|
1
|
Nishizuka SS, Nakatochi M, Koizumi Y, Hishida A, Okada R, Kawai S, Sutoh Y, Koeda K, Shimizu A, Naito M, Wakai K. Anti-Helicobacter pylori antibody status is associated with cancer mortality: A longitudinal analysis from the Japanese DAIKO prospective cohort study. PLOS GLOBAL PUBLIC HEALTH 2023; 3:e0001125. [PMID: 36962964 PMCID: PMC10022139 DOI: 10.1371/journal.pgph.0001125] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/01/2022] [Accepted: 12/22/2022] [Indexed: 02/10/2023]
Abstract
Paradoxically, patients with advanced stomach cancer who are Helicobacter pylori-positive (HP+) have a higher survival rate than those who are HP-. This finding suggests that HP infection has beneficial effects for cancer treatment. The present study examines whether HP+ individuals have a lower likelihood of death from cancer than those who are HP-. Prospective cohort data (n = 4,982 subjects enrolled in the DAIKO study between 2008-2010) were used to assess whether anti-HP antibody status was associated with cancer incidence. The median age in the primary registry was 53 years-old (range 35-69 years-old). Over the 8-year observation period there were 234 (4.7%) cancer cases in the cohort and 88 (1.8%) all-cause deaths. Urine anti-HP antibody data was available for all but one participant (n = 4,981; 99.98%). The number of HP+ and HP- individuals was 1,825 (37%) and 3,156 (63%), respectively. Anti-HP antibody distribution per birth year revealed that earlier birth year was associated with higher HP+ rates. With a birth year-matched cohort (n = 3,376), all-cancer incidence was significantly higher in HP+ individuals than those who were HP- (p = 0.00328), whereas there was no significant difference in the cancer death rate between HP+ and HP- individuals (p = 0.888). Cox regression analysis for prognostic factors revealed that the hazards ratio of HP+ was 1.59-fold (95%CI 1.17-2.26) higher than HP- in all-cancer incidence. Potential systemic effects of HP+ status may contribute to reduced likelihood of death for patients after an initial diagnosis of cancer.
Collapse
Affiliation(s)
- Satoshi S Nishizuka
- Division of Biomedical Research & Development, Iwate Medical University Institute for Biomedical Sciences, Yahaba, Japan
| | - Masahiro Nakatochi
- Department of Integrated Health Sciences, Public Health Informatics Unit, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Yuka Koizumi
- Division of Biomedical Research & Development, Iwate Medical University Institute for Biomedical Sciences, Yahaba, Japan
| | - Asahi Hishida
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Rieko Okada
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Sayo Kawai
- Department of Public Health, Aichi Medical University School of Medicine, Nagakute, Aichi, Japan
| | - Yoichi Sutoh
- Division of Biomedical Information Analysis, Iwate Tohoku Medical Megabank Organization, Iwate Medical University, Yahaba, Japan
| | - Keisuke Koeda
- Department of Medical Safety Science, Iwate Medical University School of Medicine, Yahaba, Japan
| | - Atsushi Shimizu
- Division of Biomedical Information Analysis, Iwate Tohoku Medical Megabank Organization, Iwate Medical University, Yahaba, Japan
- Division of Biomedical Information Analysis, Iwate Medical University Institute for Biomedical Sciences, Yahaba, Japan
| | - Mariko Naito
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan
- Department of Oral Epidemiology, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan
| | - Kenji Wakai
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan
| |
Collapse
|
|
2
|
Chattopadhyay S, Choudhary M, Singh H. Carbon dots and graphene oxide based FRET immunosensor for sensitive detection of Helicobacter pylori. Anal Biochem 2022; 654:114801. [DOI: 10.1016/j.ab.2022.114801] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/19/2022] [Revised: 06/15/2022] [Accepted: 06/28/2022] [Indexed: 02/06/2023]
|
|
3
|
Aumpan N, Vilaichone RK, Chotivitayatarakorn P, Pornthisarn B, Cholprasertsuk S, Bhanthumkomol P, Kanokwanvimol A, Siramolpiwat S, Mahachai V. High Efficacy of Rapid Urine Test for Diagnosis of Helicobacter pylori Infection in Thai People. Asian Pac J Cancer Prev 2019; 20:1525-1529. [PMID: 31128058 PMCID: PMC6857864 DOI: 10.31557/apjcp.2019.20.5.1525] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/04/2023] Open
Abstract
Background: Accurate diagnosis of Helicobacter pylori (H. pylori) infection plays an important role in further effective treatment. Rapid urine test (RAPIRUN) is a test developed for qualitative detection of urine H. Pylori antibody and use for determine the sensitivity, specificity and accuracy. However, the test needs validation in Thai population before using in clinical practice. Objective: This study aimed to compare performance of different diagnostic tests on H. pylori detection in Thai population. Methods: Total of 94 patients with dyspepsia who referred to Thammasat University Hospital, Pathumthani, Thailand, between December 2012 and April 2013 were enrolled in this study. All patients underwent gastroscopy. Then, 3 biopsies at antrum were taken for H. pylori diagnosis. including rapid urease test (Pronto Dry, Eisai, Thailand), H. pylori culture, and histopathology. Urine samples were also collected at the same time for rapid urine test (RAPIRUN H. pylori Antibody, Otsuka Pharmaceutical Co., Ltd.). Patients were diagnosed with H. pylori-positive if their culture or rapid urease tests plus histopathology yielded positive results. Results: Total of 29 patients (30.9%) were infected with H. pylori. Prevalence of H. pylori infection by rapid urease test, histopathology, culture and rapid urine test were 25.5%, 28.7%, 29.8%, and 32.9% respectively. We observed that rapid urease test, histopathology, culture, and rapid urine test had sensitivity of 82.8%, 93.1%, 93.1% and 86.2%; specificity of 100%, 100%, 100%, and 90.8%; and accuracy of 95.7%, 97.9%, 97.9%, and 89.4%, respectively. Conclusion: Rapid urine test (RAPIRUN) provided a reliable result for diagnosis of H. pylori infection. Furthermore, this rapid urine test demonstrated high accuracy, reliable, safe handle and easy to use. We suggested rapid urine test for diagnosis of H. pylori infection in Thai population since we found it less invasive and with higher reliable efficacy.
Collapse
Affiliation(s)
- Natsuda Aumpan
- Gastroenterology Unit, Department of Medicine, Faculty of Medicine, Thammasat University Hospital, Pathumthani, Thailand.
| | - Ratha-Korn Vilaichone
- Gastroenterology Unit, Department of Medicine, Faculty of Medicine, Thammasat University Hospital, Pathumthani, Thailand. ,Digestive Diseases Research Center of Thailand, Pathumthani, Thailand.,Department of Medicine, Chulabhorn International College of Medicine (CICM) at Thammasat University, Pathumthani, Thailand
| | - Peranart Chotivitayatarakorn
- Gastroenterology Unit, Department of Medicine, Faculty of Medicine, Thammasat University Hospital, Pathumthani, Thailand. ,Digestive Diseases Research Center of Thailand, Pathumthani, Thailand.,Department of Medicine, Chulabhorn International College of Medicine (CICM) at Thammasat University, Pathumthani, Thailand
| | - Bubpha Pornthisarn
- Gastroenterology Unit, Department of Medicine, Faculty of Medicine, Thammasat University Hospital, Pathumthani, Thailand.
| | - Soonthorn Cholprasertsuk
- Gastroenterology Unit, Department of Medicine, Faculty of Medicine, Thammasat University Hospital, Pathumthani, Thailand.
| | - Patommatat Bhanthumkomol
- Gastroenterology Unit, Department of Medicine, Faculty of Medicine, Thammasat University Hospital, Pathumthani, Thailand.
| | - Amornnivit Kanokwanvimol
- Gastroenterology Unit, Department of Medicine, Faculty of Medicine, Thammasat University Hospital, Pathumthani, Thailand.
| | - Sith Siramolpiwat
- Gastroenterology Unit, Department of Medicine, Faculty of Medicine, Thammasat University Hospital, Pathumthani, Thailand. ,Department of Medicine, Chulabhorn International College of Medicine (CICM) at Thammasat University, Pathumthani, Thailand
| | - Varocha Mahachai
- Digestive Diseases Research Center of Thailand, Pathumthani, Thailand.,Department of Medicine, Chulabhorn International College of Medicine (CICM) at Thammasat University, Pathumthani, Thailand.,Gastrointestinal and Liver Center, Bangkok Medical Center, Bangkok, Thailand
| |
Collapse
|
|
4
|
Mohammadian T, Ganji L. The Diagnostic Tests for Detection of Helicobacter pylori Infection. Monoclon Antib Immunodiagn Immunother 2019; 38:1-7. [PMID: 30648911 DOI: 10.1089/mab.2018.0032] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022] Open
Abstract
Helicobacter pylori causes one of the most common infections in human populations. The role of this bacterium in chronic gastritis, gastric ulcer, gastric cancer, as well as extra-digestive diseases such as ischemic heart disease and chronic obstructive pulmonary diseases, is well known. Prevention and control of these diseases can occur by early diagnosis and eradication of H. pylori infection. At present, different methods have been established to detect H. pylori infection. The biopsy-based tests, which are known as invasive methods, such as rapid urease test and histology, have the highest specificity among the others. Similarly, culture of biopsy samples is used for diagnosis of H. pylori infection. It has a high specificity value, and also allows us to perform antibiotic sensitivity testing. On the contrary, polymerase chain reaction and other molecular methods have good sensitivity and specificity, and can be used for detection of H. pylori infection, its virulence factors, and eradication success after treatment. While serological tests are more appropriate for epidemiological studies, their main weakness for clinical use is low specificity. Overall, specificity and sensitivity, cost, usefulness, and limitation of tests should be considered for selection of detection methods of H. pylori in each country.
