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Ding SZ, Du YQ, Lu H, Wang WH, Cheng H, Chen SY, Chen MH, Chen WC, Chen Y, Fang JY, Gao HJ, Guo MZ, Han Y, Hou XH, Hu FL, Jiang B, Jiang HX, Lan CH, Li JN, Li Y, Li YQ, Liu J, Li YM, Lyu B, Lu YY, Miao YL, Nie YZ, Qian JM, Sheng JQ, Tang CW, Wang F, Wang HH, Wang JB, Wang JT, Wang JP, Wang XH, Wu KC, Xia XZ, Xie WF, Xie Y, Xu JM, Yang CQ, Yang GB, Yuan Y, Zeng ZR, Zhang BY, Zhang GY, Zhang GX, Zhang JZ, Zhang ZY, Zheng PY, Zhu Y, Zuo XL, Zhou LY, Lyu NH, Yang YS, Li ZS. Chinese Consensus Report on Family-Based Helicobacter pylori Infection Control and Management (2021 Edition). Gut 2022; 71:238-253. [PMID: 34836916 PMCID: PMC8762011 DOI: 10.1136/gutjnl-2021-325630] [Citation(s) in RCA: 107] [Impact Index Per Article: 35.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/12/2021] [Accepted: 11/03/2021] [Indexed: 02/05/2023]
Abstract
OBJECTIVE Helicobacter pylori infection is mostly a family-based infectious disease. To facilitate its prevention and management, a national consensus meeting was held to review current evidence and propose strategies for population-wide and family-based H. pylori infection control and management to reduce the related disease burden. METHODS Fifty-seven experts from 41 major universities and institutions in 20 provinces/regions of mainland China were invited to review evidence and modify statements using Delphi process and grading of recommendations assessment, development and evaluation system. The consensus level was defined as ≥80% for agreement on the proposed statements. RESULTS Experts discussed and modified the original 23 statements on family-based H. pylori infection transmission, control and management, and reached consensus on 16 statements. The final report consists of three parts: (1) H. pylori infection and transmission among family members, (2) prevention and management of H. pylori infection in children and elderly people within households, and (3) strategies for prevention and management of H. pylori infection for family members. In addition to the 'test-and-treat' and 'screen-and-treat' strategies, this consensus also introduced a novel third 'family-based H. pylori infection control and management' strategy to prevent its intrafamilial transmission and development of related diseases. CONCLUSION H. pylori is transmissible from person to person, and among family members. A family-based H. pylori prevention and eradication strategy would be a suitable approach to prevent its intra-familial transmission and related diseases. The notion and practice would be beneficial not only for Chinese residents but also valuable as a reference for other highly infected areas.
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Affiliation(s)
- Song-Ze Ding
- Department of Gastroenterology and Hepatology, People's Hospital, Zhengzhou University, Zhengzhou, Henan, China
- Department of Gastroenterology and Hepatology, People's Hospital, Henan University, Kaifeng, Henan, China
| | - Yi-Qi Du
- Gastroenterology Division, Changhai Hospital, Naval Medical University, Shanghai, China
| | - Hong Lu
- GI Division, Renji Hospital, Shanghai Institution of Digestive Diseas, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Wei-Hong Wang
- Department of Gastroenterology and Hepatology, Peking University First Hospital, Beijing, China
| | - Hong Cheng
- Department of Gastroenterology and Hepatology, Peking University First Hospital, Beijing, China
| | - Shi-Yao Chen
- Department of Gastroenterology and Hepatology, Zhongshan Hospital, Fudan University, Shanghai, China
| | - Min-Hu Chen
- Division of Gastroenterology and Hepatology, Sun Yat-Sen University First Affiliated Hospital, Guangzhou, Guangdong, China
| | - Wei-Chang Chen
- Department of Gastroenterology and Hepatology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
| | - Ye Chen
- Department of Gastroenterology and Hepatology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
| | - Jing-Yuan Fang
- Renji Hospital, Gastroenterology Division, Shanghai Jiao Tong University, Shanghai, China
| | - Heng-Jun Gao
- Department of Gastroenterology and Hepatology, School of Medicine, Tongji University, Shanghai, China
| | - Ming-Zhou Guo
- Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Beijing, China
| | - Ying Han
- Department of Gastroenterology and Hepatology, The Seventh Medical Center, Chinese PLA General Hospital, Beijing, China
| | - Xiao-Hua Hou
- Department of Gastroenterology and Hepatology, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China
| | - Fu-Lian Hu
- Department of Gastroenterology and Hepatology, Peking University First Hospital, Beijing, China
| | - Bo Jiang
- Department of Gastroenterology and Hepatology, Changgeng Hospital, Tsinghua University, Beijing, China
| | - Hai-Xing Jiang
- Department of Gastroenterology and Hepatology, First Affiliated Hospital, Guangxi Medical University, Nanning, Guangxi, China
| | - Chun-Hui Lan
- Department of Gastroenterology and Hepatology, Daping Hospital, Army Medical University, Chongqing, China
| | - Jing-Nan Li
- Department of Gastroenterology and Hepatology, Peking Union Medical College Hospital, Beijing, China
| | - Yan Li
- Department of Gastroenterology and Hepatology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
| | - Yan-Qing Li
- Department of Gastroenterology and Hepatology, Qilu Hospital, Shandong University, Jinan, Shandong, China
| | - Jie Liu
- Department of Gastroenterology and Hepatology, Huashan Hospital, Fudan University, Shanghai, China
| | - You-Ming Li
- Department of Gastroenterology and Hepatology, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
| | - Bin Lyu
- Department of Gastroenterology and Hepatology, First Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China
| | - You-Yong Lu
- Laboratory of Molecular Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital, Beijing, China
| | - Ying-Lei Miao
- Department of Gastroenterology and Hepatology, First Affilliated Hospital, Kunming Medical University, Kunming, Yunnan, China
| | - Yong-Zhan Nie
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital, Air Force Medical University, Xian, Shaanxi, China
| | - Jia-Ming Qian
- Department of Gastroenterology and Hepatology, Peking Union Medical College Hospital, Beijing, China
| | - Jian-Qiu Sheng
- Department of Gastroenterology, The Seventh Medical Center, Chinese PLA General Hospital, Beijing, China
| | - Cheng-Wei Tang
- Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China
| | - Fen Wang
- Department of Gastroenterology and Hepatology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China
- Hunan Key Laboratory of Nonresolving Inflammation and Cancer, Changsha, Hunan, China
| | - Hua-Hong Wang
- Department of Gastroenterology and Hepatology, Peking University First Hospital, Beijing, China
| | - Jiang-Bin Wang
- Department of Gastroenterology and Hepatology, China-Japan Union Hospital of Jilin University, Changchun, Jilin, China
| | - Jing-Tong Wang
- Department of Gastroenterology and Hepatology, Peking University Third Hospital, Beijing, China
| | - Jun-Ping Wang
- Department of Gastroenterology and Hepatology, First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China
| | - Xue-Hong Wang
- Department of Gastroenterology and Hepatology, Qinghai University Hospital, Qinghai University, Xining, Qinghai, China
| | - Kai-Chun Wu
- Department of Gastroenterology and Hepatology, Xijing Hospital, Air Force Medical University, Xian, Shaanxi, China
| | - Xing-Zhou Xia
- Department of Gastroenterology and Hepatology, The Fifth Affiliated Hospital, Zhengzhou University, Zhengzhou, Henan, China
| | - Wei-Fen Xie
- Department of Gastroenterology, Changzheng Hospital, Naval Medical University, Shanghai, China
| | - Yong Xie
- Department of Gastroenterology and Hepatology, First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
| | - Jian-Ming Xu
- Department of Gastroenterology and Hepatology, First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
| | - Chang-Qing Yang
- Division of Gastroenterology and Hepatology, Tongji Hospital, Tongji University, Shanghai, China
| | - Gui-Bin Yang
- Department of Gastroenterology and Hepatology, Aerospace Central Hospital, Beijing, China
| | - Yuan Yuan
- Key Laboratory of GI Cancer Etiology and Prevention in Liaoning Province, First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China
| | - Zhi-Rong Zeng
- Department of Gastroenterology and Hepatology, First Affiliated Hospital, Zhongshan University, Guangzhou, Guangdong, China
| | - Bing-Yong Zhang
- Department of Gastroenterology and Hepatology, People's Hospital, Zhengzhou University, Zhengzhou, Henan, China
| | - Gui-Ying Zhang
- Department of Gastroenterology and Hepatology, Xiangya Hospital, Central South University, Changsha, Hunan, China
| | - Guo-Xin Zhang
- Department of Gastroenterology and Hepatology, First Affiliated Hospital, Nanjing Medical University, Nanjing, Jiangsu, China
| | - Jian-Zhong Zhang
- Department of Communicable Disease Diagnostics(DCDD), National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| | - Zhen-Yu Zhang
