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Kato S, Shimizu T, Toyoda S, Gold BD, Ida S, Ishige T, Fujimura S, Kamiya S, Konno M, Kuwabara K, Ushijima K, Yoshimura N, Nakayama Y. The updated JSPGHAN guidelines for the management of Helicobacter pylori infection in childhood. Pediatr Int 2020; 62:1315-1331. [PMID: 32657507 PMCID: PMC7839701 DOI: 10.1111/ped.14388] [Citation(s) in RCA: 54] [Impact Index Per Article: 10.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/20/2020] [Revised: 06/20/2020] [Accepted: 07/06/2020] [Indexed: 02/06/2023]
Abstract
The Japan Pediatric Helicobacter pylori Study Group published the first guidelines on childhood H. pylori infection in 1997. They were later revised by the Japanese Society for Pediatric Gastroenterology, Hepatology and Nutrition (JSPGHAN). The H. pylori eradication rates, when employing triple therapy with amoxicillin and clarithromycin, currently recommended as the first-line therapy of H. pylori infection in Japan, have substantially decreased, creating an important clinical problem worldwide. In Japanese adults, the "test-and-treat" strategy for H. pylori infection is under consideration as an approach for gastric cancer prevention. However, the combined North American and European pediatric guidelines have rejected such a strategy for asymptomatic children. As risk for gastric cancer development is high in Japan, determining whether the "test-and-treat" strategy can be recommended in children has become an urgent matter. Accordingly, the JSPGHAN has produced a second revision of the H. pylori guidelines, which includes discussion about the issues mentioned above. They consist of 19 clinical questions and 34 statements. An H. pylori culture from gastric biopsies is recommended, not only as a diagnostic test for active infection but for antimicrobial susceptibility testing to optimize eradication therapy. Based upon antimicrobial susceptibility testing of H. pylori strains (especially involving clarithromycin), an eradication regimen including use of the antibiotics to which H. pylori is susceptible is recommended as the first-line therapy against H. pylori-associated diseases. The guidelines recommend against a "test-and-treat" strategy for H. pylori infection for asymptomatic children to protect against the development of gastric cancer because there has been no evidence supporting this strategy.
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Affiliation(s)
- Seiichi Kato
- Kato Children’s ClinicNatoriJapan
- Department of Infectious diseasesKyorin University School of MedicineTokyoJapan
| | - Toshiaki Shimizu
- Department of Pediatrics and Adolescent MedicineJuntendo University Graduate School of MedicineTokyoJapan
| | | | | | - Shinobu Ida
- Department of Pediatric Gastroenterology and EndocrinologyOsaka Women’s and Children’s HospitalOsakaJapan
| | - Takashi Ishige
- Department of PediatricsGunma University Graduate School of MedicineMaebashiJapan
| | - Shigeru Fujimura
- Division of Clinical Infectious Diseases & ChemotherapyTohoku Medical and Pharmaceutical University Graduate School of Pharmaceutical SciencesSendaiJapan
| | - Shigeru Kamiya
- Department of Infectious diseasesKyorin University School of MedicineTokyoJapan
| | - Mutsuko Konno
- Department of PediatricsSapporo Kosei General HospitalSapporoJapan
| | - Kentaro Kuwabara
- Department of PediatricsHiroshima City Hiroshima Citizens HospitalHiroshimaJapan
| | - Kosuke Ushijima
- Department of Pediatrics and Child HealthKurume University School of MedicineKurumeJapan
| | | | - Yoshiko Nakayama
- Department of PediatricsShinshu University School of MedicineMatsumotoJapan
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Best LMJ, Takwoingi Y, Siddique S, Selladurai A, Gandhi A, Low B, Yaghoobi M, Gurusamy KS. 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.
