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。     

^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。     

残胃对^14C-尿素呼气试验影响的研究

目的：评估用^14C-尿素呼气试验(^14C-UBT)检测残胃幽门螺杆菌(HP)感染的准确性．方法；残胃32例及对照组40例病人先用金标准(胃镜检查时于胃窦和胃体各取两块粘膜活组织，作快逮尿素酶试验和常规病理切片5张，Giemsa染色镜检HP)定性．再用^14C-UBT检刊HP．用X^2检验两组结果的准确性．结果一用全标准检测的残胃和对用组的阴性病人(分别为20例和14例)再用^14C-UBT检测未出现假阳性，而残胃组的12例和对照组的26例阳性病人用^14C-UBT检测各出现一例假胡性。两种方法检测的准确性无显性差别，X^2=0.315．P>O．5。结论，残胃对用^14C-UBT检HP的准确性无影响。     

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。     

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。     

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。     

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。     

微量胶囊^14C-尿素呼气诊断胃内幽门螺杆菌的临床价值

胃内幽门螺杆菌(简称Hp)感染与消化疾病密切相关,故诊断Hp感染显得尤为重要。目前诊断Kp的方法很,多为侵人性(包括快速尿素酶、病理染色、细菌培养等),对患具有一定创伤和痛苦;血清Hp-IgG抗体测定为非侵人性,但根除Hp后血清Hp抗体需长时间才能转阴,不宜疗效考核。无创伤性呼气试验可作为根除Hp前后诊断的金标准。我院于1998年5月至1999年5月,采用微量^14C-尿素呼气法(简称^14C-UBT)诊断Hp感染,同时予快速尿素酶法(RUT)、病理染色(W-S染色)对照,及追踪根除Hp后疗效检测。旨在观察^14C-UBT法在诊断胃内Hp感染的临床价值。现报告如下。     

微剂量^14HC-尿素呼气试验诊断幽门螺杆菌感染

本研究旨在评价微剂量(37kBq)^14C-尿素呼气试验(^14C-UBT)对幽仃螺扦菌(Hn感染的诊断教果。106例病人清晨空腹饮下37kBq^14C-尿素水溶液，海胺溶液吸收20分钟呼气CO2；2mm01．液闪仪测定^14C放射性活性．结果以dpm／mmolCO：表达。19例志愿第二日重复试验。以Warthin-Starry组织染色和快速尿素酶试验作为参照标准，ROC分析法确定^14C-UBT最适判别值。结果得出^14C-UBT最适判别值为250dpm／mmol CO2；实验对HP感染诊断的敏感性、特异性和准确性分别为98.3%(58／50)、98．7%(46/47)、和98．7%(104／106)；实验重复性良好；体重校正对诊断效果无影响。研究结果提示散剂量^14C-UBT诊断HP感染具有高度的准确性，且简单和安全；试验无需试餐和加用非标记尿素，结果不需以体重校正。     

The clinical utility of string-PCR test in diagnosing Helicobacter pylori infection

BACKGROUND/AIMS: Non-invasive string test has been reported as being convenient and capable of yielding bacteria by means of gastric juice sampling in the diagnosis of Helicobacter pylori infection. Molecular methods, such as polymerase chain reaction for the amplification of DNA, are desirable for the detection of minute quantities of H. pylori. We planned to evaluate the diagnostic efficiency of the combination of the string test and polymerase chain reaction and determine whether the string polymerase chain reaction test could obtain more information in conditions where the bacterial load is so low that other diagnostic tests fail to confirm the presence of H. pylori. METHODOLOGY: We enrolled 48 dyspeptic patients, including 29 males and 19 females, with a mean age of 52.5 years. Each patient received endoscopy and biopsy-based tests, including RUT (rapid urease test), cultures, and histology, followed by 13C-UBT (13Carbon urea breath test). We used the string test, (Entero-Test H. pylori, HDC Corporation, CA, US), for gastric juice sampling. The specimen was further analyzed by polymerase chain reaction for the presence of H. pylori with the primer for cagA gene, which is highly prevalent in Taiwan. H. pylori infection was considered as positive when either culture yield was positive, or when two of the other three tests, including RUT, histology, and 13C-UBT, were positive. RESULTS: Of the total 48 patients, 34 patients were H. pylori-positive, and 14 were H. pylori-negative. A fragment of 349 bp of polymerase chain reaction products was detected by agarose gel electrophoresis in 32 out of 34 patients who was classified as H. pylori-positive. The sensitivity, specificity, positive predictive value, and negative predictive value of the string polymerase chain reaction test were 94.12%, 96.97%, 92.86%, and 86.67%, respectively. These results are comparable to 13C-UBT and RUT, and better than histology and culture. One subject, who tested as H. pylori-negative according to the diagnostic criteria, had positive 13C-UBT and string polymerase chain reaction test results. Further sequencing of the DNA obtained from the results of polymerase chain reaction product was performed and it showed 98% identities with the known sequence of cagA strain H. pylori (GenBank accession number: AF249275). CONCLUSIONS: The string polymerase chain reaction test is non-invasive and provides direct bacterial yields. Its diagnostic efficiency is comparable with 13C-UBT and RUT in detecting H. pylori infection. Also, with the assistance of polymerase chain reaction and DNA sequencing, we can diagnose H. pylori infection even when the bacterial load is low. Further application of string polymerase chain reaction test in the genetic analysis of virulent and resistant strains seems promising.     