- Department of Gastroenterology and Hepatology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China
| | - Peng-Yuan Zheng
- Department of Gastroenterology and Hepatology, The Fifth Affiliated Hospital, Zhengzhou University, Zhengzhou, Henan, China
| | - Yin Zhu
- Department of Gastroenterology, First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, China
| | - Xiu-Li Zuo
- Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China
| | - Li-Ya Zhou
- Department of Gastroenterology and Hepatology, Peking University Third Hospital, Beijing, China
| | - Nong-Hua Lyu
- Department of Gastroenterology and Hepatology, First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
| | - Yun-Sheng Yang
- Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Beijing, China
| | - Zhao-Shen Li
- Department of Gastroenterology and Hepatology, Changhai Hospital, Naval Medical University, Shanghai, China
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Tshibangu-Kabamba E, Phuc BH, Tuan VP, Fauzia KA, Kabongo-Tshibaka A, Kayiba NK, Rosas-Aguirre A, Devleesschauwer B, Cimuanga-Mukanya A, Ngoma Kisoko PDJ, Matsumoto T, Akada J, Disashi GT, Mumba Ngoyi D, Kido Y, Speybroeck N, Yamaoka Y. Assessment of the diagnostic accuracy and relevance of a novel ELISA system developed for seroepidemiologic surveys of Helicobacter pylori infection in African settings. PLoS Negl Trop Dis 2021; 15:e0009763. [PMID: 34499649 PMCID: PMC8455143 DOI: 10.1371/journal.pntd.0009763] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/26/2020] [Revised: 09/21/2021] [Accepted: 08/25/2021] [Indexed: 01/18/2023] Open
Abstract
Beside diagnostic uncertainties due to the lack of a perfect gold standard test for Helicobacter pylori infection, the diagnosis and the prevalence estimation for this infection encounter particular challenges in Africa including limited diagnostic tools and specific genetic background. We developed and evaluated the accuracy of an enzyme-linked immunosorbent assay (ELISA) system tailored for H. pylori genetics in Africa (HpAfr-ELISA). Strains belonging to main genetic populations infecting Africans were exploited as sources for whole-cell antigens to establish in-house the ELISA system. A phase II unmatched case-control study explored the diagnostic accuracy of the HpAfr-ELISA using a training set of samples collected from dyspeptic patients from Kinshasa, the Democratic Republic of Congo (DRC) who had been tested with invasive standard tests (i.e., histology, culture, and rapid urease test) in 2017. Then the assay was cross-validated through a community-based survey assessing the prevalence of H. pylori and associated factors in 425 adults from Mbujimayi, DRC in 2018. Bayesian inferences were used to deal with statistical uncertainties of estimates (true prevalence, sensitivity, and specificity) in the study population. At its optimal cut-off-value 20.2 U/mL, the assay achieved an estimated sensitivity of 97.6% (95% credible interval [95%CrI]: 89.2; 99.9%) and specificity of 90.5% (95%CrI: 78.6; 98.5). Consistent outcomes obtained at repeated tests attested the robustness of the assay (negative and positive agreements always > 70%). The true prevalence of H. pylori was estimated 53.8% [95%CrI: 42.8; 62.7%]. Increasing age (adjusted odds ratio [aOR] > 1.0 [95% confidence interval (CI): > 1.0; 1.1]; p<0.001), overcrowding households (aOR = 3.2 [95%CI: 2.0; 5.1]; p<0.001), and non-optimal hand hygiene (aOR = 4.5 [95%CI: 2.0; 11.4]; p = 0.001) were independently associated with the H. pylori-seropositivity. The novel ELISA system has demonstrated good diagnostic accuracy and potential usefulness for management and mitigation strategies for H. pylori infection in African settings.
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Affiliation(s)
- Evariste Tshibangu-Kabamba
- Department of Environmental and Preventive Medicine, Faculty of Medicine, Oita University, Oita, Japan
- Department of Internal Medicine, Faculty of Medicine, University of Mbujimayi, Mbujimayi, DR Congo
- Research Center for Infectious Diseases Sciences & Department of Parasitology, Graduate School of Medicine, Osaka City University, Osaka, Japan
| | - Bui Hoang Phuc
- Department of Environmental and Preventive Medicine, Faculty of Medicine, Oita University, Oita, Japan
| | - Vo Phuoc Tuan
- Department of Environmental and Preventive Medicine, Faculty of Medicine, Oita University, Oita, Japan
- Department of Endoscopy, Cho Ray Hospital, Cho Ray, Vietnam
| | - Kartika Afrida Fauzia
- Department of Environmental and Preventive Medicine, Faculty of Medicine, Oita University, Oita, Japan
- Institute of Tropical Disease, Universitas Airlangga, Surabaya, Indonesia
- Department of Public Health and Preventive Medicine, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
| | | | - Nadine Kalenda Kayiba
- Research Institute of Health and Society (IRSS), Université catholoique de Louvain, Brussels, Belgium
- Department of Public Health, Faculty of Medicine, University of Mbujimayi, Mbujimayi, DR Congo
| | - Angel Rosas-Aguirre
- Research Institute of Health and Society (IRSS), Université catholoique de Louvain, Brussels, Belgium
| | - Brecht Devleesschauwer
- Department of Epidemiology and Public Health, Sciensano, Brussels, Belgium
- Department of Veterinary Public Health and Food Safety, Ghent University, Merelbeke, Belgium
| | - Alain Cimuanga-Mukanya
- Department of Environmental and Preventive Medicine, Faculty of Medicine, Oita University, Oita, Japan
- Department of Internal Medicine, Faculty of Medicine, University of Mbujimayi, Mbujimayi, DR Congo
| | - Patrick de Jésus Ngoma Kisoko
- Department of Gastroenterology and Hepatology, Faculty of Medicine, University of Kinshasa, Kinshasa, DR Congo
- Department of Gastroenterology and Hepatology, General Referential Hospital of Bukavu, Bukavu, DR Congo
| | - Takashi Matsumoto
- Department of Environmental and Preventive Medicine, Faculty of Medicine, Oita University, Oita, Japan
| | - Junko Akada
- Department of Environmental and Preventive Medicine, Faculty of Medicine, Oita University, Oita, Japan
| | - Ghislain Tumba Disashi
- Department of Internal Medicine, Faculty of Medicine, University of Mbujimayi, Mbujimayi, DR Congo
| | - Dieudonné Mumba Ngoyi
- Department of Parasitology, National Institute of Biomedical Research, Kinshasa, DR Congo
| | - Yasutoshi Kido
- Department of Environmental and Preventive Medicine, Faculty of Medicine, Oita University, Oita, Japan
- Research Center for Infectious Diseases Sciences & Department of Parasitology, Graduate School of Medicine, Osaka City University, Osaka, Japan
| | - Niko Speybroeck
- Research Institute of Health and Society (IRSS), Université catholoique de Louvain, Brussels, Belgium
| | - Yoshio Yamaoka
- Department of Environmental and Preventive Medicine, Faculty of Medicine, Oita University, Oita, Japan
- Department of Medicine, Gastroenterology section, Baylor College of Medicine, Houston, Texas, United States of America
- Global Oita Medical Advanced Research Center for Health, Oita University, Yufu, Japan
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Miftahussurur M. Noninvasive Helicobacter pylori Diagnostic Methods in Indonesia. Gut Liver 2020; 14:553-559. [PMID: 31693853 PMCID: PMC7492493 DOI: 10.5009/gnl19264] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2019] [Revised: 10/04/2019] [Accepted: 10/06/2019] [Indexed: 12/13/2022] Open
Abstract
Although the prevalence of Helicobacter pylori infection in Indonesia is lower than that in other countries, H. pylori is still an essential pathogen associated with severe gastric mucosal damage and dyspeptic symptoms. Invasive diagnostic methods are not ideal due to the lack of endoscopic centers and high costs without full coverage by social insurance. Among the noninvasive methods, the urea breath test is widely available in Indonesia and has been suggested as the primary option to ensure the successful eradication of H. pylori. There has been no local validation for the urea breath test utilizing 13C or 14C. The stool antigen test is inexpensive and suitable for use in active infections before and after eradication; however, customs and habits are obstacles to delivering fresh stool on time. Only polyclonal antibodies and qualitative stool antigen test kits with low sensitivity are available. Serology is a widely validated method and has good accuracy, but it cannot distinguish between active and inactive infections. According to our observations, serology is the main choice of experts and patients, as it is simple, inexpensive and widely known. The urine test is an alternative for reducing costs and endoscopic workload, with high accuracy but low sensitivity. Further studies are necessary to prove the validity of the urine test to be used throughout Indonesia, especially in areas with a low prevalence of H. pylori infection. In conclusion, the validated urea breath test and the stool antigen test are considered noninvasive practical approaches for the detection of H. pylori infection in Indonesia, with serological and urine tests as alternatives.