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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
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Obayashi N, Ohtsuka Y, Hosoi K, Ikuse T, Jimbo K, Aoyagi Y, Fujii T, Kudo T, Asaoka D, Hojo M, Nagahara A, Watanabe S, Shimizu T. Comparison of Gene Expression Between Pediatric and Adult Gastric Mucosa with Helicobacter pylori Infection. Helicobacter 2016; 21:114-23. [PMID: 26140656 DOI: 10.1111/hel.12245] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
Abstract
BACKGROUND Although Helicobacter pylori infection among adults is a major risk factor for the development of gastric cancer and initial infection with H. pylori may occur before 5 years of age, the direct effects of H. pylori infection since childhood on gastric mucosa are unknown. The aim of this study was to evaluate gene expression in the H. pylori-infected gastric mucosa of children. METHODS Gastric mucosal samples were obtained from 24 patients (12 adults and 12 children) who had undergone endoscopic evaluation of chronic abdominal complaints and were examined by the adult and pediatric gastroenterologists at Juntendo University Hospital. Six adult and pediatric patients with and six without H. pylori infection were enrolled. Their gastric mucosal samples obtained from the antrum and corpus were used for microarray, real-time polymerase chain reaction, and immunohistochemical analyses to examine the expression of inflammatory carcinogenic molecules. RESULTS The expression of inflammatory molecules was upregulated in the H. pylori-infected gastric mucosa from both adults and children. The expression of olfactomedin-4 was only upregulated in adult patients, while that of pim-2, regenerating islet-derived 3 alpha, lipocalin-2, and C-X-C motif chemokine ligand 13 was equally upregulated in the infected gastric mucosa of both adults and children. CONCLUSIONS Because several carcinogenic molecules are upregulated in H. pylori-infected gastric mucosa even in children, early eradication therapy from childhood may be beneficial to decrease the incidence of gastric cancer. Although increased expression of olfactomedin-4 can be important in suppressing gastric cancer in adults, the increase was not detected in children.
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Affiliation(s)
- Naho Obayashi
- Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Yoshikazu Ohtsuka
- Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Kenji Hosoi
- Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Tamaki Ikuse
- Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Keisuke Jimbo
- Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Yo Aoyagi
- Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Tohru Fujii
- Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Takahiro Kudo
- Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Daisuke Asaoka
- Department of Gastroenterology, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Mariko Hojo
- Department of Gastroenterology, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Akihito Nagahara
- Department of Gastroenterology, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Sumio Watanabe
- Department of Gastroenterology, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Toshiaki Shimizu
- Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan
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Patel SK, Pratap CB, Jain AK, Gulati AK, Nath G. Diagnosis of Helicobacter pylori: What should be the gold standard? World J Gastroenterol 2014; 20:12847-12859. [PMID: 25278682 PMCID: PMC4177467 DOI: 10.3748/wjg.v20.i36.12847] [Citation(s) in RCA: 175] [Impact Index Per Article: 15.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/21/2013] [Revised: 02/10/2014] [Accepted: 06/26/2014] [Indexed: 02/06/2023] Open
Abstract
Since the discovery of Helicobacter pylori (H. pylori) in 1983, numerous detection methods for the presence of the bacterium have been developed. Each one of them has been associated with advantages and disadvantages. Noninvasive tests such as serology, 13C urea breath test (UBT) and stool antigen tests are usually preferred by the clinicians. Serology has its own limitation especially in endemic areas while 13C UBT is technically very demanding. The stool antigen detection method, although specific, is usually associated with poor sensitivity. The 13C UBT is believed to be specific, but with present revelation of the fact that stomach is colonized by many other urease producing bacteria makes it questionable. Histology, culture, rapid urease test and polymerase chain reaction (PCR) are the tests which are carried out on antral biopsies collected by invasive means. Histology has been proposed to be very sensitive and specific but the question is how by simply looking the morphology of the bacteria in the microscope, one can claim that the curved bacterium is exclusively H. pylori. Rapid urease test (RUT), the doctor’s test, is also challenged because the presence of other urease producing bacteria in the stomach cannot be denied. Moreover, RUT has been reported with poor sensitivity specially, when density of the bacterium is low. Isolation of H. pylori is essential to investigate its growth requirements, antibiotic susceptibility testing, studying virulence factor to develop vaccine and many more explorations. It has also got several disadvantages i.e., special condition for transporting, media, incubation and few days waiting for the colonies to appear, apart from the speed essentially needed to process the specimens. Till date, majority of the microbiological laboratories in the world are not equipped and trained to isolate such fastidious bacterium. The option left is PCR methods to detect H. pylori’s DNA in gastric mucosa, gastric juice, saliva, dental plaques and environmental specimens. There are speculations for false positivity due to detection of non-pylori Helicobacters due to genetic sharing; and false negativity due to low bacterial counts and presence of PCR inhibitors. However, specimen collection, transportation and processing do not require speed and special conditions. PCR based diagnosis may be considered as gold standard by designing primers extremely specific to H. pylori and targeting at least more than one conserved genes. Similarly specificity of PCR may be improved by use of internal Primers. Further, nested PCR will take care of false negatives by countering the effect of PCR inhibitors and low bacterial counts. Therefore, nested PCR based methods if performed properly, may be proposed as gold standard test.
