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。     

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.     

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。     

Clinical value of stool Helicobacter pylori antigen test in patients with gastrointestinal diseases

正Objective To investigate the value of stool Helicobacter pylori antigen test(Hp SA)in the diagnosis of Hp in patients with gastrointestinal diseases.Methods The totals of 142 patients who came to our hospital due to gastrointestinal symptoms were selected as the subjects from April 2015 to May 2016.Everyone accepted the     

Discrepancy between Helicobacter pylori stool antigen assay and urea breath test in the detection of Helicobacter pylori infection.

BACKGROUND: The reference diagnostic methods available for detection of Helicobacter pylori infection are either invasive (histology) or expensive and highly sophisticated (Urea Breath Test). A new enzyme immunoassay, which can be easily performed in any laboratory, has been developed to detect Helicobacter pylori in stool specimens (HpSA-Meridian Diagnostics, Cincinnati, USA). Aim of the study was to compare HpSA to Urea Breath Test. PATIENTS AND METHODS: A total of 125 patients (52 never treated for Helicobacter pylori infection and 73 after Helicobacter pylori eradication therapy) referring to our Department, underwent both tests within two weeks. RESULTS: Contrasting results between the two tests were found in 30% of cases: in 19% of the untreated patients and in 37% of the treated patients (p<0.001). The main discrepancy consisted in positive HpSA associated with negative Urea Breath Test. Mean HpSA value in such conditions was 0.273 optical density, while in patients with both positive tests, it was 1.192 optical density. In untreated, but not in treated patients, raising the HpSA cut off value significantly decreased the percentage of conflicting results. CONCLUSIONS: Some disagreement was detected between HpSA and Urea Breath Test results, especially in treated patients. Possible explanations for our findings are a low HpSA cut off value together with the identification of Helicobacter pylori coccoid forms by the immunoassay but not by the urease based Urea Breath Test. The higher percentage of discrepancy detected in treated patients might support this hypothesis.     

Evaluation of Helicobacter pylori stool antigen test before and after eradication therapy

BACKGROUND AND AIM: The Helicobacter pylori stool antigen (HpSA) test is useful for initial diagnosis of H. pylori infection, but there is disagreement regarding its diagnostic accuracy after eradication therapy. The aim of the present study was to evaluate the diagnostic accuracy of the HpSA test before and after eradication therapy. METHODS: One hundred and thirty-six patients underwent upper gastrointestinal endoscopy with biopsies for the diagnosis of H. pylori infection using culture, histology and the rapid urease test. Fifty-four H. pylori-positive patients were treated with 1-week triple therapy. Six to 10 weeks after the end of therapy, the patients underwent re-endoscopy and received the same biopsy-based methods. In addition, the 13C-urea breath test was performed. The HpSA test was performed before and 6-10 weeks after the end of therapy. In 23 patients, the HpSA test was also performed at the end of therapy. RESULTS: Before therapy, the sensitivity and specificity of the HpSA test was 98.3% (95% confidence interval (CI): 95.9-100%) and 95.0% (95% CI: 75.1-99.9%), respectively. At the end of therapy, the HpSA tests were all negative both for eradication and non-eradication patients. The sensitivity and specificity of the HpSA test after eradication therapy were 90% (95% CI: 55.5-99.7%) and 97.7% (95% CI: 93.3-100%), respectively. CONCLUSIONS: The HpSA test is a useful method for the diagnosis of H. pylori infection before and after eradication therapy.     

HpSA试验监测幽门螺杆菌感染根除效果的价值

目的检测粪便幽门螺杆菌抗原(HpSA)水平在根除治疗期间及以后的变化,并评估根除治疗疗效检测的最佳时间。方法受试者为57例Hp阳性的病人,均接受了一周的三联疗法。根除治疗的结果由尿素呼气试验、细菌培养以及治疗结束后6周时的组织检查来判定。HpSA的水平则从治疗前到治疗后的12周,先后共检测9次。结果根除治疗获得成功组病人的HpSA在治疗结束后立即转阴并保持阴性。而治疗失败组的病人HpSA也在治疗结束后立即转阴,但在治疗结束后2周时又转为阳性。治疗失败组在根除治疗开始后第4天HpSA试验的平均吸收值显著高于根治成功组。HpSA试验诊断(根除成功与否)的准确率在治疗2周以后增长到>90%。治疗结束后第2、6、8、12周HpSA的诊断准确率与治疗结束后第4周相比无显著差异。结论根除成功组病人的HpSA水平在治疗后的变化情况同失败组显著不同。HpSA的检测对于评估根治疗效是非常有意义的,且评估治疗效果的适当时机是在根除治疗后2周以后。     

Evaluation of the Helicobacter pylori stool antigen test for monitoring eradication therapy