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Affiliation(s)
- Muhammad Miftahussurur
- Division of Gastroentero-Hepatology, Department of Internal Medicine, Faculty of Medicine Universitas Airlangga, Surabaya, Indonesia.,Institute of Tropical Disease, Universitas Airlangga, Surabaya, Indonesia
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Ogata SK, Camorlinga-Ponce M, Granato CFH, Rohr MRDS, Artigiani R, Kawakami E. Development and validation of a whole-cell ELISA for serologically diagnosing Helicobacter pylori infection in Brazilian children and adults: a diagnostic accuracy study. SAO PAULO MED J 2018; 136:442-448. [PMID: 30570095 PMCID: PMC9907764 DOI: 10.1590/1516-3180.2018.0203310818] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/12/2018] [Revised: 05/21/2018] [Accepted: 08/31/2018] [Indexed: 01/10/2023] Open
Abstract
BACKGROUND Serological tests are practical, with low cost, but no noninvasive tests are available for diagnosing Helicobacter pylori (H. pylori) infection in Brazil. The aim here was to develop and validate enzyme-linked immunosorbent assay (ELISA) serological tests to detect anti-H. pylori immunoglobulin G antibodies, based on cultured strains from Brazilian patients. DESIGN AND SETTING Cross-sectional, diagnostic accuracy study comparing a locally developed and validated ELISA and invasive tests among dyspeptic patients at two public hospitals in São Paulo, Brazil. METHODS An ELISA test was prepared using whole-cell antigen from 56 strains. After genotypic characterization, it was standardized and optical density (OD) cutoffs were determined based on the serum antibody response of 100 H. pylori-negative samples, compared with 82 H. pylori-positive samples. Validation was performed on 174 symptomatic patients. RESULTS The optimal OD cutoffs established (for monoclonal and polyclonal tests, respectively) were 0.167 and 0.164; overall ELISA sensitivity: 84.3%, 78.9%; specificity: 88.6%, 90.6%; positive predictive value (PPV): 75.4%, 80%; negative predictive value (NPV): 93.1%, 81.8%; accuracy: 87.3%, 86.2%; child and adolescent ELISA sensitivity: 74.2%, 81.8%; specificity: 90.8%, 86.7%; PPV: 66.6%, 84.3%; NPV: 95.8%, 84.8%; accuracy: 88.5%, 84.6; adult ELISA sensitivity: 84.4%, 75%; specificity: 86.9%, 93%; PPV: 81.8%, 78.3%; NPV: 88.9%, 91.8%; accuracy: 85.9%, 88.5%. CONCLUSION The polyclonal serological test developed using local strains presented better diagnostic performance among children and adolescents, while the monoclonal test was better among adults. The results from both tests suggest that these in-house serological tests could be used to detect anti-H. pylori antibodies in our population, for screening purposes.
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Affiliation(s)
- Silvio Kazuo Ogata
- MD, PhD. Clinical Instructor, Discipline of Pediatric Gastroenterology, Department of Pediatrics, Escola Paulista de Medicina, Universidade Federal de São Paulo (EPM-UNIFESP), São Paulo (SP), Brazil.
| | - Margarita Camorlinga-Ponce
- MBD. Senior Researcher, Infectious Disease Research Unit, UMAE Hospital de Pediatria, Instituto Mexicano del Seguro Social, Mexico City (DF), Mexico.
| | - Celso Francisco Hernandes Granato
- MD, PhD. Associate Professor, Discipline of Parasitic and Infectious Diseases, Department of Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo (EPM-UNIFESP), São Paulo (SP), Brazil.
| | - Maria Rachel da Silveira Rohr
- MD, PhD. Clinical Instructor, Discipline of Gastroenterology, Department of Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo (EPM-UNIFESP), São Paulo (SP), Brazil.
| | - Ricardo Artigiani
- MD, PhD. Full Professor, Discipline of Clinical Pathology, Department of Pathology, Escola Paulista de Medicina, Universidade Federal de São Paulo (EPM-UNIFESP), São Paulo (SP), Brazil.
| | - Elisabete Kawakami
- MD, PhD. Full Professor, Discipline of Pediatric Gastroenterology, Department of Pediatrics, Escola Paulista de Medicina, Universidade Federal de São Paulo (EPM-UNIFESP), São Paulo (SP), Brazil.
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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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Khalilpour A, Kazemzadeh-Narbat M, Tamayol A, Oklu R, Khademhosseini A. Biomarkers and diagnostic tools for detection of Helicobacter pylori. Appl Microbiol Biotechnol 2016; 100:4723-34. [PMID: 27084783 DOI: 10.1007/s00253-016-7495-7] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/18/2016] [Revised: 03/21/2016] [Accepted: 03/22/2016] [Indexed: 12/13/2022]
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Diagnostic Methods of Helicobacter pylori Infection for Epidemiological Studies: Critical Importance of Indirect Test Validation. BIOMED RESEARCH INTERNATIONAL 2016; 2016:4819423. [PMID: 26904678 PMCID: PMC4745376 DOI: 10.1155/2016/4819423] [Citation(s) in RCA: 77] [Impact Index Per Article: 8.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 10/02/2015] [Accepted: 12/16/2015] [Indexed: 01/06/2023]
Abstract
Among the methods developed to detect H. pylori infection, determining the gold standard remains debatable, especially for epidemiological studies. Due to the decreasing sensitivity of direct diagnostic tests (histopathology and/or immunohistochemistry [IHC], rapid urease test [RUT], and culture), several indirect tests, including antibody-based tests (serology and urine test), urea breath test (UBT), and stool antigen test (SAT) have been developed to diagnose H. pylori infection. Among the indirect tests, UBT and SAT became the best methods to determine active infection. While antibody-based tests, especially serology, are widely available and relatively sensitive, their specificity is low. Guidelines indicated that no single test can be considered as the gold standard for the diagnosis of H. pylori infection and that one should consider the method's advantages and disadvantages. Based on four epidemiological studies, culture and RUT present a sensitivity of 74.2–90.8% and 83.3–86.9% and a specificity of 97.7–98.8% and 95.1–97.2%, respectively, when using IHC as a gold standard. The sensitivity of serology is quite high, but that of the urine test was lower compared with that of the other methods. Thus, indirect test validation is important although some commercial kits propose universal cut-off values.
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Lee SY, Moon HW, Hur M, Yun YM. Validation of western Helicobacter pylori IgG antibody assays in Korean adults. J Med Microbiol 2015; 64:513-518. [PMID: 25752852 DOI: 10.1099/jmm.0.000050] [Citation(s) in RCA: 28] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/05/2014] [Accepted: 03/04/2015] [Indexed: 12/14/2022] Open
Abstract
Helicobacter pylori infection is endemic in Korea, and serology testing is widely performed. The aim of this study was to validate and compare the diagnostic accuracy of Korean and Western serological assays for H. pylori detection in Korean adults. The 114 Korean adults who visited our centre over a 6-month period for the evaluation of H. pylori infection using the urea breath test (UBT) were enrolled in this prospective study. Anti-H. pylori IgG was measured using three commercially available immunoassays: Genedia H. pylori ELISA (Green Cross Medical Science), Chorus helicobacter IgG (DIESSE Diagnostica Senese) and Vidas H. pylori IgG (bioMérieux). Positive UBT findings were obtained in 40.6% of included subjects. The sensitivities and the specificities of Vidas, Chorus and Genedia were 89.7%, 100% and 100% and 85.5%, 75.4% and 80.7%, respectively. We found no differences in sensitivity between the Vidas and Chorus (P=0.125), Chorus and Genedia (P=0.125) and Vidas and Genedia (P=1.000) assays. There were also no differences in specificity between the Vidas and Chorus (P=0.070), Chorus and Genedia (P=0.508) and Vidas and Genedia (P=0.549) assays. In Korean adults, the Genedia H. pylori ELISA, Chorus helicobacter IgG and Vidas H. pylori IgG assays exhibited a high concurrence rate with similar diagnostic accuracy. Thus, both the Korean and Western non-invasive assays are reliable for serodiagnosis of H. pylori in Korean individuals.