Collapse
Affiliation(s)
- Taher Mohammadian
- 1 Department of Microbiology, Shahr-e-Qods-Branch, Islamic Azad University, Tehran, Iran
| | - Leila Ganji
- 1 Department of Microbiology, Shahr-e-Qods-Branch, Islamic Azad University, Tehran, Iran.,2 Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Science, Tehran, Iran
| |
Collapse
|
|
5
|
Cisarò F, Pizzol A, Pinon M, Calvo PL. Diagnosis and treatment of Helicobacter pylori in the pediatric population. Minerva Pediatr 2018; 70:476-487. [PMID: 30021412 DOI: 10.23736/s0026-4946.18.05346-x] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
Although about 35 years have elapsed since the discovery of the Helicobacter pylori, its diagnosis and the choice of optimal eradication therapy are still to be defined. Over time, there has been an increase in interest, publications, recommendations and guidelines. Moreover, management of the disease in pediatric subjects differs somewhat to that of adults and requires a more delicate approach leading to alternative strategies for both diagnosis and treatment. Which patient should be investigated for H. pylori, when to perform noninvasive or invasive tests, what are the proper therapeutic options and best antibiotics regimen to eradicate the infection are practices changing with evidences through time. Therefore, an updated guideline was published by the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) in 2017. The aim of this review is to highlight what is new and what differs between adult and pediatric population regarding the management of H. pylori infection after the ESPGHAN/NASPGHAN guidelines, enriched with updates from literature reviews published over the last two years.
Collapse
Affiliation(s)
- Fabio Cisarò
- Unit of Pediatric Gastroenterology, Department of Pediatrics, Città della Salute e della Scienza di Torino, University of Turin, Turin, Italy
| | - Antonio Pizzol
- Unit of Pediatric Gastroenterology, Department of Pediatrics, Città della Salute e della Scienza di Torino, University of Turin, Turin, Italy -
| | - Michele Pinon
- Unit of Pediatric Gastroenterology, Department of Pediatrics, Città della Salute e della Scienza di Torino, University of Turin, Turin, Italy
| | - Pier Luigi Calvo
- Unit of Pediatric Gastroenterology, Department of Pediatrics, Città della Salute e della Scienza di Torino, University of Turin, Turin, Italy
| |
Collapse
|
|
6
|
Randomized controlled trial: PPI-based triple therapy containing metronidazole versus clarithromycin as first-line treatment for Helicobacter pylori in adolescents and young adults in Japan. J Infect Chemother 2018; 24:538-543. [DOI: 10.1016/j.jiac.2018.02.013] [Citation(s) in RCA: 22] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/23/2017] [Revised: 02/07/2018] [Accepted: 02/28/2018] [Indexed: 02/06/2023]
|
|
7
|
Best LMJ, Takwoingi Y, Siddique S, Selladurai A, Gandhi A, Low B, Yaghoobi M, Gurusamy KS, Cochrane Upper GI and Pancreatic Diseases Group. Non-invasive diagnostic tests for Helicobacter pylori infection. Cochrane Database Syst Rev 2018; 3:CD012080. [PMID: 29543326 PMCID: PMC6513531 DOI: 10.1002/14651858.cd012080.pub2] [Citation(s) in RCA: 90] [Impact Index Per Article: 12.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/30/2023]
Abstract
BACKGROUND Helicobacter pylori (H pylori) infection has been implicated in a number of malignancies and non-malignant conditions including peptic ulcers, non-ulcer dyspepsia, recurrent peptic ulcer bleeding, unexplained iron deficiency anaemia, idiopathic thrombocytopaenia purpura, and colorectal adenomas. The confirmatory diagnosis of H pylori is by endoscopic biopsy, followed by histopathological examination using haemotoxylin and eosin (H & E) stain or special stains such as Giemsa stain and Warthin-Starry stain. Special stains are more accurate than H & E stain. There is significant uncertainty about the diagnostic accuracy of non-invasive tests for diagnosis of H pylori. OBJECTIVES To compare the diagnostic accuracy of urea breath test, serology, and stool antigen test, used alone or in combination, for diagnosis of H pylori infection in symptomatic and asymptomatic people, so that eradication therapy for H pylori can be started. SEARCH METHODS We searched MEDLINE, Embase, the Science Citation Index and the National Institute for Health Research Health Technology Assessment Database on 4 March 2016. We screened references in the included studies to identify additional studies. We also conducted citation searches of relevant studies, most recently on 4 December 2016. We did not restrict studies by language or publication status, or whether data were collected prospectively or retrospectively. SELECTION CRITERIA We included diagnostic accuracy studies that evaluated at least one of the index tests (urea breath test using isotopes such as 13C or 14C, serology and stool antigen test) against the reference standard (histopathological examination using H & E stain, special stains or immunohistochemical stain) in people suspected of having H pylori infection. DATA COLLECTION AND ANALYSIS Two review authors independently screened the references to identify relevant studies and independently extracted data. We assessed the methodological quality of studies using the QUADAS-2 tool. We performed meta-analysis by using the hierarchical summary receiver operating characteristic (HSROC) model to estimate and compare SROC curves. Where appropriate, we used bivariate or univariate logistic regression models to estimate summary sensitivities and specificities. MAIN RESULTS We included 101 studies involving 11,003 participants, of which 5839 participants (53.1%) had H pylori infection. The prevalence of H pylori infection in the studies ranged from 15.2% to 94.7%, with a median prevalence of 53.7% (interquartile range 42.0% to 66.5%). Most of the studies (57%) included participants with dyspepsia and 53 studies excluded participants who recently had proton pump inhibitors or antibiotics.There was at least an unclear risk of bias or unclear applicability concern for each study.Of the 101 studies, 15 compared the accuracy of two index tests and two studies compared the accuracy of three index tests. Thirty-four studies (4242 participants) evaluated serology; 29 studies (2988 participants) evaluated stool antigen test; 34 studies (3139 participants) evaluated urea breath test-13C; 21 studies (1810 participants) evaluated urea breath test-14C; and two studies (127 participants) evaluated urea breath test but did not report the isotope used. The thresholds used to define test positivity and the staining techniques used for histopathological examination (reference standard) varied between studies. Due to sparse data for each threshold reported, it was not possible to identify the best threshold for each test.Using data from 99 studies in an indirect test comparison, there was statistical evidence of a difference in diagnostic accuracy between urea breath test-13C, urea breath test-14C, serology and stool antigen test (P = 0.024). The diagnostic odds ratios for urea breath test-13C, urea breath test-14C, serology, and stool antigen test were 153 (95% confidence interval (CI) 73.7 to 316), 105 (95% CI 74.0 to 150), 47.4 (95% CI 25.5 to 88.1) and 45.1 (95% CI 24.2 to 84.1). The sensitivity (95% CI) estimated at a fixed specificity of 0.90 (median from studies across the four tests), was 0.94 (95% CI 0.89 to 0.97) for urea breath test-13C, 0.92 (95% CI 0.89 to 0.94) for urea breath test-14C, 0.84 (95% CI 0.74 to 0.91) for serology, and 0.83 (95% CI 0.73 to 0.90) for stool antigen test. This implies that on average, given a specificity of 0.90 and prevalence of 53.7% (median specificity and prevalence in the studies), out of 1000 people tested for H pylori infection, there will be 46 false positives (people without H pylori infection who will be diagnosed as having H pylori infection). In this hypothetical cohort, urea breath test-13C, urea breath test-14C, serology, and stool antigen test will give 30 (95% CI 15 to 58), 42 (95% CI 30 to 58), 86 (95% CI 50 to 140), and 89 (95% CI 52 to 146) false negatives respectively (people with H pylori infection for whom the diagnosis of H pylori will be missed).Direct comparisons were based on few head-to-head studies. The ratios of diagnostic odds ratios (DORs) were 0.68 (95% CI 0.12 to 3.70; P = 0.56) for urea breath test-13C versus serology (seven studies), and 0.88 (95% CI 0.14 to 5.56; P = 0.84) for urea breath test-13C versus stool antigen test (seven studies). The 95% CIs of these estimates overlap with those of the ratios of DORs from the indirect comparison. Data were limited or unavailable for meta-analysis of other direct comparisons. AUTHORS' CONCLUSIONS In people without a history of gastrectomy and those who have not recently had antibiotics or proton ,pump inhibitors, urea breath tests had high diagnostic accuracy while serology and stool antigen tests were less accurate for diagnosis of Helicobacter pylori infection.This is based on an indirect test comparison (with potential for bias due to confounding), as evidence from direct comparisons was limited or unavailable. The thresholds used for these tests were highly variable and we were unable to identify specific thresholds that might be useful in clinical practice.We need further comparative studies of high methodological quality to obtain more reliable evidence of relative accuracy between the tests. Such studies should be conducted prospectively in a representative spectrum of participants and clearly reported to ensure low risk of bias. Most importantly, studies should prespecify and clearly report thresholds used, and should avoid inappropriate exclusions.