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Olszowy P, Buszewski B. Urine sample preparation for proteomic analysis. J Sep Sci 2014; 37:2920-8. [PMID: 25132110 DOI: 10.1002/jssc.201400331] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2014] [Revised: 07/08/2014] [Accepted: 07/18/2014] [Indexed: 12/22/2022]
Abstract
Sample preparation for both environmental and more importantly biological matrices is a bottleneck of all kinds of analytical processes. In the case of proteomic analysis this element is even more important due to the amount of cross-reactions that should be taken into consideration. The incorporation of new post-translational modifications, protein hydrolysis, or even its degradation is possible as side effects of proteins sample processing. If protocols are evaluated appropriately, then identification of such proteins does not bring difficulties. However, if structural changes are provided without sufficient attention then protein sequence coverage will be reduced or even identification of such proteins could be impossible. This review summarizes obstacles and achievements in protein sample preparation of urine for proteome analysis using different tools for mass spectrometry analysis. The main aim is to present comprehensively the idea of urine application as a valuable matrix. This article is dedicated to sample preparation and application of urine mainly in novel cancer biomarkers discovery.
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Affiliation(s)
- Pawel Olszowy
- Department of Environmental Chemistry and Bioanalytics, Faculty of Chemistry, Nicolaus Copernicus University, Torun, Poland; Interdisciplinary Centre for Modern Technologies, Nicolaus Copernicus University, Torun, Poland
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Morimoto Y, Yoshida N, Kawashima N, Matsumoto K, Kato K. Identification of predictive factors for response to intravenous immunoglobulin treatment in children with immune thrombocytopenia. Int J Hematol 2014; 99:597-602. [DOI: 10.1007/s12185-014-1551-9] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/17/2013] [Revised: 02/17/2014] [Accepted: 02/18/2014] [Indexed: 01/07/2023]
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Pourakbari B, Mirsalehian A, Maleknejad P, Mamishi S, Azhdarkosh H, Daryani NE, Najafi M, Kazemi B, Paknejad M, Mahmoudi S, Bandehpour M, Ghazi M, Salavati A. Evaluation of a new antigen for diagnosis of Helicobacter pylori infection in stool of adult and children. Helicobacter 2011; 16:42-6. [PMID: 21241411 DOI: 10.1111/j.1523-5378.2010.00813.x] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
BACKGROUND Nowadays, there is an increasing interest in noninvasive methods to diagnose Helicobacter pylori infection. Indeed, they can profitably replace endoscopy in predicting the diagnosis. The stool antigen test for H. pylori is a noninvasive immunoassay to diagnose active infection with this bacterium in human fecal samples. The aim of this study was detection of alkyl hydroperoxide reductase protein (AhpC) antigen by immunoblotting in stool samples for diagnosis of H. pylori. MATERIALS AND METHODS Chromosomal DNA from H. pylori was isolated. AhpC gene was amplified by PCR, These amplicons were cloned into pTZ57R/T cloning vector then subcloned into pQE30 expression vector and overexpressed using isopropyl-beta-D-thiogalactopyranoside in E. coli M15. AhpC protein was purified by affinity chromatography. Rabbits were immunized with the purified AhpC protein for the production of antibodies. To determine the accuracy of the test for diagnosing H. pylori infection from stool, we evaluated 84 patients (6-81 years old) using Western blot analysis by rabbit anti-AhpC antibody. Positive rapid urease test on biopsy samples was considered as the gold standard. RESULTS AhpC gene was overexpressed, and AhpC protein was purified. Rabbit anti-AhpC antibody produced after immunization with the purified AhpC protein. By immunoblotting, we detected AhpC protein in the positive stool samples. The test showed a 83.3% sensitivity (95% CI: 69.8-92.5%) and a 91.7% specificity (95% CI: 77.5-98.2). Among the children, the sensitivity was 88.2% (95% CI: 63.6-98.5) and the specificity was 100% (95% CI: 69.2-100); in adults, the sensitivity and specificity were 80.6% (95% CI: 62.5-92.5) and 88.5% (95% CI: 69.8-97.6), respectively. CONCLUSIONS Using of AhpC antigen for diagnosis of H. pylori infection is a useful noninvasive method, accurate in adolescents and children, and can be used for the development of a stool antigen detection kit for H. pylori.