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Affiliation(s)
- Sun-Young Lee
- Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea
| | - Hee-Won Moon
- Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea
| | - Mina Hur
- Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea
| | - Yeo-Min Yun
- Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea
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Khalilpour A, Santhanam A, Wei LC, Saadatnia G, Velusamy N, Osman S, Mohamad AM, Noordin R. Antigenic proteins of Helicobacter pylori of potential diagnostic value. Asian Pac J Cancer Prev 2014; 14:1635-42. [PMID: 23679248 DOI: 10.7314/apjcp.2013.14.3.1635] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/10/2022] Open
Abstract
Helicobacter pylori antigen was prepared from an isolate from a patient with a duodenal ulcer. Serum samples were obtained from culture-positive H. pylori infected patients with duodenal ulcers, gastric ulcers and gastritis (n=30). As controls, three kinds of sera without detectable H. pylori IgG antibodies were used: 30 from healthy individuals without history of gastric disorders, 30 from patients who were seen in the endoscopy clinic but were H. pylori culture negative and 30 from people with other diseases. OFF-GEL electrophoresis, SDS-PAGE and Western blots of individual serum samples were used to identify protein bands with good sensitivity and specificity when probed with the above sera and HRP-conjugated anti-human IgG. Four H. pylori protein bands showed good (≥ 70%) sensitivity and high specificity (98-100%) towards anti-Helicobacter IgG antibody in culture- positive patients sera and control sera, respectively. The identities of the antigenic proteins were elucidated by mass spectrometry. The relative molecular weights and the identities of the proteins, based on MALDI TOF/ TOF, were as follows: CagI (25 kDa), urease G accessory protein (25 kDa), UreB (63 kDa) and proline/pyrroline- 5-carboxylate dehydrogenase (118 KDa). These identified proteins, singly and/or in combinations, may be useful for diagnosis of H. pylori infection in patients.
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Affiliation(s)
- Akbar Khalilpour
- Institute for Research in Molecular Medicine, Universiti Sains Malaysia, Minden, Malaysia
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10
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Aziz F, Sherwani SK, Akhtar SS, Kazmi SU. Development of an in-house enzyme-linked immunosorbent assay based on surface whole cell antigen for diagnosis of Helicobacter pylori infection in patients with gastroduodenal ulcer disease. World J Microbiol Biotechnol 2014; 30:305-15. [PMID: 23921679 DOI: 10.1007/s11274-013-1448-4] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/05/2013] [Accepted: 07/25/2013] [Indexed: 01/01/2023]
Abstract
Helicobacter pylori (H. pylori) is a causative agent of gastritis, gastroduodenal ulcers and gastric adenocarcinoma. More than 50% world population is colonized by H. pylori, which is closely related to the chronic gastritis and gastric ulcer infection. In this study, a total of 214 gastritis patient's serum samples were screened for anti-H. pylori IgG antibody. A 96-well plate coated with 20 μg/ml antigen and hundred-fold diluted patient's serum was allowed to react. After extensive washing with buffer, 1:2,500 diluted conjugated secondary antibody was added. Later substrate was added to observe positivity by measuring the intensity of color. Statistical analyses were performed, and p value of <0.01 was taken as significant; 84% male patients and 89% female patients, respectively, tested positive for H. pylori, while agewise distribution was 35-45 years males (40%) and 35-55 years females (52%) were found highest number of H. pylori infected patients. In-house ELISA based on surface whole cell antigen (wELISA) showed a sensitivity of 93%, specificity of 100%, accuracy 94% and κ value 0.86 with significant correlation R-0.77020; p < 0.0001. We conclude that H. pylori local isolates surface antigen was satisfactory for diagnosis as different parameters were adjusted according to the local H. pylori isolates. Fluctuations in serum antibody titer predict the variation in an individual's response of the host against H. pylori. In-house wELISA could provide a reliable and a clinically useful method for the diagnosis of H. pylori infection in patients of Karachi, Pakistan.
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Affiliation(s)
- Faisal Aziz
- Immunology and Infectious Diseases Research Laboratory (IIDRL), Department of Microbiology, University of Karachi, Karachi, 75270, Pakistan,
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11
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Yamada K, Sugiyama T, Mihara H, Kajiura S, Saito S, Itaya Y, Yamawaki H, Ando T, Kudo T, Hosokawa A, Okuda M, Fukunaga K, Akada JK, Nakazawa T. Fragmented CagA protein is highly immunoreactive in Japanese patients. Helicobacter 2012; 17:187-92. [PMID: 22515356 DOI: 10.1111/j.1523-5378.2011.00930.x] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/09/2022]
Abstract
BACKGROUND High-molecular-weight cell-associated proteins (HM-CAP) assay is the most popular serological immunoassay worldwide and has been developed from US isolates as the antigens. The accuracy is reduced when the sera are from adults and children in East Asia including Japan. To overcome the reduced accuracy, an enzyme immunoassay using Japanese strain-derived HM-CAP (JHM-CAP) was developed, in which the antigens were prepared by exactly the same procedure as HM-CAP. The performance of JHM-CAP was better than that of HM-CAP in Japanese adults as well as in children. The higher sensitivity was because of the presence of 100-kDa protein that was absent in the preparation of HM-CAP antigen. MATERIALS AND METHODS Immunoblot analysis and peptide mass fingerprinting methods were used to identify the distinctive 100-kDa protein present in JHM-CAP antigens. The peptide sequence and identification were analyzed by Mascot Search on the database of Helicobacter pylori. The identified protein was confirmed by immunoblot with a specific antibody and inhibition assay by the sera. RESULTS The distinctive 100-kDa protein was a fragment of CagA derived from Japanese clinical isolates, and the sera of Japanese patients had strongly reacted to the protein, probably to the exposed epitope on the fragmented CagA. The fragmentation of CagA had occurred in the process of antigen preparation in Japanese isolates, not in US isolates even under the same preparation. CONCLUSION The distinctive 100-kDa protein was a fragment of CagA protein of H. pylori derived from Japanese clinical isolates, and Japanese patients including children are likely to react strongly to the exposed epitopes on fragmented CagA.
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Affiliation(s)
- Kazuki Yamada
- Department of Gastroenterology, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan
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12
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Gong YH, Sun LP, Jin SG, Yuan Y. Comparative study of serology and histology based detection of Helicobacter pylori infections: a large population-based study of 7,241 subjects from China. Eur J Clin Microbiol Infect Dis 2010; 29:907-11. [PMID: 20440530 DOI: 10.1007/s10096-010-0944-9] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/23/2009] [Accepted: 04/08/2010] [Indexed: 12/13/2022]
Abstract
Two detection methods for H. pylori infections, i.e. serological antibody titer measurements by Hp-ELISA and histological scoring by HE staining, have been compared to investigate the relationship between the diagnosis methods, to clarify the application scope of each diagnosis method and to determine its influencing factors. In the 7,241 subjects who participated in gastric cancer screening, H. pylori infection rate was 70.14% by the Hp-HE method and 41.87% by the Hp-ELISA method when 34EIU was recognized as the cut-off value. The IgG titers increased with the elevation of HE scores; however, the two methods were not closely correlated among those in different gastric disease status. Age, gender and drinking status did not have significant impact on the relationship between the two methods; however, smoking status seemed to significantly influence the correlation of the two diagnosis methods. In conclusion, it was necessary to reevaluate the cut-off value when using ELISA test kits in different population groups. In most cases, the results of two H. pylori infection diagnosis methods show high correlation. However, this relationship can be affected by smoking and gastric diseases status. Additionally, the dynamic change of H. pylori antibody titers is an indicator of gastric disease development.
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Affiliation(s)
- Y H Gong
- Cancer Control Laboratory of Cancer Institute and General Surgery, The First Affiliated Hospital of China Medical University, the Key Laboratory of Cancer Control in Liaoning Province, Shenyang 110001, China
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13
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Sasidharan S, Uyub AM. Prevalence of Helicobacter pylori infection among asymptomatic healthy blood donors in Northern Peninsular Malaysia. Trans R Soc Trop Med Hyg 2009; 103:395-8. [PMID: 19211121 DOI: 10.1016/j.trstmh.2008.11.021] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/16/2008] [Revised: 11/22/2008] [Accepted: 11/22/2008] [Indexed: 01/30/2023] Open
Abstract
Helicobacter pylori infection is recognized as being strongly associated with chronic gastritis, duodenal ulceration and, probably, gastric carcinoma. Seroepidemiological studies have shown that a large proportion of healthy people have antibodies against H. pylori. A serological study was conducted in asymptomatic healthy blood donors in Northern Peninsular Malaysia to assess the seropositivity for H. pylori and to investigate the relationship with ethnic group, gender, ABO blood group and age. A total of 5370 serum samples collected from 3677 male and 1693 female donors in different age groups, and who had no gastrointestinal complaints, were studied with an in-house ELISA for the presence of H. pylori IgG and IgA antibodies. Seven hundred and sixty subjects (14.2%) were seropositive. The overall seropositivity did not differ with ethnicity, gender, ABO blood group and age among asymptomatic healthy blood donors in Northern Peninsular Malaysia.