Evaluation of urine ELISA test for detecting Helicobacter pylori infection in Taiwan： A prospective study

AIM: To evaluate the diagnostic accuracy and clinical utility of a new ELISA (URINELISA) test for detecting Helicobacter pylori(H pylori) antibody in the urine of Taiwanese population. METHODS: In this prospective study, 317 consecutive dyspeptic patients (171 men, 146 women; mean age, 51.0 years) were included. They underwent gastroendoscopy for evaluation. Invasive tests, including culture, histology, and rapid urease test (RUT), and non-invasive ~(13)C-urea breath test were preformed. At the same time, urine specimens were collected for URINELISA. The status of H pylori infection was considered as positive when either culture was positive, or when two of the other, RUT, histology or 13C-UBT, were positive. RESULTS: The sensitivity, specificity, positive predictive value, and negative predictive value of URINELISA are 91.7% (211/230), 90.8% (79/87), 96.3% (211/219), and 80.6% (79/98) respectively. CONCLUSION: This URINELISA test is reliable, inexpensive and easy-to-use. The high diagnostic accuracy warrants the use of URINELISA as a first-line screening tool for diagnosis of H pylori infection in untreated patients.     

~(13)C-尿素呼气试验诊断幽门螺杆菌感染的研究

本研究旨在评估~(13)C,尿素呼气试验检测幽门螺杆菌感染的可靠性。方法:我们在82例因胃病而行胃镜检查的患者胃窦和胃体取多个活检标本,作组织学、牯膜涂片和快速尿素酶试验,以决定是否感染幽门螺杆菌,并作~(13)C-尿素呼气试验。~(13)C-尿素呼气试验的敏感性、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幽门螺杆菌的结果比较而计算得到。结果:~(13)C-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:~(13)C-尿素呼气试验有高度敏感性和特异性,对确定患者的幽门螺杆菌感染状态是一可靠的无创伤的诊断方法。     

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。     

四种检测幽门螺杆菌感染方法的评价──病理组织学、血清学、~(13)C呼气试验和快速尿素酶试验

目的检测幽门螺杆菌（HelicobacterpyloriHp）的方法很多，本文对病理组织学，血清学，快速尿素酶和13C呼气试验进行分析评价．方法对70例有消化道症状的患者进行以上四种方法检测幽门螺杆菌，其中二项阳性者认为有Hp感染。结果病理组织学，血清学，13C呼气试验，快速尿素酶检测的敏感性分别为83．33％，90．74％，96．30％，85．52％；特异性分别为100％，100％，81．25％，75％。四种方法的阳性预测值分别为11％，100％，94．55％，92％；阴性预测值分别为64％，76．19％，86.67％，60％。结论病理组织学与呼气试验是检测Hp感染的较准确的测定方法，呼气试验更能反映“全胃”Hp感染状况，目前可作为抗Hp药物疗效监测的“金标准”。血清学检测和快速尿素酶法操作方便，费用低，是临床常用的检测手段。     

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。     

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.     

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％。     

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。     

Noninvasive tests as a substitute for histology in the diagnosis of Helicobacter pylori infection

BACKGROUND: Rapid urease tests for Helicobacter pylori have a sensitivity of 80% to 90%. Therefore histologic examination of gastric biopsies is recommended as a "backup" diagnostic test in rapid urease test-negative patients. However, noninvasive tests (urea breath test, serology, whole blood antibody tests) may provide a more rapid diagnosis and be less expensive but offer similar accuracy. METHODS: Sixty-seven patients (no prior treatment for H pylori, no proton pump inhibitors, antibiotics, or bismuth within 4 weeks) undergoing endoscopy for evaluation of dyspepsia symptoms and testing rapid urease test-negative by antral biopsy were enrolled. All had the following tests: gastric biopsies (2 antral, 1 fundus; H&E and Alcian Yellow stain) examined for gastritis and H pylori; (13)C-UBT; capillary blood for whole blood rapid antibody tests: FlexSure HP, QuickVue, AccuStat, and Stat-Simple Pylori; serum for FlexSure HP; HM-CAP enzyme-linked immunoassay. H pylori infection was diagnosed (reference standard) if chronic gastritis was present on histology and at least 2 of the 3 following tests were positive: urea breath test, H pylori organisms unequivocally demonstrated in biopsies on special stain, and/or enzyme-linked immunoassay. The test and treatment costs per patient were calculated. RESULTS: Of 67 patients with a negative rapid urease test, 4 were positive for H pylori. None had active peptic ulcer disease. Histology only identified 1 patient with organisms visible on special stain. Using chronic active gastritis (neutrophilic and mononuclear infiltrate) as a diagnostic criterion for H pylori, 6 patients would have been judged positive. However, only 2 of these were truly positive by the reference standard (positive predictive value 33%). Negative predictive value for presence of organisms and chronic active gastritis was 95% and 97%, respectively. All of the noninvasive tests identified all 4 truly positive patients correctly. Urea breath test and FlexSure whole blood assay yielded a substantial number of false-positive results (positive predictive value 31% and 36%, respectively); positive predictive value for the other tests ranged from 50% to 80%. All tests except histology had a negative predictive value of 100%. Histology was the most costly test (p < 0. 001 compared with all other tests), followed by urea breath test and HM-CAP serology (p < 0.001 compared with all rapid antibody tests). CONCLUSIONS: Whole blood or serum antibody testing is a rapid, accurate, and cost-effective means for establishing H pylori status in rapid urease test-negative patients. Whole blood or serology rapid antibody testing should substitute for histology when the patient has not been previously treated for H pylori.