Collapse
Affiliation(s)
- Lawrence MJ Best
- Royal Free Campus, UCL Medical SchoolDepartment of SurgeryRowland Hill StreetLondonUKNW32PF
| | - Yemisi Takwoingi
- University of BirminghamInstitute of Applied Health ResearchEdgbastonBirminghamUKB15 2TT
| | | | | | | | | | - Mohammad Yaghoobi
- McMaster University and McMaster University Health Sciences CentreDivision of Gastroenterology1200 Main Street WestHamiltonONCanada
| | | | | |
Collapse
|
|
8
|
Gong Y, Li Q, Yuan Y. Accuracy of testing for anti- Helicobacter pylori IgG in urine for H. pylori infection diagnosis: a systematic review and meta-analysis. BMJ Open 2017; 7:e013248. [PMID: 28455424 PMCID: PMC5719657 DOI: 10.1136/bmjopen-2016-013248] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022] Open
Abstract
OBJECTIVES This meta-analysis aims to systematically measure the potential diagnostic value of anti-Helicobacter pylori IgG in urine for infection diagnosis, using all eligible studies published in English and Chinese languages. DESIGN The random effect model was used to analyse the pooled sensitivity, specificity, positive likelihood ratio (PLR), negative LR (NLR), diagnostic OR (DOR), together with the summary receiver operator characteristic curve. SETTING Literature searches of databases including PubMed, EMBASE, MEDLINE, Web of Science, Chinese National Knowledge Infrastructure and Wanfang databases were performed to retrieve studies evaluating the diagnostic value of urine IgG antibody for H.pylori infection. PRIMARY OUTCOME MEASURE Twenty-three studies with 4963 subjects were included in the current meta-analysis. RESULTS The pooled sensitivity, specificity, PLR, NLR, DOR and area under the curve (AUC) were 0.83 (95% CI 0.82 to 0.85), 0.89 (95% CI 0.88 to 0.90), 8.81 (95% CI 6.37 to 12.2), 0.13 (95% CI 0.09 to 0.2), 73 (95% CI 46.45 to 114.74) and 0.9551, respectively. Subgroup analyses showed that diagnostic accuracy of the urine IgG assay was no different in age, region, study population and assay method. CONCLUSIONS Anti-H. pylori antibody in urine might serve as a good marker in diagnosing H. pylori infection. However, further validation based on a larger sample is still required.
Collapse
Affiliation(s)
- Yuehua Gong
- Department of Tumor Etiology and Screening, Cancer Institute and General Surgery, The First Affiliated Hospital of China Medical University and Key Laboratory of Cancer Etiology and Prevention, Liaoning Provincial Education Department, Shenyang, China
| | - Qiuping Li
- Department of Tumor Etiology and Screening, Cancer Institute and General Surgery, The First Affiliated Hospital of China Medical University and Key Laboratory of Cancer Etiology and Prevention, Liaoning Provincial Education Department, Shenyang, China
| | - Yuan Yuan
- Department of Tumor Etiology and Screening, Cancer Institute and General Surgery, The First Affiliated Hospital of China Medical University and Key Laboratory of Cancer Etiology and Prevention, Liaoning Provincial Education Department, Shenyang, China
| |
Collapse
|
|
9
|
Cost-Effectiveness Analysis of Helicobacter pylori Diagnostic Methods in Patients with Atrophic Gastritis. Gastroenterol Res Pract 2017; 2017:2453254. [PMID: 28337217 PMCID: PMC5346403 DOI: 10.1155/2017/2453254] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/10/2016] [Revised: 01/06/2017] [Accepted: 01/11/2017] [Indexed: 02/07/2023] Open
Abstract
Background. There are several diagnostic methods for Helicobacter pylori (H. pylori) infection. A cost-effective analysis is needed to decide on the optimal diagnostic method. The aim of this study was to determine a cost-effective diagnostic method in patients with atrophic gastritis (AG). Methods. A decision-analysis model including seven diagnostic methods was constructed for patients with AG diagnosed by esophagogastroduodenoscopy. Expected values of cost and effectiveness were calculated for each test. Results. If the prevalence of H. pylori in the patients with AG is 85% and CAM-resistant H. pylori is 30%, histology, stool H. pylori antigen (SHPAg), bacterial culture (BC), and urine H. pylori antibody (UHPAb) were dominated by serum H. pylori IgG antibody (SHPAb), rapid urease test (RUT), and urea breath test (UBT). Among three undominated methods, the incremental cost-effective ratios (ICER) of RUT versus SHPAb and UBT versus RUT were $214 and $1914, respectively. If the prevalence of CAM-sensitive H. pylori was less than 55%, BC was not dominated, but its H. pylori eradication success rate was 0.86. Conclusions. RUT was the most cost-effective at the current prevalence of CAM-resistant H. pylori. BC could not be selected due to its poor effectiveness even if CAM-resistant H. pylori was more than 45%.
Collapse
|
|
10
|
Validation of Urine Test for Detection of Helicobacter pylori Infection in Indonesian Population. BIOMED RESEARCH INTERNATIONAL 2015; 2015:152823. [PMID: 26824034 PMCID: PMC4707432 DOI: 10.1155/2015/152823] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 08/13/2015] [Revised: 11/25/2015] [Accepted: 11/30/2015] [Indexed: 01/06/2023]
Abstract
We measured the accuracy of the urine test (RAPIRUN) for detection of Helicobacter pylori infection in Indonesia (Jakarta, Pontianak, and Jayapura) using histology confirmed by immunohistochemistry and/or culture as gold standards. We also used immunohistochemistry to identify CagA phenotype and analyzed H. pylori CagA diversity in Indonesia. The overall prevalence of H. pylori infection in 88 consecutive dyspeptic patients based on the urine test was 15.9% (14/88), 38.1% for patients in Jayapura that had higher prevalence of H. pylori infection than that in Jakarta (9.7%, P = 0.02) and Pontianak (8.3%, P = 0.006). Overall sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of RAPIRUN were 83.3%, 94.7%, 71.4%, 97.3%, and 93.2%, respectively. All of the H. pylori-positive patients were immunoreactive for anti-CagA antibody but not immunoreactive for East Asian specific anti-CagA antibody in all H. pylori-positive subjects. We confirmed the high accuracy of RAPIRUN in Indonesian population. In general, we found less virulent type of H. pylori in Indonesia, which partly explained the low incidence gastric cancer in Indonesia.
Collapse
|
|
11
|
Tamura T, Morita E, Kawai S, Sasakabe T, Sugimoto Y, Fukuda N, Suma S, Nakagawa H, Okada R, Hishida A, Naito M, Hamajima N, Wakai K. No association between Helicobacter pylori infection and diabetes mellitus among a general Japanese population: a cross-sectional study. SPRINGERPLUS 2015; 4:602. [PMID: 26543737 PMCID: PMC4627969 DOI: 10.1186/s40064-015-1371-2] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 06/10/2015] [Accepted: 09/24/2015] [Indexed: 02/07/2023]
Abstract
Several case-control studies have reported that patients with diabetes mellitus (DM) had a higher prevalence of Helicobacter pylori infection than those without DM, but these findings remain equivocal. Additionally, there are few studies examining associations between East Asian CagA-positive H. pylori and DM. This cross-sectional study aimed to investigate whether H. pylori infection was a possible risk factor for DM in a general Japanese population. The study included 5165 subjects (1467 men, 3698 women) aged 35–69 years from the Daiko Study, part of the Japan Multi-Institutional Collaborative Cohort Study. A urinary anti-H. pylori antibody was used to detect H. pylori infection. The medical history of physician-diagnosed DM was confirmed by self-administered questionnaire. The odds ratios (ORs) and their 95 % confidence intervals (CIs) for DM (current and former) were calculated using unconditional logistic regression analysis, adjusting for age, sex, educational status, alcohol use, smoking status, body mass index, energy intake, and physical activity. The prevalence of DM was 4.6 % (95 % CI 3.7–5.6 %) among 1878 participants with H. pylori infection and 3.2 % (2.6–3.8 %) among 3287 without the infection (p = 0.009). The crude, age-adjusted, and multivariate-adjusted ORs for DM in those with the infection relative to those without were 1.47 (95 % CI 1.10–1.97), 1.02 (0.76–1.38), and 0.97 (0.71–1.32), respectively. We found a significantly higher DM prevalence among those with H. pylori infection than among those without. However, almost all the difference in prevalence could be explained by the older age of those infected. Our findings did not support an association between H. pylori infection and DM.
