^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。     

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。     

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％。     

四种检测幽门螺杆菌感染方法的评价：病理组织学斌血清学,^13C …

检测幽门螺杆菌的方法很多，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１００     

几种幽门螺杆菌检测方法的比较和评价

目的检测幽门螺杆菌(Helicobacterpylori,Hp)感染的方法很多.本研究对检测Hp的病理组织学、血清学、13C呼气试验(13C-UBT)以及快速尿素酶(HpUT)试验进行比较分析和评价方法151例因各种消化道症状就诊的患者均行内镜检查,同时应用病理组织学,血清学,13C呼气试验(13CUBT)以及快速尿素酶(HpUT)等四种方法检测幽门螺杆菌.其中两项阳性被认为Hp感染存在.结果①151例患者中Hp阳性者127例,总感染率84.1%.②病理组织学、血清学、13C呼气试验、快速尿素酶检测的敏感度分别为88.1%,78.7%,88.2%,71.6%;特异度分别为100%,70.3%,95.0%,63.8%.③四种方法检测的符合率@HpUT与病理组织染色检测的符合率是77.9%.bHpUT与13C-UBT的符合率为70.6%.cHpUT与血清抗体检测的符合率为82%.d病理组织染色与13C-UBT的符合率为74.2%.⑤病理组织染色与血清抗体检测的符合率为63%.⑥13C-UBT与血清抗体检测的符合率为66.7%结论四种检测方法中病理组织染色与13C-UBT的敏感性和特异性都比较高.这两种检查能比较准确地反映体内Hp感染的真实情况.13C-UBT更能准确反映全胃Hp感染的实际情况.快速尿素酶试验和血清抗体检测的结果也较好,其操作方便,费用低,也可作为临床常用的检测手段.两种检查方法的联合为诊断Hp感染较好的选择.以13C呼气试验与HpUT联合;病理组织学W-S染色与HpUT联合的阳性率、敏感度、特异性以及诊断符合率、阳性预测值、阴性预测值同时较高     

13C尿素呼气试验在胃镜检查前后检测幽门螺杆菌的比较

[目的]观察~(13)C尿素呼气试验在胃镜检查前后检测幽门螺杆菌结果的变化。[方法]对胃癌高发区甘肃省武威地区自然筛查人群,采用~(13)C-尿素呼气试验检测胃镜检查前后幽门螺杆菌感染结果。[结果]~(13)C尿素呼气试验在胃镜检查前检测幽门螺杆菌阳性率为54.9%,在胃镜检查后检测幽门螺杆菌阳性率为52.1%,二者间比较差异无统计学意义(P0.05)。[结论]胃镜检查不影响~(13)C尿素呼气试验检测幽门螺杆菌感染的结果,因此医生在开具~(13)C尿素呼气试验检测幽门螺杆菌时可忽略这方面的影响。     

~(13)C-尿素呼气试验、血清胃蛋白酶原在慢性萎缩性胃炎筛查中价值的初探

背景:慢性萎缩性胃炎为胃癌的癌前病变。幽门螺杆菌(Hp)能引起胃黏膜细胞的慢性炎症,促使血液中胃蛋白酶原(PG)含量发生变化,从而反映胃黏膜萎缩状态,为诊断萎缩性胃炎提供依据。~(13)C-尿素呼气试验是一种应用广泛的Hp感染检测方法。目的:探讨~(13)C-尿素呼气试验、血清PG在慢性萎缩性胃炎筛查中的应用价值。方法:选取2016年10月—2017年10月在上海电力医院行胃镜病理检查诊断为慢性胃炎的164例患者,分为慢性萎缩性胃炎组和慢性非萎缩性胃炎组,以病理学结果评估Hp感染情况。比较慢性胃炎Hp阳性和阴性亚组中血清PGⅠ、PGⅡ和PGⅠ/PGⅡ比值(PGR)以及肠化生情况,并评估~(13)C-尿素呼气试验判断Hp感染的准确性。结果:慢性萎缩性胃炎Hp阳性和阴性亚组血清PGⅠ水平和PGR均显著低于慢性非萎缩性胃炎Hp阳性和Hp阴性亚组(P0.05);而PGⅡ水平无明显差异(P0.05)。慢性萎缩性胃炎Hp阳性亚组血清PGⅠ、PGⅡ显著高于Hp阴性亚组(P0.05),PGR显著降低(P0.05),肠化生率显著升高(P0.05)。~(13)C-尿素呼气试验诊断Hp阳性的总体准确率为96.3%,敏感性为96.6%,特异性为96.1%。结论:Hp感染与血清PG含量变化有一定相关性,Hp感染可提高慢性萎缩性胃炎的肠化生率。~(13)C-尿素呼气试验是一种无创、有效的Hp感染检测方法。~(13)C-尿素呼气试验、血清PG检测可为胃癌及其癌前病变的早期诊断和治疗提供有价值的依据。     