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Affiliation(s)
- S Sasidharan
- School of Biological Sciences, University of Science, Malaysia, 11800 Minden, Pulau Pinang, Malaysia.
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14
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ADVANTAGE OF USING A HOME-MADE ELISA KIT FOR DETECTION OF HELICOBACTER PYLORI INFECTION OVER COMMERCIALLY IMPORTED KITS. Indian J Med Microbiol 2008. [DOI: 10.1016/s0255-0857(21)01927-7] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
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15
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Yang KC, Chu A, Liao CS, Lin YM, Wang GM. Evaluation of the role of H pylori infection in pathogenesis of gastric cancer by immunoblot assay. World J Gastroenterol 2006; 12:7029-32. [PMID: 17109500 PMCID: PMC4087349 DOI: 10.3748/wjg.v12.i43.7029] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.5] [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: To elucidate the different serological reactions to H pylori using the immunoblotting technique for further understanding of its pathogenic role in gastric cancer.
METHODS: A total of 54 patients were divided into two groups after upper gastrointestinal endoscopy: normal control group (25 patients) and gastric cancer group (29 patients). Both groups were further divided into H pylori (+) and H pylori (-) subgroups based on the results of CLO test, Giemsa staining and culture. Sera were further analyzed with the immunoblotting technique (HelicoBlot 2.0, Genelabs Diagnostics, Singapore).
RESULTS: The positive rate of the immunoblotting test was as high as 88.9% in the H pylori (-) gastric cancer group and only 14.3% in the H pylori (-) normal control group with a statistically significant difference.
CONCLUSION: The prevalence of H pylori infection is higher in gastric cancer patients than in the normal controls, suggesting that H pylori may play a role in the pathogenesis of gastric cancer.
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Affiliation(s)
- Kuo-Ching Yang
- Division of Gastroenterology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan, China
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16
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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.
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Affiliation(s)
- Chien-Yu Lu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung City 807, Taiwan
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17
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Hoang TTH, Rehnberg AS, Wheeldon TU, Bengtsson C, Phung DC, Befrits R, Sörberg M, Granström M. Comparison of the performance of serological kits for Helicobacter pylori infection with European and Asian study populations. Clin Microbiol Infect 2006; 12:1112-7. [PMID: 17002611 DOI: 10.1111/j.1469-0691.2006.01514.x] [Citation(s) in RCA: 14] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/28/2022]
Abstract
Most commercial kits for the detection of Helicobacter pylori were developed and validated with Western populations, and some have been found to perform less well with Asian populations. This study compared the performances of three serological kits with Swedish and Vietnamese peptic ulcer patients and asymptomatic individuals. The Pyloriset EIA-GIII and HM-CAP ELISA kits indicated that Asian populations had lower antibody titres to H. pylori than European populations. Despite the difference, the Pyloriset EIA-GIII kit performed well with Vietnamese peptic ulcer patients and population controls. The HM-CAP ELISA kit had a significantly lower performance with Asian populations that could not be improved by adjustments to the cut-off level. The Helicoblot 2.1 immunoblot kit performed equally well with Vietnamese and Swedish populations, although the response rate to the 35-kDa band was significantly lower with Vietnamese individuals.
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Affiliation(s)
- T T H Hoang
- Department of Clinical Microbiology, Microbiology and Tumour Biology Centre, Karolinska University Hospital, Stockholm, Sweden
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18
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Okuda M, Sugiyama T, Fukunaga K, Kondou M, Miyashiro E, Nakazawa T. A strain-specific antigen in Japanese Helicobacter pylori recognized in sera of Japanese children. CLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY 2006; 12:1280-4. [PMID: 16275941 PMCID: PMC1287759 DOI: 10.1128/cdli.12.11.1280-1284.2005] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Subscribe] [Scholar Register] [Indexed: 01/10/2023]
Abstract
An enzyme immuno assay (EIA) test based on Japanese strain-derived high-molecular-weight cell-associated proteins (JHM-CAP) was evaluated by comparing with a previously developed EIA test based on a U.S. strain-derived high-molecular-weight cell-associated proteins (HM-CAP). Serum samples of 131 Japanese asymptomatic children (mean age, 5.5 years; range, 0 to 21 years) were tested that include 43 positive and 88 negative children as judged by Helicobacter pylori stool antigen test (HpSA test). Both tests showed comparable and reliable specificities, but the sensitivity of JHM-CAP EIA, at 93.0%, was much higher than that of HM-CAP EIA, at 67.4%. More false-negative results of HM-CAP were obtained in children under 10 years of age. Immunoblot analysis revealed that the JHM-CAP but not the HM-CAP preparation had a 100-kDa antigen recognized by JHM-CAP positive sera. It was concluded that JHM-CAP EIA is highly accurate for the serodiagnosis of H. pylori infection in Japanese young children and that the high sensitivity of JHM-CAP EIA in contrast to HM-CAP EIA is due to the presence of a 100-kDa antigen in Japanese strains that may be recognized by the host immune system at an early stage of infection.
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Affiliation(s)
- Masumi Okuda
- Department of Pediatrics, Wakayama Rosai Hospital, Koya 435, Wakayama, 640-8505, Japan.
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Treepongkaruna S, Nopchinda S, Taweewongsounton A, Atisook K, Pienvichit P, Vithayasai N, Simakachorn N, Aanpreung P. A rapid serologic test and immunoblotting for the detection of Helicobacter pylori infection in children. J Trop Pediatr 2006; 52:267-71. [PMID: 16401613 DOI: 10.1093/tropej/fmk003] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
The gold standard for the diagnosis of Helicobacter pylori infection requires an endoscopic biopsy of gastric mucosa for histological examination, urease test and culture. Noninvasive serological tests are useful as a screening test for H. pylori infection. The aim of this study was to evaluate the performance of a rapid office-based serologic test, using immunochromatography ICM, and the immunoblotting for the diagnosis of H. pylori infection in Thai children. Eighty-two symptomatic children, 30 boys and 52 girls (mean age 9.2+/-3.8 years; range, 1.2-16.0 years) who had no previous treatment for H. pylori underwent upper endoscopy. Biopsies were obtained from the gastric body and antrum for histopathology and rapid urease test. Serum samples collected from all patients were tested for H. pylori IgG antibodies using ICM (Assure H. pylori Rapid Test, Genelabs Diagnostics, Singapore). Immunoblotting (HelicoBlot 2.1, Genelabs Diagnostics, Singapore) was tested in sera of 75 patients to detect antibodies to specific antigens of H. pylori. Positive H. pylori status was defined as positive for both histology and rapid urease test. Of 82 patients, 25 (30.5%) were H. pylori positive, 56 (68.3%) were H. pylori negative and one was equivocal. ICM assay yielded a positive result in 24 of the 25 H. pylori-positive patients (96.0%) and 3 of the 56 H. pylori-negative patients (5.4%). The immunoblotting yielded a positive result in all of 22 H. pylori-positive patients (100%) and in 2 of the 52 H. pylori-negative patients (3.8%). Obtained ICM's sensitivity, specificity, positive predictive value, negative predictive value and accuracy were 96.0, 94.6, 88.9, 98.1 and 95.1%, with immunoblotting 100.0, 96.2, 91.6, 100.0, and 97.3%, respectively. The immunochromatographic and immunoblot tests are non-invasive, reliable and useful for the diagnosis of H. pylori infection in Thai children.
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Affiliation(s)
- Suporn Treepongkaruna
- Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
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20
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Leung WK, Ng EKW, Lam CCH, Chan KF, Chan WY, Auyeung ACM, Wu JCY, Ching JYL, Lau JYW, Sung JJY. Helicobacter pylori infection in 1st degree relatives of Chinese gastric cancer patients. Scand J Gastroenterol 2006; 41:274-9. [PMID: 16497613 DOI: 10.1080/00365520510024269] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
OBJECTIVE Familial aggregation of gastric cancer has been linked to familial clustering of Helicobacter pylori infection. Patterns and risk factors associated with H. pylori infection were investigated in 1st degree relatives of Chinese gastric cancer patients. MATERIAL AND METHODS Gastric cancer relatives were invited for screening endoscopy. H. pylori infection was diagnosed by endoscopic and serological methods. RESULTS Among the 270 cancer relatives examined, 161 (59.6%) were found to be infected with H. pylori. The prevalence of infection in cancer relatives was significantly higher than age- and gender-matched dyspeptic control (45.5%, p=0.0006). The mean age of H. pylori-infected relatives was significantly older than that of non-infected relatives (43.9 versus 38.3 years; p<0.001). The prevalence of H. pylori infection was higher in those with more siblings (p=0.013, chi(2) test for trend). Moreover, individuals whose siblings had stomach cancer were more likely to have H. pylori infection than those with a parental history of cancer (68.2% versus 51.8%, p=0.007). In contrast, the youngest sibling had a significantly lower H. pylori infection rate than other siblings (39.2% versus 64.2%, p=0.001). Using multiple logistic regression, it was found that age >45 years (OR=1.8; 95% CI, 1.02-3.3) and a history of gastric cancer in siblings (OR=1.9; 95% CI, 1.06-3.3) were independent risk factors for H. pylori infection, and that the youngest sibling in the family had a reduced risk (OR=0.45; 95% CI, 0.24-0.84). CONCLUSIONS This study identifies the patterns and risk factors for H. pylori in gastric cancer relatives, which may shed light on the evolving epidemiology of H. pylori infection in Chinese patients.