Collapse
Affiliation(s)
- Takashi Tamura
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550 Japan ; Department of Epidemiology and Preventive Medicine, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu, 501-1194 Japan
| | - Emi Morita
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550 Japan ; Environmental Planning Laboratory, Department of Forest Management, Forestry and Forest Products Research Institute, National Research and Development Agency, 1 Matsunosato, Tsukuba, 305-8687 Japan
| | - Sayo Kawai
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550 Japan
| | - Tae Sasakabe
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550 Japan
| | - Yuka Sugimoto
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550 Japan
| | - Nana Fukuda
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550 Japan
| | - Shino Suma
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550 Japan ; Department of Oral Disease Research, National Center for Geriatrics and Gerontology, 7-430 Morioka-cho, Obu, 474-8511 Japan
| | - Hiroko Nakagawa
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550 Japan ; Division of Epidemiology and Prevention, Aichi Cancer Center Research Institute, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681 Japan
| | - Rieko Okada
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550 Japan
| | - Asahi Hishida
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550 Japan
| | - Mariko Naito
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550 Japan
| | - Nobuyuki Hamajima
- Department of Healthcare Administration, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550 Japan
| | - Kenji Wakai
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550 Japan
| |
Collapse
|
|
12
|
Akamatsu T, Okamura T, Iwaya Y, Suga T. Screening to Identify and Eradicate Helicobacter pylori Infection in Teenagers in Japan. Gastroenterol Clin North Am 2015; 44:667-76. [PMID: 26314676 DOI: 10.1016/j.gtc.2015.05.008] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/21/2023]
Abstract
The purpose of this study was to elucidate the prevalence and effect of Helicobacter pylori infection in Japanese teenagers. The study subjects were students ages 16 to 17 from one high school studied between 2007 and 2013. Students who tested positive on this screening examination underwent esophagogastroduodenoscopy and biopsy samples to determine their H pylori status using culture and histology. Cure of H pylori infections was determined by urea breath test. The low rate of prevalence of H pylori infection in present Japanese teenagers makes it possible and cost effective to perform examinations and carry out treatment of this infection in nationwide health screenings of high school students.
Collapse
Affiliation(s)
- Taiji Akamatsu
- Endoscopy Center, Suzaka Prefectural Hospital, Nagano Prefectural Hospital Organization, 1332 Suzaka, Suzaka, Nagano 382-0091, Japan; Gastroenterology, Department of Internal Medicine, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan.
| | - Takuma Okamura
- Gastroenterology, Department of Internal Medicine, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan
| | - Yugo Iwaya
- Gastroenterology, Department of Internal Medicine, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan
| | - Tomoaki Suga
- Gastroenterology, Department of Internal Medicine, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan
| |
Collapse
|
|
13
|
Quach DT, Hiyama T, Shimamoto F, Le QD, Ho LX, Vu NHT, Yoshihara M, Uemura N. Value of a new stick-type rapid urine test for the diagnosis of Helicobacter pylori infection in the Vietnamese population. World J Gastroenterol 2014; 20:5087-5091. [PMID: 24803823 PMCID: PMC4009545 DOI: 10.3748/wjg.v20.i17.5087] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/28/2013] [Revised: 02/22/2014] [Accepted: 03/04/2014] [Indexed: 02/06/2023] Open
Abstract
AIM To assess the value of a new test for the diagnosis of Helicobacter pylori (H. pylori) infection, Rapirun H. pylori Antibody Stick (Rapirun Stick), in a Vietnamese population. METHODS Eligible patients without previous history of H. pylori eradication were recruited. Rapid urease test (RUT) and histologic examination were used to diagnose the H. pylori infection. Patients were considered H. pylori positive when the RUT results were positive and/or the bacteria were detected histologically. Rapirun Stick tests were performed using urine samples, and the results were compared with the other 2 methods. RESULTS We enrolled 200 patients with a mean age of 36 (range, 18-76) years. There were 116 females and 84 males. Of the 200 patients, 111 (55.5%) were diagnosed as being H. pylori positive. The sensitivity, specificity, and accuracy of the Stick test were 84.7%, 89.9%, and 87.0%, respectively. There were 17 (8.5%) false-negative patients and 9 (4.5%) false-positive patients. CONCLUSION The Rapirun Stick test has high sensitivity, specificity, and accuracy for the diagnosis of H. pylori infection in the Vietnamese population. The test can be clinically applied in Vietnamese populations.
Collapse
|
|
14
|
Okuda M, Kamiya S, Booka M, Kikuchi S, Osaki T, Hiwatani T, Maekawa K, Fukuda Y. Diagnostic accuracy of urine-based kits for detection of Helicobacter pylori antibody in children. Pediatr Int 2013; 55:337-41. [PMID: 23360308 DOI: 10.1111/ped.12057] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/29/2012] [Revised: 12/13/2012] [Accepted: 12/20/2012] [Indexed: 12/18/2022]
Abstract
BACKGROUND Rapid urine-HpAb is reported to be a reliable test of Helicobacter pylori infection in adults, but there are no data on the application of the test in children. The aim of this study was to evaluate the accuracy of a urine-based enzyme-linked immunosorbent assay (urine-HpELISA) and immunochromatography (rapid urine-HpAb) kit for anti-H. pylori immunoglobulin G antibody in children. We compared its sensitivity and specificity in reference to the (13) C-urea-breath test (UBT) and H. pylori stool antigen test (HpSA). METHODS In total, 101 Japanese children without significant upper-abdominal symptoms were included (mean age, 7.1 years; range 2-15 years). Their sensitivity and specificity were evaluated in reference to the UBT and HpSA. RESULTS Thirty-seven children were judged H. pylori-positive and 64 negative by the UBT and HpSA. No discrepancy in the results was observed between UBT and HpSA. Urine-HpELISA showed 91.9% sensitivity and 96.9% specificity with an accuracy of 95.0%. Rapid urine-HpAb showed 78.4% sensitivity and 100% specificity with an accuracy of 92.1%. Seven false negative results for rapid urine-HpAb were from children aged younger than 10 years, and their antibody titers of urine-HpELISA were lower than true positives. CONCLUSIONS For the diagnosis of H. pylori infection in Japanese children, both tests are non-invasive, inexpensive, reliable and easy-to-perform methods giving satisfactory accuracy, although the sensitivity of the rapid urine-HpAb kit was inferior to that of the urine-HpELISA kit, especially in children aged younger than 10 years, showing relatively low titer of H. pylori antibody.
Collapse
Affiliation(s)
- Masumi Okuda
- Department of General Medicine and Community Health Science, Hyogo College of Medicine, Sasayama, Japan.
| | | | | | | | | | | | | | | |
Collapse
|
|
15
|
Olasagasti F, Ruiz de Gordoa JC. Miniaturized technology for protein and nucleic acid point-of-care testing. Transl Res 2012; 160:332-45. [PMID: 22683416 PMCID: PMC7104926 DOI: 10.1016/j.trsl.2012.02.012] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/29/2011] [Revised: 02/22/2012] [Accepted: 02/24/2012] [Indexed: 01/26/2023]
Abstract
The field of point-of-care (POC) testing technology is developing quickly and producing instruments that are increasingly reliable, while their size is being gradually reduced. Proteins are a common target for POC analyses and the detection of protein markers typically involves immunoassays aimed at detecting different groups of proteins such as tumor markers, inflammation proteins, and cardiac markers; but other techniques can also be used to analyze plasma proteins. In the case of nucleic acids, hybridization and amplification strategies can be used to record electromagnetic or electric signals. These techniques allow for the identification of specific viral or bacterial infections as well as specific cancers. In this review, we consider some of the latest advances in the analysis of specific nucleic acid and protein biomarkers, taking into account their trend toward miniaturization and paying special attention to the technology that can be implemented in future applications, such as lab-on-a-chip instruments.