OBJECTIVE: We aimed to clarify the time course of the Helicobacter pylori stool antigen (HpSA) level during and after eradication therapy and to determine the appropriate time of measurement of HpSA to evaluate eradication. METHODS: The subjects were 47 patients who were positive for H. pylori. The patients underwent a 1-wk regimen of triple therapy. The outcome of the eradication therapy was judged by urea breath test, culture, and histology 6 wk after the end of treatment. The HpSA level was serially measured nine times from before therapy until 12 wk after the end of therapy. RESULTS: In the group with successful eradication, HpSA became negative immediately after the end of therapy and the negativity persisted. In contrast, in the noneradication group HpSA became negative immediately after therapy, but became positive again within 2 wk after the end of therapy. The mean absorbance value of the HpSA test on the 4th day after the initiation of eradication therapy was significantly higher in the noneradication group than in the group with successful eradication. The diagnostic accuracy of the HpSA test increased to > or = 90% 2 wk after therapy and thereafter. Comparison of the diagnostic accuracy at 4 wk after the end of therapy showed no significant differences with that at 2, 6, 8, and 12 wk after the end of therapy. CONCLUSIONS: The course of the HpSA levels during and after eradication therapy in patients with successful eradication was quite different from that in noneradication patients. Measurement of HpSA was useful to evaluate eradication, and the appropriate evaluation of the outcome of treatment could be made as early as 2 wk after the end of therapy.     

Usefulness of the Helicobacter pylori stool antigen test for detection Helicobacter pylori infection

Several diagnostic tests are available for evaluating Helicobacter pylori (H. pylori) infection: histological examination, culture of gastric biopsy specimens, rapid urease test, urea breath test and serology. In this study, we assessed the reliability of a newly developed enzyme immunoassay HpSA (H. pylori Stool Antigen) kit for detecting H. pylori antigen in stool. Eighty-five patients (50 males, 35 females; mean age 41.6 +/- 9.8 years) with dyspeptic symptoms who were examined by upper gastrointestinal endoscopy. The patients with a history of previous treatment with proton pump inhibitors, bismuth compounds or antibiotics were excluded. During the endoscopic examination biopsies were taken from antrum and corpus for rapid urease test and histological examination. Stool specimens were submitted to the laboratory and HpSA test was performed. H. pylori was considered in condition with rapid urease test and histopathological examination for H. pylori positive. Forty-six of 85 patients were positive and remaining 39 patients were negative for H. pylori with the rapid urease test and pathologic evaluation. When 0.160 was adopted as the cut-off value, in accordance with the manufacturer's recommendations; stool antigen has been detected in 45 of the 46 H. pylori positive patients. The sensitivity and specificity of HpSA test were 97.8%, 94.9% respectively. These results indicate that HpSA is a highly reliable diagnostic method for H. pylori infection.     

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.     

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.     

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。     

Evaluation of the monoclonal stool antigen test for Helicobacter pylori in an Asian population with dyspepsia

OBJECTIVE: Although well established in the West, stool antigen tests (SAT) are not widely used in Asia. Data on the accuracy of this test in Asia is sparse and, to date, there have been no studies looking at the more refined monoclonal SAT. The aim of this study is to validate the diagnostic accuracy of a stool antigen test, Hp STAR, for the detection of Helicobacter pylori. METHODS: Consecutive new patients with dyspepsia, referred to the endoscopy unit were recruited. At endoscopy, biopsies were taken for rapid urease tests and histology. Stool specimens were collected before any therapy was given and were tested for H. pylori using the monoclonal SAT HpSTAR test. Samples were collected from 90 patients. The stool antigen results were compared with the results of rapid urease tests and histopathology, which were used together as the gold standard test in the diagnosis of H. pylori. RESULTS: Of the 90 patients tested, 45 were H. pylori positive and 45 were H. pylori negative. There was one false positive and one false negative test. The sensitivity, specificity, positive predictive value and negative predictive value for the Hp STAR were identical: 97.8% with a 95% confidence interval of 88.2-99.9%. The diagnostic accuracy was 97.8% with a 95% confidence interval of 92.2-99.7%. CONCLUSION: The monoclonal stool antigen test, HpSTAR is a highly accurate test for the diagnosis of H. pylori.     

幽门螺杆菌粪便抗原检测在体检人群中的应用价值

[目的]探讨中老年人群幽门螺杆菌(HP)感染情况及HP粪便抗原(HPSA)在体检中的应用价值.[方法]对1 774例≥40岁人群粪便标本进行HPSA检测,分析HP感染及其与胃病症状的关系.[结果]1774例中HP阳性者251例,HP阳性率14.15％; 40～～50岁者HP阳性率最高(19.71％),＞80岁者阳性率最低(9.04％);HP感染与吸烟饮酒的生活习惯及胃部症状无关.[结论]生活条件良好的中老年群体HP阳性率呈收敛趋势,与吸烟、饮酒无明显关系,无症状人群应重视HPSA监测,HP阳性人群应行胃镜检查.     