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Affiliation(s)
- Wai K Leung
- Institute of Digestive Diseases, Shatin, Hong Kong.
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Mumtaz K, Abid S, Yakoob J, Abbas Z, Hamid S, Islam M, Shah HA, Jafri W. An office-based serological test for detection of current Helicobacter pylori infection: is it useful? Eur J Gastroenterol Hepatol 2006; 18:85-88. [PMID: 16357625 DOI: 10.1097/00042737-200601000-00015] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/10/2022]
Abstract
OBJECTIVE To compare the accuracy of a new office-based serological test for the detection of current Helicobacter pylori infection with gastric histopathology. METHODS An office-based serological test for detection of current H. pylori infection was performed in 92 consecutive patients with dyspeptic symptoms. The result of this test was compared blindly with the rapid urease test and histopathology for H. pylori on gastric biopsies. The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of this test were calculated against the histopathology. RESULTS Among 92 patients, H. pylori was detected by histopathology and rapid urease test in 61 (66%) and 56 (60%) patients, respectively. Meanwhile the serological test diagnosed current H. pylori infection in 55 patients (59%). On comparison against the histology, the sensitivity and specificity of this new serological test was 85 and 90%, respectively. The positive predictive value and negative predictive value of this test were 94 and 76%, and the accuracy was 87% in this study. CONCLUSION The specificity and sensitivity of the serological test was found comparable with histopathology in the diagnosis of current H. pylori infection. This test is a useful tool for rapid diagnosis of H. pylori in out patients' setting.
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Affiliation(s)
- Khalid Mumtaz
- Section of Gastroenterology, Department of Medicine, The Aga Khan University Hospital, Karachi, Pakistan
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Kawakami K, Kawai T, Kataoka M, Takei K, Taira S, Itoi T, Moriyasu F, Takagi Y, Aoki T, Matsubayasiu J, Mukai K, Rimbara E, Noguchi N, Sasatsu M. Comparison of the HM-CAP and E-Plate Serum Antibody Kit for the Assessment of Helicobacter pylori Eradication in Japan. J Clin Biochem Nutr 2006. [DOI: 10.3164/jcbn.38.39] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022] Open
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Kuo FC, Wang SW, Wu IC, Yu FJ, Yang YC, Wu JY, Wang WM, Wu DC. Evaluation of urine ELISA test for detecting Helicobacter pylori infection in Taiwan: A prospective study. World J Gastroenterol 2005; 11:5545-8. [PMID: 16222752 PMCID: PMC4320369 DOI: 10.3748/wjg.v11.i35.5545] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.5] [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: To evaluate the diagnostic accuracy and clinical utility of a new ELISA (URINELISA) test for detecting Helicobacter pylori (H pylori) antibody in the urine of Taiwanese population.
METHODS: In this prospective study, 317 consecutive dyspeptic patients (171 men, 146 women; mean age, 51.0 years) were included. They underwent gastroendoscopy for evaluation. Invasive tests, including culture, histology, and rapid urease test (RUT), and non-invasive 13C-urea breath test were preformed. At the same time, urine specimens were collected for URINELISA. The status of H pylori infection was considered as positive when either culture was positive, or when two of the other, RUT, histology or 13C-UBT, were positive.
RESULTS: The sensitivity, specificity, positive predictive value, and negative predictive value of URINELISA are 91.7% (211/230), 90.8% (79/87), 96.3% (211/219), and 80.6% (79/98) respectively.
CONCLUSION: This URINELISA test is reliable, inexpensive and easy-to-use. The high diagnostic accuracy warrants the use of URINELISA as a first-line screening tool for diagnosis of H pylori infection in untreated patients.
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Affiliation(s)
- Fu-Chen Kuo
- Department of Gynecology and Obstetrics, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan, China
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Wu KC, Li HT, Qiao TD, Li CN, Ji WS, Tian FQ, Wang X, Wang BL, Miao JY, Ding J, Fan DM. Diagnosis of atrophic body gastritis in Chinese patients by measuring serum pepsinogen. ACTA ACUST UNITED AC 2005; 5:22-7. [PMID: 15612668 DOI: 10.1111/j.1443-9573.2004.00148.x] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
OBJECTIVE Atrophic body gastritis (ABG) is common in China. Although histology via endoscopy is an efficient and reliable means of diagnosing ABG, it is an invasive procedure. Therefore, in the present study serum pepsinogen (PG) was used as a biomarker to develop a novel noninvasive test as the first option for screening of ABG in certain groups of Chinese. METHODS The study population consisted of 81 selected dyspeptic patients (mean age, 64.8 +/- 0.7 years; M:F, 43:38) who underwent diagnostic gastroscopy. At least four biopsy specimens were taken from the antrum and corpus of the stomach (two specimens from each site) for histological diagnosis. Blood samples for ELISA assays of serum pepsinogen I (PGI), pepsinogen II (PGII) and IgG antibodies against Helicobacter pylori (Hp IgG) were drawn after endoscopy. Cut-off points were calculated using receiver operating curves (ROC). RESULTS There was no correlation between serum PG and atrophy in the antral mucosa. The mean serum concentration of PGI was lower (P < 0.05) in patients with ABG (89.9 microg/L) than in those with normal mucosa (NM) and non-ABG (123.7 microg/L and 139.1 microg/L). The mean ratio of PGI:PGII was also lower (P < 0.01) in patients with ABG (6.2) than in those with NM and non-ABG (11.6 and 11.7). There was no difference in serum PGI or the PGI:PGII ratio between patients with and without H. pylori infection. For diagnosing ABG, the area under the ROC of PGI and the PGI:PGII ratio was 0.741 (95% CI: 0.627-0.856) and 0.874 (95% CI: 0.788-0.961), respectively. The maximum of the Youden's index (YI) of PGI and the PGI:PGII ratio was 0.426 and 0.722, respectively. The best cut-off point for PGI was 97.1 microg/L with sensitivity of 67% and specificity of 76%, and for PGI:PGII ratio was 8.1 microg/L, with sensitivity of 89% and specificity of 83%. CONCLUSIONS The serum PGI:PGII ratio appears to be a sensitive and specific assay for corpus atrophy, thus providing a noninvasive and indicative test for diagnosis of atrophic gastritis.
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Affiliation(s)
- Kai Chun Wu
- Department of Gastroenterology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China
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Hanvivatvong O, Pongpanich A, Thong-Ngam D, Thammacharoenrach N, Kullavanijaya P. Evaluation of commercial immunoassays for detection of antibody against Helicobacter pylori in Thai dyspeptic patients. CLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY 2005; 11:618-20. [PMID: 15138191 PMCID: PMC404578 DOI: 10.1128/cdli.11.3.618-620.2004] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
The performance of five immunoassays for detection of immunoglobulin G antibody against Helicobacter pylori in 191 dyspeptic patients was evaluated. The sensitivities, specificities, accuracies, positive predictive values, and negative predictive values ranged from 86.32 to 97.89%, 57.95 to 72.22%, 77.02 to 83.76%, 71.54 to 77.42%, and 83.33 to 96.23%, respectively. The immunoglobulin A test kit also gave a high sensitivity and negative predictive value (95.79 and 91.40%, respectively), while the specificity was relatively low (51.14%).
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Affiliation(s)
- Orrawadee Hanvivatvong
- Department of Microbiology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.