Collapse
Key Words
- poc, point-of-care
- lfi, lateral flow immunochromatography
- psa, prostate-specific antigen
- hcg, human chorionic gonadotropin
- tsh, thyroid-stimulating hormone
- seb, staphylococcal enterotixin b
- fret, förster resonance energy transfer
- mmp, matrix metalloproteinase 9
- bnp, b-type natriuretic peptide
- crp, c-reactive protein
- pdms, polydimethylsiloxane
- ig, immunoglobulin
- hb a1c, hemoglobin a1c
- ag, antigen
- ab, antibody
- tnfα, tumor necrosis factor α
- pct, procalcitonin
- il, interleukin
- pcr, polymerase chain reaction
- ca, cancer antigen
- cea, carcinoembryonic antigen
- nmp, nuclear matrix protein
- s100β, s100 calcium binding protein beta
- elisa, enzyme-linked immunosorbent assay
- vegf, vascular endothelial growth factor
- pmma, methyl methacrylate
- ctni, cardiac troponin i
- egf, epidermal growth factor
- ip, interferon-inducible
- mcp, monocyte chemoattractant protein
- timp-1, tissue inhibitor of matrix metalloproteinase-1
- rantes, regulated upon activation, normal t cell expressed and secreted
- mip-1 β, macrophage inflammatory protein-beta
- ctnt, cardiac troponin t
- hrp, horseradish peroxidase
- si-fet, silicon field-effect-transistor
- afp, alpha fetoprotein
- act, antichymotrypsin
- mia, magnetic immunoassay
- apc, allophycocyanin
- he4, human epididymis protein 4
- tmb, 3,3',5,5'-tetramethylbenzidine
- hp, hairpin
- lamp, loop-mediated isothermal amplification
- mrsa, methicillin resistant staphylococcus aureus
- fmdv, foot-and-mouth disease virus
- mμlamp, multiplex microfluidic lamp
- had, helicase-dependent amplification
- nasba, nucleic acid sequence based amplification
- lfm, lateral flow chromatography microarrays
- hsp, heat shock proteins
- spr, surface plasmon resonance
- mems, micro-electro-mechanical systems
- mimed, magnetic integrated microfluidic electrochemical detectors
Collapse
Affiliation(s)
- Felix Olasagasti
- Department of Biochemistry and Molecular Biology, Farmazia Fakultatea/Facultad de Farmacia, UPV-EHU, Gasteiz, Spain.
| | | |
Collapse
|
|
16
|
Sakurai K, Nagahara A, Inoue K, Akiyama J, Mabe K, Suzuki J, Habu Y, Araki A, Suzuki T, Satoh K, Nagami H, Harada R, Tano N, Kusaka M, Fujioka Y, Fujimura T, Shigeto N, Oumi T, Miwa J, Miwa H, Fujimoto K, Kinoshita Y, Haruma K. Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS). BMC Gastroenterol 2012; 12:42. [PMID: 22548767 PMCID: PMC3419613 DOI: 10.1186/1471-230x-12-42] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/11/2011] [Accepted: 05/01/2012] [Indexed: 12/15/2022] Open
Abstract
BACKGROUND In Japan, treatment guidelines are lacking for patients with upper gastrointestinal symptoms. We aimed to compare the efficacy of different drugs for the treatment of uninvestigated upper gastrointestinal symptoms. METHODS This was a randomized, open-label, parallel-group multicenter study. Helicobacter pylori-negative, endoscopically uninvestigated patients ≥ 20 years of age with upper gastrointestinal symptoms of at least moderate severity (Global Overall Symptom score [GOS] ≥ 4 on a 7-point Likert scale) were randomized to treatment with omeprazole (10 mg once daily), famotidine (10 mg twice daily), mosapride (5 mg three times daily) or teprenone (50 mg three times daily). The primary endpoint was sufficient relief of upper gastrointestinal symptoms after 4 weeks of treatment (GOS ≤ 2). UMIN clinical trial registration number: UMIN000005399. RESULTS Of 471 randomized patients, 454 were included in the full analysis set. After 4 weeks of treatment, sufficient symptom relief was achieved by 66.9% of patients in the omeprazole group, compared with 41.0%, 36.3% and 32.3% in the famotidine, mosapride and teprenone groups, respectively (all, p < 0.001 vs omeprazole). There were no treatment-related adverse events. CONCLUSIONS The favorable efficacy and safety profiles of omeprazole in relieving uninvestigated upper gastrointestinal symptoms support its use as first-line treatment in this patient group in Japan. Patients who show no improvement in symptoms despite PPI use, and those with alarm symptoms (such as vomiting, GI bleeding or acute weight loss) should receive further investigation, including prompt referral for endoscopy. TRIAL REGISTRATION UMIN000005399.
Collapse
Affiliation(s)
- Kouichi Sakurai
- Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Kumamoto, 860-8556, Japan
| | - Akihito Nagahara
- Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan
| | - Kazuhiko Inoue
- Internal Medicine, Matsue Red Cross Hospital, Matsue, Japan
- Department of General Medicine, Kawasaki Medical School, Kurashiki, Japan
| | - Junichi Akiyama
- Department of Gastroenterology, International Medical Centre, Tokyo, Japan
| | - Katsuhiro Mabe
- Department of Internal Medicine, Yamagata Prefectural Central Hospital, Yamagata, Japan
- Department of Gastroenterology, Hokkaido University, Sapporo, Japan
| | - Junichi Suzuki
- Department of Gastroenterology, KKR Sapporo Medical Center, Sapporo, Japan
| | - Yasuki Habu
- Department of Gastroenterology, Saiseikai Noe Hospital, Osaka, Japan
| | - Akihiro Araki
- Department of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan
| | - Tsuyoshi Suzuki
- Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan
| | - Katsuaki Satoh
- Satoh Gastrointestinal Surgical Hospital, Kurashiki, Japan
| | | | - Ryosaku Harada
- Gastrointestinal Division, Harada Internal Medicine, Tosu, Japan
| | - Nobuo Tano
- Department of Internal Medicine, Kyoritsu Hospital, Kawanishi, Japan
| | | | | | | | - Nobuyuki Shigeto
- Department of Internal Medicine, Tamano City Hospital, Tamano, Japan
| | | | - Jun Miwa
- Department of Internal Medicine, Toshiba Hospital, Tokyo, Japan
| | - Hiroto Miwa
- Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
| | - Kazuma Fujimoto
- Department of Internal Medicine, Gastrointestinal Endoscopy, Saga Medical School, Saga, Japan
| | - Yoshikazu Kinoshita
- Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan
| | - Ken Haruma
- Division of Gastroenterology, Department of Internal Medicine, Kawasaki Medical School, Kurashiki, Japan
| |
Collapse
|
|
17
|
Tamura T, Morita E, Kondo T, Ueyama J, Tanaka T, Kida Y, Hori Y, Inoue S, Tomita K, Okada R, Kawai S, Hishida A, Naito M, Wakai K, Hamajima N. Prevalence of Helicobacter pylori infection measured with urinary antibody in an urban area of Japan, 2008-2010. NAGOYA JOURNAL OF MEDICAL SCIENCE 2012; 74:63-70. [PMID: 22515112 PMCID: PMC4831251] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 10/31/2022]
Abstract
Helicobacter pylori (H. pylori) has expanded to infect about half the world's population. Although there were many studies on the prevalence of H. pylori infection for defined areas in the 1990s throughout the world, there were only limited sources tracking its latest prevalence among large populations. In the present study, we estimated the prevalence of H. pylori among the inhabitants of Nagoya, an urban area of Japan. Study subjects were 5167 participants (1467 males and 3700 females) aged 35 to 69 years from the Daiko Study, a part of the Japan Multi-Institutional Collaborative Cohort Study (J-MICC Study). A urinary anti-H. pylori antibody was used to detect H. pylori infection. The history of eradication treatments for H. pylori infection was obtained using self-administered questionnaires. The prevalence detected by the urinary test included 19.6% (95% confidence interval; 16.8-22.6%) for those aged 35-39 years, 25.8% (23.5-28.2%) for 40-49 years, 39.4% (36.8-42.1%) for 50-59 years, 50.3% (47.8-52.7%) for 60-69 years, and 36.4% (35.1-37.7%). Among 5167 participants, 266 (5.1%) stated that they had received an eradication treatment. Since 167 subjects with negative urinary tests replied that they had been seropositive for H. pylori in the past, they were included among the ever-infected inhabitant group. Consequently, the overall rate of those with a history of persistent infection was 39.6% (38.3-40.9%). The prevalence of H. pylori infection observed in Nagoya seemed to be lower than the corresponding prevalence reported in other studies of Japan. That lower rate might be due to the reduced exposure from improved urban sanitary conditions.
Collapse
Affiliation(s)
- Takashi Tamura
- Department of Preventive Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Collapse
|
|
18
|
Ly SY, Yoo HS, Choa SH. Diagnosis of Helicobacter pylori bacterial infections using a voltammetric biosensor. J Microbiol Methods 2011; 87:44-8. [DOI: 10.1016/j.mimet.2011.07.002] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/02/2011] [Revised: 06/26/2011] [Accepted: 07/05/2011] [Indexed: 11/26/2022]
|
|
19
|
Evaluation of rapid urine test for the detection of Helicobacter pylori infection in the Vietnamese population. Dig Dis Sci 2010; 55:89-93. [PMID: 19241167 DOI: 10.1007/s10620-009-0720-9] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/23/2008] [Accepted: 01/12/2009] [Indexed: 12/16/2022]
Abstract
PURPOSE This study attempted to assess the value of the RAPIRUN test for the diagnosis of Helicobacter pylori infection in the Vietnamese population. METHODS We recruited 148 Vietnamese patients undergoing upper gastrointestinal endoscopy during which five gastric biopsies were taken; blood and urine samples were collected from each patient. Helicobacter pylori infection status was determined by a combination of three different methods, including culture, immunohistochemistry, and serum ELISA. RAPIRUN tests were performed using urine samples. RESULTS The sensitivity, specificity, and accuracy of the RAPIRUN test in these Vietnamese patients were 79.5, 90.7, and 84.5%, respectively. CONCLUSIONS The RAPIRUN test is useful for the diagnosis of H. pylori infection in the Vietnamese population, showing high specificity, acceptable sensitivity, non-invasiveness, convenience, and rapidity.