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Affiliation(s)
- Babak Pourakbari
- Department of Microbiology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran
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Guarner J, Kalach N, Elitsur Y, Koletzko S. Helicobacter pylori diagnostic tests in children: review of the literature from 1999 to 2009. Eur J Pediatr 2010; 169:15-25. [PMID: 19618211 DOI: 10.1007/s00431-009-1033-x] [Citation(s) in RCA: 98] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/28/2009] [Accepted: 07/08/2009] [Indexed: 02/07/2023]
Abstract
The array of tests that can be used for diagnosis of Helicobacter pylori infection is large, and it can be confusing to define which test to use particularly in children where results may not be comparable to those obtained in adult patients. Using PubMed, we reviewed the English literature from January 1999 to May 2009 to identify articles that determined sensitivity and specificity of H. pylori invasive and non-invasive diagnostic tests in children. We excluded articles that presented a review of the literature, abstracts, case reports, or series where children's results could not be separated from adult populations. Of the tissue based methods, rapid urease tests have better sensitivity than histology to detect presence of H. pylori; however, histology can detect the pathology associated with disease including gastritis, intestinal metaplasia, and other conditions that could be the cause of the child's symptoms. Culture of gastric tissues or stool has 100% specificity but sensitivity is low. Of the serologic tests, immunoblot has the best sensitivity. The urea breath tests have >75% sensitivity for detection of H. pylori before and after treatment. Immunoassays in stool using monoclonal antibodies have >95% sensitivity for detection of H. pylori before and after treatment. PCR testing can be performed in tissue and stool samples and can detect genes associated to antibiotic resistance. In summary, the current commercial non-invasive tests have adequate sensitivity and specificity for detecting the presence of H. pylori; however, endoscopy with histopathology is the only method that can detect H. pylori and lesions associated with the infection.
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Affiliation(s)
- Jeannette Guarner
- Department of Pathology and Laboratory Medicine, Emory University Hospital (rm C179A), 1364 Clifton Rd, Atlanta, GA 30322, USA.
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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.
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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.
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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.
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Affiliation(s)
- Takatsugu Yamamoto
- Department of Internal Medicine, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan.
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Mendoza-Ibarra SI, Perez-Perez GI, Bosques-Padilla FJ, Urquidi-Rivera M, Rodríguez-Esquivel Z, Garza-González E. Utility of diagnostic tests for detection of Helicobacter pylori in children in northeastern Mexico. Pediatr Int 2007; 49:869-74. [PMID: 18045288 DOI: 10.1111/j.1442-200x.2007.02488.x] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
BACKGROUND The presence of Helicobacter pylori in pediatric population has been associated with recurrent abdominal pain (RAP), although this association is unclear. One of the major problems in studying the role of H. pylori in RAP is that methods used to detect the bacteria in children have poor sensitivity and specificity. The aims of the present study were to determine the prevalence of H. pylori in pediatric patients with RAP in northeastern Mexico and to assess the diagnostic utility of invasive tests and serology in this population. METHODS A total of 40 patients (mean age, 7.9 years; range 2-16 years; F: M, 0.81), who underwent an endoscopy procedure for RAP, were studied. The presence of H. pylori was assessed using invasive diagnostic tests (culture, rapid urease test, polymerase chain reaction and histology) and one non-invasive test: determination of IgG antibodies. The prevalence of H. pylori in the present group and the diagnostic utility for each test were evaluated. RESULTS The prevalence of H. pylori in the present pediatric group with RAP was 12.5-42.5% depending on the criteria of positivity used. The non-invasive methods (serology) had acceptable values in sensitivity and specificity in comparison with invasive tests. CONCLUSIONS This is the first report on prevalence of H. pylori in pediatric patients with RAP from the northeastern region of Mexico. The prevalence of H. pylori was low compared with the adult population in the same geographic region. Serology had the best diagnostic utility.