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。     

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。     

红外能谱仪检测~(13)C-尿素呼气试验诊断幽门螺杆菌感染

目的：验证红外能谱仪检测１３Ｃ－尿素呼气试验（ＵＢＴ）诊断幽门螺杆菌（Ｈ．ｐｙｌｏｒｉ）感染的可靠性,并与气体质谱仪检测结果作一比较。方法：对７６例患者以红外能谱仪进行１３Ｃ－ＵＢＴ检测Ｈ． ｐｙｌｏｒｉ感染,Ｈ． ｐｙｌｏｒｉ感染状态由快速尿素酶试验、组织学检查以及细菌培养确定。其中１７例患者的呼气样本分别用红外能谱仪与气体质谱仪进行检测。结果：７６例患者中Ｈ． ｐｙｌｏｒｉ阳性者４３例（５６．６％）,红外能谱仪进行１３Ｃ－ＵＢＴ的测定结果为４１例（５３．９％）,其敏感性和特异性分别达到９３．０％和９７．０％。气体质谱仪与红外能谱仪的检测数值相差无几。结论：以红外能谱仪进行１３Ｃ－ＵＢＴ检测可靠、准确地诊断Ｈ．ｐｙｌｏｒｉ感染,并具有简单、实用的特点。红外能谱仪与气体质谱仪一样可被广泛应用于Ｈ．ｐｙｌｏｒｉ检测。     

Validation of the 13c-urea breath test for the initial diagnosis of helicobacter pylori infection and to confirm eradication after treatment.

OBJECTIVES: the breath test with 13C-urea (UBT) is a method widely used in Spain, but its diagnostic accuracy has not been evaluated in a clinical trial until now. Our objective was to validate the UBT (TAU-KIT) both as an initial diagnostic method for the detection of H. pylori infection and as a method to confirm eradication. METHODS: a multi-centre study in 7 Spanish hospitals was performed. A group of dyspeptic patients who had not previously received eradication treatment was included, and a second group of patients with gastric ulcer or upper gastrointestinal bleeding due to peptic ulcer was also included (eradication of H. pylori was confirmed 6 to 8 weeks after treatment completion with omeprazole, clarithromycin and amoxycillin). In both groups an endoscopy was performed with biopsies for histology and rapid urease test. Patients were considered infected if both tests yielded positive results, and not infected when both tests were negative. The UBT 13C-urea (TAU-KIT, Isomed S.L., Madrid, Spain) was performed with citric acid and 100 mg of 13C-urea. The pathologist and persons responsible for endoscopy, urease test and UBT were all unaware of the results from the other diagnostic methods. RESULTS: in the pre-treatment group (36 patients) the prevalence of H. pylori was 72%, the area under the ROC curve for the diagnosis of infection with the UBT was 0.99, and the best cut-off point was 5 units, with the following results: sensitivity= 96% (95% CI = 81-99%), specificity= 100% (69-100%), positive predictive value (PPV) = 100% (87-100%), negative predictive value (NPV) = 92% (59-100%), likelihood ratio (LR) + = infinity, and LR- = 0.04. In the post-treatment group (85 patients) the prevalence of H. pylori was 16%, the area under the ROC curve was 0.99, and the best cut point was 4.6, with the following results: sensitivity= 100% (77-100%), specificity = 97% (90-99%), PPV = 88% (62-98%), NPV = 100% (95-100%), LR+ = 35, and LR- = 0. CONCLUSION: UBT provides excellent accuracy both for the initial diagnosis of H. pylori infection and to confirm eradication after treatment.     

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.     

Enzyme-linked immunosorbent assay for serodiagnosis of Helicobacter pylori in dyspeptic patients and volunteer blood donors

Helicobacter pylori, an important etiological agent in the development of gastritis, peptic ulcer and gastric carcinoma, can be detected by the enzyme-linked immunosorbent assay (ELISA). Our objectives were: (1) to evaluate the efficacy of a commercial ELISA kit (Pyloriset EIA-G III) in sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy for diagnosis of H. pylori infection in Thai dyspeptic patients in Khon Kaen Thailand; and (2) to examine the seroprevalence of H. pylori among blood donors at Srinagarind Hospital's Blood Bank, Khon Kaen University, by the commercial ELISA. Gastric biopsies obtained from 137 dyspeptic patients were diagnosed by culture, rapid urease test (RUT) and histology. Serum samples from the same dyspeptic patients and 100 healthy blood donors were assayed using the commercial ELISA. H. pylori infection in dyspeptic patients was considered positive when the culture or both RUT and histology were positive. Using a cut-off value at a titer of 20 U/ml (as recommended by the manufacturer), we found the commercial ELISA kit had a sensitivity of 93.3%, specificity of 75.3%, PPV of 74.7%, NPV of 93.5% and accuracy of 83.2%. The overall H. pylori seroprevalence in the healthy blood donors was 57%. Of the 100 healthy blood donors, 39 (60.9%) of the males and 18 (50.0%) of the females were seropositive.     

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.