Collapse
|
|
20
|
Leal YA, Flores LL, García-Cortés LB, Cedillo-Rivera R, Torres J. Antibody-based detection tests for the diagnosis of Helicobacter pylori infection in children: a meta-analysis. PLoS One 2008; 3:e3751. [PMID: 19015732 PMCID: PMC2582133 DOI: 10.1371/journal.pone.0003751] [Citation(s) in RCA: 45] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/29/2008] [Accepted: 10/26/2008] [Indexed: 01/11/2023] Open
Abstract
Background Numerous serologic tests are available for the diagnosis of H. pylori infection in children. Common designs of antibody-based detection tests are ELISA and Western Blot (WB). For developing countries with limited laboratory resources and access, ELISA would be the preferred method because of its simplicity, lower cost and speed. Although in adults ELISA has proven to be highly accurate in diagnosing H. pylori infection; in children, it has shown variable accuracy. Methods/Findings We conducted a systematic review and meta-analysis to assess the accuracy of antibody-based detection tests for the diagnosis of H. pylori infection in children. Selection criteria included participation of at least 30 children and the use of a gold standard for H. pylori diagnosis. In a comprehensive search we identified 68 studies. Subgroup analyses were carried out by technique, immunoglobulin class, and source of test (commercial and in-house). The results demonstrated: 1) WB tests showed high overall performance, sensitivity 91.3% (95% CI, 88.9–93.3), specificity 89% (95% CI, 85.7–91.9), LR+ 8.2 (95% CI, 5.1–13.3), LR− 0.06 (95% CI, 0.02–0.16), DOR 158.8 (95% CI, 57.8–435.8); 2) ELISA-IgG assays showed low sensitivity 79.2% (95% CI, 77.3–81.0) and high specificity (92.4%, 95% CI, 91.6–93.3); 3) ELISA commercial tests varied widely in performance (test for heterogeneity p<0.0001); and 4) In-house ELISA with whole-cell antigen tests showed the highest overall performance: sensitivity 94% (95% CI, 90.2–96.7), specificity 96.4% (95% CI, 94.2–97.9), LR+ 19.9 (95% CI, 7.9–49.8), LR− 0.08 (95% CI, 0.04–0.15) DOR 292.8 (95% CI, 101.8–841.7). Conclusions/Significance WB test and in-house ELISA with whole-cell antigen tests are the most reliable tests for the diagnosis of H. pylori infection in children. Antigens obtained from local strains of the community could partially explain the good overall accuracy of the in-house ELISA. Because of its cost and technical demands, in-house ELISA might be more suitable for use in developing countries.
Collapse
Affiliation(s)
- Yelda A Leal
- Unidad de Investigación Médica Yucatán (UIMY), Unidad Médica de Alta Especialidad de Mérida, Instituto Mexicano del Seguro Social, Mérida, Yucatán, México.
| | | | | | | | | |
Collapse
|
|
21
|
Yamamoto T, Ishii T, Sanaka M, Kuyama Y. Diagnosis of Helicobacter pylori infection using RAPIRUN H. pylori antibody detection kit. Expert Rev Mol Diagn 2008; 8:565-569. [PMID: 18785804 DOI: 10.1586/14737159.8.5.565] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/04/2025]
Abstract
Accurate diagnosis of Helicobacter pylori infection is essential in today's clinical settings. Additionally, because of the widespread prevalence of this infection, noninvasive and convenient techniques are required for screening purposes. RAPIRUN H. pylori antibody detection kit (Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan) enables a diagnosis within 20 min using a random, single-voided urine specimen. Thus it is especially suited for use in point-of-care settings. The sensitivity and specificity are acceptable and comparable with other available methods. Here we provide an overview of the RAPIRUN kit.
Collapse
Affiliation(s)
- Takatsugu Yamamoto
- Department of Internal Medicine, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan.
| | | | | | | |
Collapse
|
|
22
|
Li JJ, Ouellette AL, Giovangrandi L, Cooper DE, Ricco AJ, Kovacs GTA. Optical scanner for immunoassays with up-converting phosphorescent labels. IEEE Trans Biomed Eng 2008; 55:1560-71. [PMID: 18440902 DOI: 10.1109/tbme.2007.914674] [Citation(s) in RCA: 27] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/07/2022]
Abstract
A 2-D optical scanner was developed for the imaging and quantification of up-converting phosphor (UCP) labels in immunoassays. With resolution better than 500 microm, a scan rate of 0.4 mm/s, and a 1-2% coefficient of variation for repeatability, this scanner achieved a detection limit of fewer than 100 UCP particles in an 8.8. x 10(4) microm(2) area and a dynamic range that covered more than three orders of magnitude. Utilizing this scanner, a microfluidic chip immunoassay for the cytokine interferon-gamma (IFN-gamma) was developed: concentrations as low as 3 pM (50 pg/mL) were detected from 100 microL samples with a total assay time of under an hour, including the 8 min readout. For this UCP-based assay, 2-D images of the capture antibody lines were scanned, image processing techniques were employed to extract the UCP emission signals, a response curve that spanned 3-600 pM IFN-gamma was generated, and a five-parameter logistic mathematical model was fitted to the data for determination of unknown IFN-gamma concentrations. Relative to common single-point or 1-D scanning optical measurements, our results suggest that a simple 2-D imaging system can speed assay development, reduce errors, and improve accuracy by characterizing the spatial distribution and uniformity of surface-captured optical labels as a function of assay conditions and device parameters.
Collapse
Affiliation(s)
- Janice J Li
- Department of Electrical Engineering, Stanford University, Stanford, CA 94305, USA.
| | | | | | | | | | | |
Collapse
|
|
23
|
Mégraud F, Lehours P. Helicobacter pylori detection and antimicrobial susceptibility testing. Clin Microbiol Rev 2007; 20:280-322. [PMID: 17428887 PMCID: PMC1865594 DOI: 10.1128/cmr.00033-06] [Citation(s) in RCA: 486] [Impact Index Per Article: 27.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
The discovery of Helicobacter pylori in 1982 was the starting point of a revolution concerning the concepts and management of gastroduodenal diseases. It is now well accepted that the most common stomach disease, peptic ulcer disease, is an infectious disease, and all consensus conferences agree that the causative agent, H. pylori, must be treated with antibiotics. Furthermore, the concept emerged that this bacterium could be the trigger of various malignant diseases of the stomach, and it is now a model for chronic bacterial infections causing cancer. Most of the many different techniques involved in diagnosis of H. pylori infection are performed in clinical microbiology laboratories. The aim of this article is to review the current status of these methods and their application, highlighting the important progress which has been made in the past decade. Both invasive and noninvasive techniques will be reviewed.
Collapse
Affiliation(s)
- Francis Mégraud
- INSERM U853, and Université Victor Segalen Bordeaux 2, and Laboratoire de Bactériologie, Hôpital Pellegrin, Place Amélie Raba-Léon, 33076 Bordeaux cedex, France.
| | | |
Collapse
|
|
24
|
Lu CY, Kuo FC, Wang SW, Lo YC, Wu IC, Chang LL, Yu FJ, Su YC, Wang WM, Jan CM, Wu DC. The clinical applications and accuracy of 2 rapid near-patient tests in detecting Helicobacter pylori infection. Diagn Microbiol Infect Dis 2006; 56:241-6. [PMID: 16757144 DOI: 10.1016/j.diagmicrobio.2006.04.008] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/03/2006] [Revised: 04/10/2006] [Accepted: 04/10/2006] [Indexed: 02/08/2023]
Abstract
Noninvasive methods for assessing Helicobacter pylori infection status are now an integral part of managing patients with upper gastrointestinal complaints. The aim of this study is to evaluate the feasibility and diagnostic accuracy of 2 rapid tests: a urine-based H. pylori antibody detection method (Rapirun) and a stool-based H. pylori antigen detection method (immunocard STAT! HpSA). The combined use of the mentioned 2 tests was also evaluated, which has not been described in previous similar studies. Urine and stool specimens were collected from patients who were arranged for gastroendoscopic examination. The urine and stool specimens were tested with Rapirun and immunocard STAT! HpSA separately. The estimated reaction time was about 15 to 20 min for the former and 5 to 10 min for the latter. H. pylori infection was confirmed with 4 tests: culture, histology, rapid urease test, and the (13)C-urea breath test. Obtained results from both kits were compared with confirmed results. One hundred twenty patients were eligible for analysis. Of them, 62 tested positive for H. pylori infection and 58 were negative by the confirmation criteria. The urine Rapirun test relative to the confirmed results showed sensitivity, specificity, and accuracy as 87.1% (confidence interval [CI] = 81.1-93.1%), 89.7% (CI = 84.2-95.1%), and 88.3%, respectively. The stool immunocard STAT! HpSA test relative to the confirmed results showed sensitivity, specificity, and accuracy as 96.8% (CI = 93.6-99.9%), 82.8% (CI = 76.0-89.5%), and 90%, respectively. The combined-use method of both tests revealed sensitivity, specificity, and accuracy as 98.4% (CI = 96.1-100%), 81.0% (CI = 74.0-88.1%), and 90%, respectively. These 2 urine and stool tests have a satisfactory accuracy around 90% in detecting H. pylori infection. In consideration of the advantages of cheapness, timesaving, and ease of use, both can be used as rapid near-patient tests in general practice. The combined use of both tests was also promising in detecting H. pylori infection.