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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: 482] [Impact Index Per Article: 26.8] [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.
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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.
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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.
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Affiliation(s)
- Takatsugu Yamamoto
- Department of Internal Medicine, Teikyo University School of Medicine, Itabashi-ku, Tokyo 173-8605, Japan.
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Shimizu T, Yarita Y, Suzuki M, Takahashi K, Ohtsuka Y, Nagata S, Obinata K, Yamashiro Y. Serum and urine Helicobacter pylori antibody titer after intravenous gamma-globulin treatment for Kawasaki disease and its clearance. Pediatr Int 2005; 47:172-4. [PMID: 15771695 DOI: 10.1111/j.1442-200x.2005.02037.x] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Abstract
BACKGROUND It is not clear the effect of gamma-globulin therapy on results of enzyme-linked immunosorbent assays (ELISA) based on serum and urine for detection of Helicobacter pylori (H. pylori) antibodies, although the therapy can cause false-positive results in those assays. METHODS To examine the effect of intravenous gamma-globulin (IVIG) treatment on the results of ELISA based on serum and urine, levels of H. pylori IgG were measured in the serum and urine before and after IVIG therapy in 18 children with Kawasaki disease (KD) uninfected with H. pylori. RESULTS The serum and urine H. pylori IgG levels decreased time-dependently after the IVIG therapy and there were significant differences (P < 0.01) in the levels prior to therapy and at 7 days and 1 month after the therapy. The significant difference in the H. pylori IgG levels prior to therapy and 3 months after the therapy was observed in the serum but not in the urine. CONCLUSION The results suggest that gamma-globulin administration can cause false-positive results in ELISA based both on serum and urine for detection of H. pylori antibodies, and that the H. pylori antibodies cleared much more quickly from the urine than from the serum.
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Affiliation(s)
- Toshiaki Shimizu
- Department of Pediatrics, Juntendo University School of Medicine, Tokyo 113-0033, Japan.
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Mégraud F. Comparison of non-invasive tests to detect Helicobacter pylori infection in children and adolescents: results of a multicenter European study. J Pediatr 2005; 146:198-203. [PMID: 15689908 DOI: 10.1016/j.jpeds.2004.10.044] [Citation(s) in RCA: 85] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/15/2023]
Abstract
OBJECTIVE To compare the current non-invasive tests for Helicobacter pylori infection in children and adolescents. STUDY DESIGN This multicenter, multinational study investigated the sensitivity, specificity, and positive and negative predictive values of four non-invasive tests: urea breath test (UBT), stool antigen test, and antibody detection in serum and urine, in comparison with biopsy-based tests. RESULTS Of 503 patients included pre-treatment, 473 fulfilled the definition of H pylori status and among those 316 had results available for the four non-invasive tests (including 133 H pylori -positive patients). The specificity was excellent for all tests. The UBT had the best sensitivity in all age groups, followed by serology, stool test, and antibody detection in urine. A trend for better sensitivity with an increase in age was observed except for the stool test. The receiver operating characteristics (ROC) curves showed that sensitivity of serology, stool test, and urinelisa could be improved by changing the cutoff value. An inadequate storage of the specimens may explain the poor results of the stool test. CONCLUSION The UBT appears to be an excellent test for diagnosis of H pylori infection for children and adolescents.