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.     

Gastroduodenal Helicobacter pylori infection diagnosed by Helicobacter pylori stool antigen is related to atherosclerosis

OBJECTIVE: The causative relation between Helicobacter pylori (H. pylori) and atherosclerosis has been determined as seropositivity or determination of H. pylori from atherome plaques by molecular methods. The site of entrance and the reservoir of the bacteria in the body is still a subject of discussion. In this study Helicobacter pylori stool antigen (HpSA) which shows gastrointestinal system colonization and infection with high specificity and sensitivity was determined in atherosclerotic, ectatic and angiographically normal groups. METHODS AND RESULTS: A total of 62 patients was categorized according to diagnostic coronary angiography as 12 had normal coronary arteries, eight had one, 18 had two, and 12 had three atherosclerotic coronary arteries. Twelve patients had ectatic vessels. There were 27 (44%) HpSA positive and 35 (56%) HpSA negative patients. There was a statistically significant relation between HpSA positivity and the degree of vessel involvement in coronary artery disease (CAD) patients, essentially between the group with three vessels (83%) obstructed and the normal group (25%). Ectatic vessel group had a higher incidence (50%) of HpSA positivity compared to the control group but not enough for statistical significance. CONCLUSIONS: The results indicate that gastrointestinal system H. pylori colonization increases the risk of atherosclerosis. We may speculate that the reservoir and spread of H. pylori is via gastrointestinal tract. Studies may be performed to detect whether gastrointestinal tract H. pylori infection treatment will decrease the risk of coronary artery damage caused by H. pylori.     

Helicobacter pylori infection diagnosis in hospitalised elderly patients: the stool antigen test (HpSA) in comparison with other methods

BACKGROUND AND AIMS: Helicobacter pylori (Hp) infection prevalence increases with age. In elderly patients, who often do not collaborate and who are affected by multiple pathologies, worldwide-recognised invasive and non-invasive methods (histology and Urea Breath Test) are not easy to apply. A new test based on the detection of Hp antigens in the stool (HpSA test) is now available. The aim of our study was to evaluate the sensitivity and specificity of the HpSA test, and the interference of drugs (acid suppression, antibiotics) on test performance. METHODS: Hp infection was detected by UBT, HpSA and histology in 122 hospitalised elderly subjects, divided into two groups according to therapy in the last month. Subjects were classified as being Hp-positive if two test results (histology and UBT) were positive, and Hp-negative if the same two test results were negative. RESULTS: The sensitivity and specificity of the HpSA test compared with two tests (histology and UBT) were respectively 76 and 95%. In the group of patients who had not received drugs, the sensitivity and specificity of the HpSA test were respectively 76 and 96%. Instead, in the group of patients who had received pharmacological therapy, sensitivity and specificity values were respectively 67 and 100%. HpSA-positive patients had received acid suppression for 9.2 +/- 8.9 days, and false-negative patients for 27.2 +/- 9.9 days. CONCLUSIONS: The HpSA test is simple, inexpensive, and non-invasive for Hp detection, especially in elderly subjects with no compliance. It is influenced only after several days by therapy common in the elderly.     

受试者工作特征曲线法分析粪便幽门螺杆菌特异性抗原试验的诊断效率

目的 探讨粪便幽门螺杆菌特异性抗原(HpSA)在诊断Hp感染中的价值.方法 因上消化道症状就诊的患者353例,采用酶联免疫吸附法(ELISA)和酶免疫法(EIA)检测HpSA,以~(13)C-尿素呼气试验(~(13)C-UBT)为诊断Hp感染的"金标准".应用不拘分布形式参数法(拟合双正态模型)和非参数法分别绘制光滑受试者工作特征(ROC)曲线和经验ROC曲线,以曲线下面积(Az)评价HpSA试验的诊断价值.结果 ELISA和EIA法检测Hp感染阳性数与~(13)C-UBT检测比较差异无统计学意义(169例和170例比177例,P值均>0.05).ELISA和EIA法检测HpSA符合率98.58%(Kappa值=0.97).ELISA法检测HpSA的不拘分布形式参数法和非参数法Az分别为0.96和0.95,EIA法检测HpSA的不拘分布形式参数法和非参数法Az分别为0.97和0.94,与完全无诊断价值的机会线下面积(0.50)相比差异均有统计学意义(P值均<0.001);两种方法Az相关系数为0.61,面积差异无统计学意义(P>0.05).结论 ROC曲线作为一种统计学工具可以更加客观、真实的评价诊断试验.ELISA和EIA法检测HpSA诊断Hp感染其准确性和可靠性均较高,值得临床进一步推广.