Collapse
Affiliation(s)
- Chien-Yu Lu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung City 807, Taiwan
| | | | | | | | | | | | | | | | | | | | | |
Collapse
|
|
25
|
Opekun AR, Luu P, Gotschall AB, Abdalla N, Torres E, Rudd SB, Graham DY, Nurgalieva ZZ, Tsuchiya K. Point-of-care Helicobacter pylori urine antibody detection in a multi-ethnic adult population in the United States. Transl Res 2006; 148:13-8. [PMID: 16887493 DOI: 10.1016/j.lab.2006.03.008] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/30/2005] [Revised: 03/06/2006] [Accepted: 03/06/2006] [Indexed: 12/30/2022]
Abstract
A need exists for accurate point-of-care tests for diagnosis of Helicobacter pylori (H. pylori) infection to evaluate a rapid urine-H. pylori antibody test device for detection of H. pylori infection in a point-of-care setting in the United States. A multi-center study in a multi-ethnic population compared the RAPIRUN urine antibody test with the (13)C-urea breath test (C-UBT) and a traditional serologic test, the high-molecular-weight cell-associated protein enzyme immunoassay (HM-CAP EIA). The primary comparator was with "definite positive" and "definite negative" patients defined as a concordance of combined results of the UBT and the HM-CAP IgG EIA. Overall, 188 eligible patients were enrolled (61 men, age range: 18-73 years, including 84 Hispanics, 73 Asian-Pacific Americans, 22 Black African-Americans, 6 non-Hispanic Caucasians, and 3 of "other" ethnicity). Compared with "definite positive" and "definite negative" results, the sensitivity and specificity of the urine antibody test were 0.9 and 1.0, respectively. The urine antibody test proved suitable for point-of-care rapid diagnosis of anti-H. pylori antibodies indicative of active or past H. pylori infection.
Collapse
|
|
26
|
Yamamoto T, Kojima K, Sanaka M, Ishii T, Osaki Y, Tsutsumi H, Tsuchiya A, Kuyama Y, Uchida S. Reliability of rapid urinary test for antibody to Helicobacter pylori in adult patients with proteinuria. Diagn Microbiol Infect Dis 2006; 54:105-8. [PMID: 16406182 DOI: 10.1016/j.diagmicrobio.2005.09.009] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/02/2005] [Revised: 09/21/2005] [Accepted: 09/26/2005] [Indexed: 01/06/2023]
Abstract
A urinary test for detecting the anti-H. pylori antibody using immunochromatography (RAPIRAN) is considered suitable for the screening purpose. However, this may yield spurious results in the presence of proteinuria. The present study was conducted to evaluate the diagnostic performance of RAPIRAN in patients with proteinuria. Urine and serum samples of adult inpatients with proteinuria were used for analyses. The diagnosis of H. pylori infection was made based on the seropositivity of anti-H. pylori antibody using 2 different serum tests. Fifty-one subjects were eligible for analyses. The serum tests showed negative and positive in 25 and 26 patients, respectively. Two of 25 seropositive patients had a negative result in RAPIRAN, and 1 provided invalid data. All of seronegative patients showed negative in RAPIRAN. The overall accuracy was 95.0%. The present study showed that RAPIRAN has diagnostic quality enough to use clinically also in patients with proteinuria.
Collapse
Affiliation(s)
- Takatsugu Yamamoto
- Department of Internal Medicine, Teikyo University School of Medicine, Itabashi-ku, Tokyo 173-8605, Japan.
| | | | | | | | | | | | | | | | | |
Collapse
|
|
27
|
Sönmezoglu M, Baysal B, Ergen A, Barut SG. Detection and evaluation of salivary antibodies to Helicobacter pylori in dyspeptic patients. Int J Clin Pract 2005; 59:433-6. [PMID: 15853860 DOI: 10.1111/j.1368-5031.2005.00495.x] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/28/2022] Open
Abstract
Helicobacter pylori infection is one of the most prevalent infections in humans. The high prevalence and the association with peptic ulceration and gastric cancer require simple and non-invasive methods for the diagnosis of the infection. Detection of salivary anti-H. pylori IgG antibodies has advantages compared with those on serum. In this study, salivary immunoglobulin G response to H. pylori was evaluated in 100 consecutive dyspeptic patients by enzyme-linked immunosorbent assay (ELISA), in comparison with culture and histopathologic examination of gastric biopsy specimens obtained at endoscopic procedures and assessed the accuracy of salivary diagnosis of the infection. The overall sensitivity and specificity of the test were 87 and 73%, respectively. These results suggest that saliva testing for H. pylori antibodies could be used reliably for screening dyspeptic patients in general practice, especially in children in whom venesection is more difficult.
Collapse
Affiliation(s)
- M Sönmezoglu
- Department of Infectious Diseases, Haseki Hospital, Aksaray, Istanbul, Turkey.
| | | | | | | |
Collapse
|
|
28
|
Yamamoto T, Ishii T, Kawakami T, Sase Y, Horikawa C, Aoki N, Sanaka M, Kuyama Y. Reliability of urinary tests for antibody to Helicobacter pylori in patients with pulmonary tuberculosis. World J Gastroenterol 2005; 11:412-4. [PMID: 15637756 PMCID: PMC4205350 DOI: 10.3748/wjg.v11.i3.412] [Citation(s) in RCA: 44] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
AIM: Although the quality of currently available urinary tests for detecting antibody to Helicobacter pylori (H pylori) have been proved in some populations, the accuracy has not been studied regarding patients who suffer from pulmonary tuberculosis with multi-drug treatments. The present study was conducted to evaluate the accuracy of these urinary tests for antibody to H pylori in these patients.
METHODS: Serum samples from 61 inpatients with pulmonary tuberculosis were tested using enzyme immunoassay, and urine samples were assayed by enzyme-linked immunosorbent assay method (URINELISA) and immunochromatography method (RAPIRAN). Medicines prescribed to the patients were recorded for medical charts, to evaluate the influences on the results of urinary tests.
RESULTS: The sensitivity, specificity, and consistency of URINELISA against the serum test were 93.1%, 65.6%, and 78.6% respectively, and those of RAPIRAN were 86.2%, 93.7%, and 90.1% respectively, which were almost equal to the data previously reported. Prescribed medicines had little influence on the results.
CONCLUSION: The two urinary tests for detecting H pylori antibody have a diagnostic accuracy in patients with pulmonary tuberculosis given multiple anti-tuberculosis drugs.
Collapse
Affiliation(s)
- Takatsugu Yamamoto
- Department of Internal Medicine, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan.
| | | | | | | | | | | | | | | |
Collapse
|
|
29
|
Jiang Z, Huang AL, Tao XH, Wang PL. Diagnosis of Helicobacter pylori infection and diseases associated with Helicobacter pylori by Helicobacter pylori outer membrane proteins. World J Gastroenterol 2004; 10:3464-9. [PMID: 15526366 PMCID: PMC4576228 DOI: 10.3748/wjg.v10.i23.3464] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022] Open
Abstract
AIM: To examine the serological response of patients with upper gastrointestinal diseases and Helicobocter pylori (H pylori) infection to two H pylori outer membrane proteins (OMPs) (Mr18000 and Mr26000) acquired by gene recombinant technique, and to determine the diagnostic significance of serological tests derived from these OMPs.