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Affiliation(s)
- Francis Mégraud
- Université Victor Segalen Bordeaux 2, 33076 Bordeaux, France.
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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.
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Affiliation(s)
- Takatsugu Yamamoto
- Department of Internal Medicine, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan.
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Okuda M, Nakazawa T, Booka M, Miyashiro E, Yosikawa N. Evaluation of a urine antibody test for Helicobacter pylori in Japanese children. J Pediatr 2004; 144:196-9. [PMID: 14760261 DOI: 10.1016/j.jpeds.2003.10.057] [Citation(s) in RCA: 28] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
OBJECTIVE To evaluate the accuracy of a urine-based enzyme-linked immunosorbent assay (ELISA) kit for anti-Helicobacter pylori immunoglobulin G antibody (urine-HpELISA) in children, we compared its sensitivity and specificity in reference to (13)C-urea-breath test (UBT) and H pylori stool antigen test (HpSA). STUDY DESIGN Japanese children without significant upper abdominal symptoms were included (n=100; mean age, 7.0 years; range, 2 to 15). UBT, HpSA, and urine-HpELISA were performed. RESULTS Of 100 children, 36 and 64 were judged H pylori-positive and H pylori-negative, respectively, by UBT and HpSA. Thirty-four of 36 positive children were positive by urine-HpELISA, and 62 out of 64 negative children were negative by urine-HpELISA. Thus, the urine-HpELISA had 94.4% sensitivity and 96.9% specificity, with accuracy of 96.0%. CONCLUSIONS The urine-HpELISA is a rapid, inexpensive, reliable, and easy-to-perform method for the diagnosis of H pylori infection in children. It may be useful not only for diagnosis but also for mass screening for epidemiological studies in pediatric population.
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Affiliation(s)
- Masumi Okuda
- Department of Pediatrics, Wakayama Rosai Hospital, Nachi-Katsuura Hot-Spring Hospital, Wakayama, Japan.
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Shimizu T, Yarita Y, Haruna H, Kaneko K, Yamashiro Y, Gupta R, Anazawa A, Suzuki K. Urine-based enzyme-linked immunosorbent assay for the detection of Helicobacter pylori antibodies in children. J Paediatr Child Health 2003; 39:606-10. [PMID: 14629527 DOI: 10.1046/j.1440-1754.2003.00213.x] [Citation(s) in RCA: 17] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
OBJECTIVE Recent studies of urine-based enzyme-linked immunosorbent assays (ELISA) for detection of antibody to Helicobacter pylori (H. pylori) have already shown high sensitivity and specificity in adults. The diagnostic accuracy of these assays in children was investigated. METHODS The results of serum and urine-based ELISAs were compared with those of 13C-urea breath tests (13C-UBT) and/or detection of faecal H. pylori antigen in 68 children. The effect of urine total immunoglobulin G (IgG) levels on the ELISA results for anti-H. pylori antibodies in urine was also examined. RESULTS The sensitivity, specificity and accuracy of the serum ELISA were 72.7%, 96.3%, and 92.3% respectively, while those of the urine-based ELISA were 92.3%, 76.4%, and 79.4% respectively. The level of urine total IgG in children with false-positive results in the urine-based ELISA, was significantly higher than that in children who showed negative results in both the urine-based ELISA and the 13C-UBT and/or faecal H. pylori antigen tests. Human gamma-globulin affected the urine-based ELISA results at final concentrations of 2.0 mg/dL, 3.0 mg/dL, and 4.0 mg/dL; the anti-H. pylori antibody values were significantly higher than the ELISA values without the addition of human gamma-globulin. CONCLUSION The findings suggested that the specificity of urine-based ELISA for detection of H. pylori antibodies is low in children, since high urinary levels of total IgG increase the likelihood of false-positive results.
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Affiliation(s)
- T Shimizu
- Department of Pediatrics, Juntendo University School of Medicine and Tokyo Health Service Association, Tokyo, Japan.
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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.