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26
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Obata Y, Kikuchi S, Miwa H, Yagyu K, Lin Y, Ogihara A. Diagnostic accuracy of serological kits for Helicobacter pylori infection with the same assay system but different antigens in a Japanese patient population. J Med Microbiol 2003; 52:889-892. [PMID: 12972583 DOI: 10.1099/jmm.0.05267-0] [Citation(s) in RCA: 26] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022] Open
Abstract
Helicobacter pylori infection is thought to be a causal risk factor for gastric carcinoma. Recently, diagnostic accuracy of serological kits for H. pylori infection that were made in Western countries has been reported to be lower when used among Oriental populations. Diagnostic accuracy of two serological kits [HM-CAP and HM-CAP with antigens extracted from clinically isolated Japanese H. pylori strains (J-HM-CAP)] was investigated in 440 samples from a Japanese patient population by using the (13)C-urea breath test as gold standard. According to the original optimal cut-off value, HM-CAP provided 87.5 % sensitivity and 84.8 % specificity with 86.8 % accuracy and J-HM-CAP provided 95.5 % sensitivity and 81.9 % specificity with 92.3 % accuracy. This study suggests that antigens from HM-CAP are satisfactory for examining a Japanese patient population, but that using local antigens improves accuracy.
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Affiliation(s)
- Yuki Obata
- Department of Public Health, Aichi Medical University, School of Medicine, 21, Karimata, Yazako, Nagakute-cho, Aichi-Gun, Aichi 480-1195, Japan 2Department of Gastroenterology, Juntendo University, School of Medicine, 2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan 3Faculty of Science and Technology, Tokyo University of Science, Yamaguchi, 1-1-1, Daigakudori, Onoda, Yamaguchi 756-0884, Japan
| | - Shogo Kikuchi
- Department of Public Health, Aichi Medical University, School of Medicine, 21, Karimata, Yazako, Nagakute-cho, Aichi-Gun, Aichi 480-1195, Japan 2Department of Gastroenterology, Juntendo University, School of Medicine, 2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan 3Faculty of Science and Technology, Tokyo University of Science, Yamaguchi, 1-1-1, Daigakudori, Onoda, Yamaguchi 756-0884, Japan
| | - Hiroto Miwa
- Department of Public Health, Aichi Medical University, School of Medicine, 21, Karimata, Yazako, Nagakute-cho, Aichi-Gun, Aichi 480-1195, Japan 2Department of Gastroenterology, Juntendo University, School of Medicine, 2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan 3Faculty of Science and Technology, Tokyo University of Science, Yamaguchi, 1-1-1, Daigakudori, Onoda, Yamaguchi 756-0884, Japan
| | - Kiyoko Yagyu
- Department of Public Health, Aichi Medical University, School of Medicine, 21, Karimata, Yazako, Nagakute-cho, Aichi-Gun, Aichi 480-1195, Japan 2Department of Gastroenterology, Juntendo University, School of Medicine, 2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan 3Faculty of Science and Technology, Tokyo University of Science, Yamaguchi, 1-1-1, Daigakudori, Onoda, Yamaguchi 756-0884, Japan
| | - Yingsong Lin
- Department of Public Health, Aichi Medical University, School of Medicine, 21, Karimata, Yazako, Nagakute-cho, Aichi-Gun, Aichi 480-1195, Japan 2Department of Gastroenterology, Juntendo University, School of Medicine, 2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan 3Faculty of Science and Technology, Tokyo University of Science, Yamaguchi, 1-1-1, Daigakudori, Onoda, Yamaguchi 756-0884, Japan
| | - Atsushi Ogihara
- Department of Public Health, Aichi Medical University, School of Medicine, 21, Karimata, Yazako, Nagakute-cho, Aichi-Gun, Aichi 480-1195, Japan 2Department of Gastroenterology, Juntendo University, School of Medicine, 2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan 3Faculty of Science and Technology, Tokyo University of Science, Yamaguchi, 1-1-1, Daigakudori, Onoda, Yamaguchi 756-0884, Japan
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Marchildon PA, Sugiyama T, Fukuda Y, Peacock JS, Asaka M, Shimoyama T, Graham DY, Fukada Y. Evaluation of the effects of strain-specific antigen variation on the accuracy of serologic diagnosis of Helicobacter pylori infection. J Clin Microbiol 2003; 41:1480-5. [PMID: 12682133 PMCID: PMC153909 DOI: 10.1128/jcm.41.4.1480-1485.2003] [Citation(s) in RCA: 46] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022] Open
Abstract
It has been suggested that enzyme immunoassay (EIA) kits validated in one region may yield variable diagnostic performance results in different regions, possibly due to strain-specific differences in antibody responses in different populations. We tested (13)C-urea breath test-characterized serum samples from 109 U.S. patients and 288 Japanese patients using enzyme immunoassay with different preparations of high-molecular-weight cell-associated (HM-CAP) antigens that are conserved across Helicobacter pylori strains. Replicate antigens were prepared from five H. pylori clinical isolates. Eight antigen preparations were evaluated: two of U.S. origin and six of Japanese origin. The accuracies achieved with the eight antigen preparations ranged from 94.4 to 96.3% with the U.S. samples. With the Japanese samples the accuracies achieved ranged from 92.3 to 97.2%. Use of a pool of HM-CAP antigens prepared from isolates from Japan resulted in a higher median enzyme immunoassay value and slightly fewer samples with indeterminate results compared to the results obtained by use of the U.S. standard HM-CAP antigen for H. pylori-positive patients (accuracies, 97.2 and 92.3%, respectively), suggesting that variations in performance between both antigen source and patient population might be reduced by using antigens pooled from several strains.
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Abstract
The actual distribution of Helicobacter pylori infection and its related diseases in various Asian countries is controversial. Only limited information is available regarding this issue. We discuss the etiological role of H. pylori in gastric cancer through the Asian experience. Seroprevalence of H. pylori infection in asymptomatic subjects and the annual incidence rate of gastric cancer per 100,000 in various Asian countries are summarized from literature reviews and World Health Organization statistics, respectively. There is a large intercountry variation in incidence of gastric cancer and H. pylori seroprevalence among Asian countries. There is a strong link between H. pylori infection and gastric cancer in many countries, such as Japan. By contrast, the prevalence of H. pylori infection is high in some countries, including India and Bangladesh, but low gastric cancer rates have been reported. These disparate observations represent the Asian enigma. Factors that may influence the etiology of gastric cancer include the genetic diversity of the infecting H. pylori strains and differences in the host genetic background in various ethnic groups, including gastric acid secretion and genetic polymorphisms in proinflammatory cytokines. These factors, in addition to environmental factors, such as personal hygiene and dietary habits, reflect the multifactorial etiology of gastric cancer.
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Affiliation(s)
- Hiroto Miwa
- Department of Gastroenterology, Juntendo University, School of Medicine, Tokyo, Japan
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Xia HHX, Wong BCY, Wong WM, Tang VSY, Cheung HKL, Sham FNF, Fung FMY, Lai KC, Hu WHC, Chan CK, Lam SK. Optimal serological tests for the detection of Helicobacter pylori infection in the Chinese population. Aliment Pharmacol Ther 2002; 16:521-526. [PMID: 11876706 DOI: 10.1046/j.1365-2036.2002.01176.x] [Citation(s) in RCA: 18] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
BACKGROUND Numerous serological tests for the detection of Helicobacter pylori infection have been developed. However, many perform poorly when evaluated in the Chinese population. AIM To search for optimal serological tests for the detection of H. pylori infection in Chinese patients. METHODS Consecutive dyspeptic patients referred for upper endoscopy were recruited. During endoscopy, gastric biopsies were taken for the CLOtest and histological examination. Patients were then given a 13C-urea breath test. Sera were used to test for H. pylori infection, employing three commercial enzyme-linked immunosorbent assay kits (pylori DTect, HP IgG and GAP IgG). Results were compared with the gold standard defined by the CLOtest, histology and 13C-urea breath test. RESULTS Among the 142 patients (47 male, 95 female; mean age, 49 years) recruited, 81 (57%) were H. pylori-positive, 57 (40%) were H. pylori-negative and four (3%) were defined to be indeterminate. Using a self-defined cut-off value after calculation, the best accuracies for the pylori DTect, HP IgG and GAP IgG tests were 97%, 91% and 80%, respectively. CONCLUSIONS The pylori DTect test is an optimal serological test for the detection of H. pylori infection in Hong Kong Chinese patients. The HP IgG test may be used as an alternative.