METHODS: Recombinant vectors encoding the two H pylori OMPs were used to transform and express in BL21 (DE3) E.coli. After purification with Ni2+-NTA agarose resin, colloid gold kits were prepared with purified recombinant proteins to detect H pylori infection and H pylori-associated diseases by the immunity-marker technology. We selected 150 patients with H pylori infection and digestive symptoms without previous treatment, including chronic gastritis (n = 60), duodenal ulcer (n = 30), gastric ulcer (n = 30), and gastric cancer (n = 30). As controls, 33 H pylori-negative healthy volunteers were also recruited. Serum samples were collected from all subjects, and the antibodies to specific proteins of H pylori were tested with the colloid gold test kits. The sensitivity, specificity and accuracy of the colloid gold tests were evaluated, by using the combination of standard diagnostic methods (13C urea breath test and bacteria culture) and classic enzyme-linked immunosorbent assay (ELISA) as reference.
RESULTS: After purification with Ni2+-NTA agarose resin, the purity of recombinant fusion proteins was about 95%. The recombinant fusion proteins were recognized by the specific monoclonal antibodies against the two H pylori OMPs, as demonstrated by the ELISA. Of the 150 serum samples from patients infected with H pylori 141 (94.0%) responded positively to the recombinant protein with Mr26000, while the seropositive rates were 95.0%, 96.7%, 96.7% and 90.0% for patients with H pylori-associated chronic gastritis, duodenal ulcer, gastric ulcer, and gastric cancer respectively. The sensitivity, specificity, and accuracy of the colloid gold kit with Mr26000 protein were 94.0%, 97.0%, and 94.5%, respectively. Compared with the classic ELISA, bacteria culture and 13C urea breath test results in detecting H pylori-infection, there was no significant difference (P > 0.05). For the colloid gold kit with Mr18000, the seropositive rates were 52.0%, 40.0%, 40.0%, 53.3% and 86.7%, respectively, in H pylori-infected patients, and those with H pylori-associated chronic gastritis, duodenal ulcer, gastric ulcer, and gastric cancer. There was a significant difference (P < 0.05) in seropositivity between patient with gastric cancer (86.7%) and those with other diseases (43.3%).
CONCLUSION: The two colloid gold kits derived from the recombinant OMPs are useful tools either for detecting H pylori infection, or for, predicting H pylori-associated gastric malignancy.
Collapse
Affiliation(s)
- Zheng Jiang
- Department of Gastroenterology, the First Affiliated Hospital, Chongqing University of Medical Sciences, Chongqing 400016, China.
| | | | | | | |
Collapse
|
|
30
|
Jiang Z, Huang AL, Zheng J, Tao XH, Pu D, Wang PL. Helicobacter pylori outer membrane proteins in diagnosis of Helicobacter pylori infection. Shijie Huaren Xiaohua Zazhi 2004; 12:1588-1592. [DOI: 10.11569/wcjd.v12.i7.1588] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
AIM: To examine the serological response of patient with various upper gastrointestinal diseases and Helicobacter pylori (H. pylori ) infection to H. pylori outer membrane proteins (OMP) with Mr18 000 and 26 000 acquired by gene recombinant technique, and to determine its diagnostic significance.
METHODS: The recombinant vectors encoding OMP of H. pylori with Mr18 000 and 26 000 identified by restriction enzyme or PCR were used to transform and express in BL21 (DE3) E. coli respectively. After purification with Ni2+-NTA agarose resin, the colloid gold kits were prepared with purified recombinant proteins to detect H. pylori infection and disease associated with H. pylori by immunity-marker technology. We selected 150 patients with H. pylori infection and digestive symptoms without previous treatment, including chronic superficial gastritis (n = 60), duodenal ulcer (n = 30), gastric ulcer (n = 30), and gastric cancer (n = 30) during one year. Simultaneously, 33 cases without digestive symptoms and H. pylori infection were used as controls. All sera were collected and the antibody responded to specific proteins of H. pylori was tested with the colloid gold test kit. Taking as reference a combination of standard diagnostic methods (13C urea breath test, cultivate) and the classic enzyme-linked immunosorbent assay (ELISA) serological tests was compared with the results of this technique, and the sensitivity, specificity and accuracy of the colloid gold test were evaluated.
RESULTS: After purification with Ni2+-NTA agarose resin, the purities of recombinant fusion proteins were all about 95%. The ELISA results showed that recombinant fusion proteins could be recognized by monoclonal antibody of anti-H. pylori with Mr18 000 and 26 000 respectively. The results detected using colloid gold kits were as follows: all patients sera infected with H. pylori showed response to recombinant protein with Mr 26 000 were 94.0%, while 95.0%, 96.7%, 96.7% and 90.0% of patients with H. pylori-infected chronic superficial gastritis, duodenal ulcer, gastric ulcer, and gastric cancer respectively, showed responses. Compared with the serum-based ELISA results in detecting H. pylori-infection, there was no significant difference with the colloid gold kits (P > 0.05). The sensitivity, specificity, and accuracy of the rapid test kit with Mr 26 000 protein were 94.0%, 97.0%, and 94.5%, respectively; To recombinant protein with Mr18 000, 52.0%, 40.0%, 40.0%, 53.3% and 86.7%, of patients with H. pylori-infected chronic superficial gastritis, duodenal ulcer, gastric ulcer, and gastric cancer respectively, showed responses. There were a significant difference (P < 0.05) in the detecting rates of H. pylori infection between gastric cancer (86.7%) and the other diseases (43.3%). The results showed the colloid gold kits with Mr26 000 proteins of H. pylori could be used as a conventional examination method, with similar sensitivity and specificity as other conventional examination method, and simultaneously a significant association was found between the serologic response to Mr 18 000 OMP antigen and malignant outcome of H. pylori infection.
CONCLUSION: The two colloid gold kits with Mr18 000 and 26 000 proteins of H. pylori, can be a useful tool for detecting H. pylori infection, as well as predicting H. pylori related gastrointestinal diseases, such as gastric malignancy and peptic ulcer.
Collapse
|
|
31
|
Leodolter A, Vaira D, Bazzoli F, Schütze K, Hirschl A, Mégraud F, Malfertheiner P. European multicentre validation trial of two new non-invasive tests for the detection of Helicobacter pylori antibodies: urine-based ELISA and rapid urine test. Aliment Pharmacol Ther 2003; 18:927-31. [PMID: 14616156 DOI: 10.1046/j.1365-2036.2003.01761.x] [Citation(s) in RCA: 34] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/23/2022]
Abstract
AIM Non-invasive tests for the assessment of Helicobacter pylori status are now an integral part of the management strategies for patients with dyspepsia. The aim of this study was to evaluate a urine based antibody ELISA and a near patient urine test for the diagnosis of H. pylori infection in a European population. METHODS Urine samples were collected from 449 patients (240 females, 209 males, mean age 54 years), with dyspeptic symptoms but no previous H. pylori eradication therapy, at five centres in four European countries. All patients underwent GI endoscopy and biopsies were taken for H. pylori diagnosis. Urine samples were analysed using an IgG ELISA (URINELISA) and a near patient urine test (RAPIRUN). In addition, a serum IgG ELISA (Pyloriset-EIA-GIII), a whole blood test (Pyloriset-Screen) and a 13C-urea breath test were performed. RESULTS The sensitivity of the urine based ELISA and the near patient urine test was 90% and 82%, and the specificity 68% and 83%, respectively. The accuracy of the serum ELISA and the whole blood test was comparable with the urine based test. CONCLUSION The urine based ELISA and the near patient urine test are just as accurate as the serological tests. This comparable accuracy and complete non-invasiveness of the former gives it an advantage over blood based tests. This limits the application of these tests in general practice.
Collapse
Affiliation(s)
- A Leodolter
- Department of Gastroenterology, Hepatology and Infectious Diseases, University of Magdeburg, Germany
| | | | | | | | | | | | | |
Collapse
|
|
32
|
Kabir S. Review article: clinic-based testing for Helicobacter pylori infection by enzyme immunoassay of faeces, urine and saliva. Aliment Pharmacol Ther 2003; 17:1345-54. [PMID: 12786628 DOI: 10.1046/j.1365-2036.2003.01577.x] [Citation(s) in RCA: 31] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
Enzyme immunoassays have been used to detect Helicobacter pylori infection in human body materials such as faeces, urine and saliva. The stool antigen assay (HpSA), which uses polyclonal anti-H. pylori antibody as a capture reagent, has been widely used in the pre-treatment diagnosis of the infection in adults and children. Although the assay has the potential for monitoring eradication therapy, there are controversies over its use, especially at an early stage after treatment. The efficacy of the stool antigen assay can be modified by using monoclonal antibodies towards well characterized H. pylori faecal antigens. Two types of enzyme immunoassays (enzyme-linked immunosorbent assay [ELISA] and immunochromatography) have been used to detect antibodies to H. pylori in urine. Immunochromatography of urine is a rapid assay well suited for epidemiological studies. The salivary ELISA, used in a number of studies, has shown inconsistent results with less than optimum sensitivity and specificity. Urinary and salivary immunoassays may not distinguish between past and present infections, thus limiting their potential to monitor eradication therapy.
Collapse
Affiliation(s)
- S Kabir
- Academic Research and Information Management, Stockholm, Sweden.
| |
Collapse
|