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Affiliation(s)
- A Leodolter
- Department of Gastroenterology, Hepatology and Infectious Diseases, University of Magdeburg, Germany
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Solano-Gallego L, Rodríguez A, Iniesta L, Arboix M, Portús M, Alberola J. Detection of anti-Leishmania immunoglobulin G antibodies in urine specimens of dogs with leishmaniasis. CLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY 2003; 10:849-55. [PMID: 12965915 PMCID: PMC193878 DOI: 10.1128/cdli.10.5.849-855.2003] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
For years, anti-Leishmania immunoglobulin G (IgG) antibodies have been detected in the sera of dogs living in areas of leishmaniasis endemicity. They have also been found in the aqueous humor and cerebrospinal fluid. In contrast, a review of the literature failed to identify the detection of anti-Leishmania antibodies in urine samples from dogs with leishmaniasis. Ninety-five dog urine samples were examined for the presence of anti-Leishmania antibodies by using a protein A enzyme-linked immunosorbent assay (ELISA). Twenty additional urine samples were collected from healthy dogs as controls. An IgG2 ELISA was performed on 26 urine samples found positive by the protein A ELISA. Twenty-three urine samples found positive to anti-Leishmania antibodies were tested for the local production of anti-Leishmania antibodies in the urinary tract by means of the urine antibody coefficient. Ten urine samples (and the corresponding serum samples) were compared by Western blot (WB) analysis. Thirty-five out of the 95 urine samples were found positive, 57 were found negative, and 3 were found inconclusive for antibody detection by the protein A ELISA. A high correlation between protein A and IgG2 levels was found in positive urine samples. Anti-Leishmania antibodies were present in the urine of dogs that had leishmaniasis, urinary protein/creatinine (U P/C) ratios of greater than one, and normal urinary sediment. A statistically significant correlation was observed between the U P/C ratios and the levels of anti-Leishmania antibodies in positive urine samples. In general, WB analysis and the urine antibody coefficient suggested that the presence of anti-Leishmania antibodies in urine was the consequence of an impairment of filtration of the glomerular barrier. However, in some dogs, WB analysis could be interpreted as suggesting that the presence of anti-Leishmania antibodies was caused, to a lesser extent, by local antibody production in the urinary tract. Antibody detection in urine could be a noninvasive method for leishmaniasis diagnosis and prognosis in dogs with glomerulonephropathies.
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Affiliation(s)
- L Solano-Gallego
- Departament de Farmacologia, Terapèutica, i Toxicologia, Facultat de Veterinària, Universitat Autònoma de Barcelona, 08193 Bellaterra, Spain.
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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.
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Affiliation(s)
- S Kabir
- Academic Research and Information Management, Stockholm, Sweden.
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Yamamoto T, Tamura M, Ishii T, Anjiki H, Hattori K, Saitoh M, Sanaka M, Kuyama Y. Urinary antibody titers to Helicobacter pylori and an impact of clinical characteristics. J Clin Gastroenterol 2003; 36:329-31. [PMID: 12642740 DOI: 10.1097/00004836-200304000-00010] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
This study evaluates the clinical usefulness of titers of antibody to Helicobacter pylori (Hp) in a urine-based enzyme-linked immunosorbent assay (URINELISA; Otsuka Pharmaceutical, Tokushima, Japan) by comparing values of serum antibody to Hp in an already commercialized kit in a population of 250 asymptomatic individuals. Influences of physical and laboratory characteristics on the relationship between serum and urinary titers of antibody to Hp were also estimated using simple and multiple regression analyses. Specific urine gravity, urine pH, proteinuria, and age of the subjects were regarded as significant factors relating to urinary titers of the anti-Hp antibody on simple regression analyses. Both the urinary and serum titers strongly correlated on simple regression analysis (r = 0.782, P < 0.0001). On multiple regression analysis, an additional two factors, specific urine gravity and urine pH, were picked up, and the correlation coefficient was improved (r = 0.795, P < 0.0001). The present results indicate that URINELISA had not only qualitative but quantitative accuracy. However, careful attention should be paid to cases with abnormalities in urinalysis when used quantitatively.
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Affiliation(s)
- Takatsugu Yamamoto
- Department of Internal Medicine, Teikyo University School of Medicine, Japan.
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