicobacter pylori infection in dyspeptic patients. We evaluated the H. pylori antigen-based stool assay (HpSA) in patients with peptic ulcer bleeding (PUB). METHODS: Thirty-six patients with PUB were endoscoped, and antral and corpus biopsy specimens were taken for rapid urease test (RUT), histology, and culture. The first stool sample after admission was collected for the HpSA test. The gold standard was defined as either positive culture or positive RUT and histology. If only RUT or histology was positive, this was defined as indeterminate. To evaluate cross-reaction with blood constituents, citrated blood samples from 10 healthy volunteers (nine H. pylori serology negative and one H. pylori serology positive) were assessed by the HpSA test. RESULTS:A total of 36 consecutive patients with PUB (21 male) with a mean age of 69.5 yr were included in the study. Using the gold standard, the sensitivity and specificity of the HpSA test were 100% and 52%, respectively. Citrated blood samples of three H. pylori negative and one H. pylori positive volunteer gave a positive result in the HpSA test, suggesting cross-reaction with blood con stituents. CONCLUSIONS: The HpSA test gave a high number of false- positive results in patients with PUB, probably because of blood constituents cross-reacting in the enzyme immunoassay. The HpSA test is not accurate for testing H. pylori infection in patients with PUB.     

Evaluation of 13C-urea breath test to confirm eradication of Helicobacter pylori]

This study aimed to evaluate the effectiveness of the 13C-urea breath test (UBT) for assessment of Helicobacter pylori eradication after treatment. One hundred twenty six patients were enrolled with 85 receiving proton pomp inhibitor based triple therapy. They were underwent upper gastrointestinal endoscopy with biopsies for diagnosis and assessment of H. pylori infection using culture, histology, rapid urease test (RUT) and 13C-UBT. Assessment of eradication needs to be performed 4 weeks or more after completion of treatment. Breath samples were taken 15 minutes after the ingestion of 100 mg 13C-urea. Breath samples were analyzed on a mass spectrometer system. The gold standard for H. pylori infection was a positive culture or positive histology + positive RUT; negative for infection was defined as negative results of all three biopsy tests. Based on ROC curves, the most appropriate cut-off value for diagnosis of H. pylori infection was identified as 2.5/1000, which provided 96.2% sensitivity, 100% specificity, and 96.8% accuracy as judged by the gold standard. However, when confirming the eradication of H. pylori, it was 3.5/1000, which provides for 100%, 95.8%, and 96.5%, respectively. Ten patients (11.8%) had delta13C values that were 2.5-5.0/1000 4-12 weeks after therapy. Eight patients were considered cured of H. pylori infection, and 2 were considered to still have H. pylori infection following 13C-UBT, serology, and H. pylori specific antigen test. The false-positive rate of 13C-UBT was 9.4% (8/85). When the grey zone of 13C-UBT was set at a level of 2.5 to 5.0/1000 (2.5 > : negative, 5.0 < or = : positive) after eradication therapy, the sensitivity and specificity of 13C-UBT was 100% and 98.4% compared to the gold standard. It was concluded that to avoid false-positive results of 13C-UBT, the grey zone of 13C-UBT needs to be set at a level of 2.5 to 5.0/1000; thus improving the accuracy of test for the assessment of eradication of H. pylori infection.