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Affiliation(s)
- H H-X Xia
- Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong
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Hung CT, Leung WK, Chan FK, Sung JJ. Comparison of two new rapid serology tests for diagnosis of Helicobacter pylori infection in Chinese patients. Dig Liver Dis 2002; 34:111-5. [PMID: 11926553 DOI: 10.1016/s1590-8658(02)80239-0] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
BACKGROUND Rapid serology test is a simple and convenient way for diagnosing Helicobacter pylori infection. However performances of these tests are usually less satisfactory than expected, particularly in developing countries. AIM To evaluate the performances of two newly developed rapid serology tests for Helicobacter pylori infection. PATIENTS Consecutive Chinese dyspeptic patients undergoing upper gastrointestinal endoscopy. METHODS Gastric biopsies were obtained from antrum and corpus for rapid urease test and histological examination. Diagnosis of Helicobacter pylori infection was based on two or more positive results in rapid urease test, histology and [13C] urea breath test. Patients' sera were tested against two rapid serology tests: ASSURE Hp Rapid Test (Genelabs Diagnostics, Singapore) and SureStep (Applied Biotech, San Diego, CA, USA). RESULTS A total of 148 patients were evaluated and Helicobacter pylori infection was diagnosed in 78 (53%) patients by gold standard. The sensitivities of ASSURE Hp and SureStep were, respectively, 94% and 71% (p=0.0003). Specificities of the two test kits were both 90%. The overall accuracy of ASSURE Hp was significantly higher than SureStep (92% versus 80%, p=0.004). CONCLUSION Both rapid serology tests appear to be specific in diagnosing Helicobacter pylori infection in the Chinese populations. However the ASSURE Hp test is more sensitive and accurate than the SureStep test.
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Affiliation(s)
- C T Hung
- Department of Medicine & Therapeutics, the Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong
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31
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Sung JJ, Lao WC, Lai MS, Li TH, Chan FK, Wu JC, Leung VK, Luk YW, Kung NN, Ching JY, Leung WK, Lau J, Chung SJ. Incidence of gastroesophageal malignancy in patients with dyspepsia in Hong Kong: implications for screening strategies. Gastrointest Endosc 2001; 54:454-8. [PMID: 11577306 DOI: 10.1067/mge.2001.118254] [Citation(s) in RCA: 38] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
BACKGROUND A "test-and-treat" strategy for H pylori infection has been recommended in Europe and North America as safe and cost-effective for management of patients with dyspepsia. The primary aim of this study was to determine the frequency of gastroesophageal cancer in 2 groups of patients with dyspepsia: those 45 years of age or younger without "alarm" symptoms (low-risk group) and patients over 45 years of age or any patient with "alarm" symptoms (high-risk group). A secondary aim was to determine the frequency of gastric cancer among patients in the low-risk group with or without a positive serology for H pylori. METHODS Patients with persistent dyspepsia were recruited from 4 regional hospitals in Hong Kong. Those in the low-risk group were evaluated for H pylori by using a whole blood serology test; they underwent endoscopy within 1 week. Those in the high-risk group and those taking nonsteroidal anti-inflammatory drugs (NSAIDs) underwent endoscopy promptly. Alarm symptoms were as follows: weight loss (10 or more pounds over 8 weeks), recurrent vomiting, dysphagia, bleeding, or anemia. RESULTS Of 2627 patients enrolled, 1017 were in the low-risk group and 1610 in the high-risk group. Twenty-three patients (0.9%) had gastroesophageal cancers (20 gastric, 3 esophageal). Four patients with cancer (17.4%) were in the low-risk group (3 gastric, 1 esophageal); all except the patient with esophageal cancer had a positive serology test. In the high-risk group, 19 patients had cancer (17 gastric, 2 esophageal). CONCLUSION Gastric cancer is relatively frequent among young patients with dyspepsia who have no alarm features in Hong Kong. This finding raises concerns as to the safety of the "test-and-treat" strategy for the management of patients with dyspepsia in Asia.
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Affiliation(s)
- J J Sung
- Department of Medicine and Therapeutics, Prince of Wales Hospital, Shatin, NT, Hong Kong
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Watanabe K, Joh T, Seno K, Sasaki M, Todoroki I, Miyashita M, Tochikubo K, Itoh M. Development and clinical application of an immunoassay using intact Helicobacter pylori attached to a solid phase as an antigen. Clin Biochem 2001; 34:291-5. [PMID: 11440729 DOI: 10.1016/s0009-9120(01)00202-8] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/06/2023]
Abstract
OBJECTIVE At present, H. pylori homogenates, extracts and recombinant proteins are used as antigens in immunoassays, but significant false positive and negative results are obtained. We attempted to develop an ELISA system using immobilized whole intact H. pylori cells as a solid phase antigen (WIC-ELISA) which specifically recognizes surface antigens. METHODS Intact H. pylori cells were immobilized on ELISA plates by centrifugation (150 g for 10 min). HRP-labeled antihuman IgG was used as the second antibody. H. pylori-infections were investigated with WIC-ELISA and a conventional method in which H. pylori-extracts were used as antigen in 117 patients. RESULTS WIC-ELISA showed better characteristics than conventional ELISA in regards to sensitivity (98.9 vs. 90.4%), specificity (95.7 vs. 95.7%), positive predictive value (98.9 vs. 98.8%), negative predictive value (95.7 vs. 71.0%) and accuracy (98.3 vs. 91.5%). CONCLUSIONS WIC-ELISA is useful for quantification of antibodies against H. pylori surface antigens and as a clinical screening test.
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Affiliation(s)
- K Watanabe
- The First Department of Internal Medicine, Nagoya City University Medical School, Nagoya, Japan
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Szeto ML, Lee CK, Yee YK, Li KF, Lee WK, Lee CC, Que TL, Wong BC. Evaluation of five commercial serological tests for the detection of Helicobacter pylori infection in Chinese. Aliment Pharmacol Ther 2001; 15:703-6. [PMID: 11328265 DOI: 10.1046/j.1365-2036.2001.00961.x] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
Abstract
BACKGROUND Commercial serological tests for the detection of Helicobacter pylori infection must be locally validated. We evaluated the accuracy of five commercial tests in the Chinese population. METHODS Serum samples were collected from patients referred for upper endoscopy. Antral biopsies were taken for histological examination and culture of H. pylori. The gold standard for diagnosing H. pylori infection was positive histological staining and/or positive H. pylori culture. The serum samples were tested for H. pylori antibodies using the following tests: (i) Cobas Core Anti-H. pylori EIA; (ii) GAP IgG; (iii) GAP IgM; (iv) H. pylori microwell EIA (Quidel); and (v) Premier H. pylori. The sensitivity, specificity and accuracy of each test was calculated according to the manufacturers' instructions or according to a new cut-off value. RESULTS A total of 158 patients were recruited amongst whom 114 (72%) were H. pylori-positive. Indeterminate results varied from 7% to 19%. The accuracy of the tests varied from 57% to 85%. By using new cut-off values, the accuracy was much improved, ranging from 73.4% to 86.7%. CONCLUSIONS By defining new cut-off values for the Chinese population, we were able to improve the performance of some of the serology tests. This illustrates the importance of local validation.
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Affiliation(s)
- M L Szeto
- Department of Medicine and Geriatrics, Tuen Mun Hospital, Hong Kong.
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Wong BC, Wong WM, Wang WH, Tang VS, Young J, Lai KC, Yuen ST, Leung SY, Hu WH, Chan CK, Hui WM, Lam SK. An evaluation of invasive and non-invasive tests for the diagnosis of Helicobacter pylori infection in Chinese. Aliment Pharmacol Ther 2001; 15:505-11. [PMID: 11284779 DOI: 10.1046/j.1365-2036.2001.00947.x] [Citation(s) in RCA: 50] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
BACKGROUND Different tests are available for diagnosing Helicobacter pylori infection. AIM To compare the most commonly used tests either alone or in combination in Chinese patients with respect to routine clinical use or research purpose. METHODS A total of 294 consecutive dyspeptic patients without previous H. pylori treatment were recruited. During upper endoscopy, biopsies were taken from the antrum and corpus, for a commercially available CLO-test, an in-house rapid urease test, culture, polymerase chain reaction and histological examination. Patients then received a 13C-urea breath test. The H. pylori status of each patient was determined by a concordance of test results. RESULTS For routine clinical use, histology (antral plus corpus biopsies) had an accuracy of 100%, whilst the rapid urease test had an accuracy of 99.7%. The 13C-urea breath test was equally reliable, with an accuracy of 94.5%. Combinations of two tests did not confer additional advantage over the most accurate single test. For research purposes, the accuracy of using the criteria of two positives out of three diagnostic tests was 100% and equivocal results were not found. CONCLUSION Histology with or without a rapid urease test was highly accurate for routine clinical use. Alternatively, the 13C-urea breath test was an equally reliable non-invasive test. The two positives out of three tests approach was highly reliable in predicting H. pylori status of untreated Chinese patients in a research setting.
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Affiliation(s)
- B C Wong
- Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong.
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Leung WK, Chow TP, Ng EK, Chan FK, Chung SC, Sung JJ. Validation of a new immunoblot assay for the diagnosis of Helicobacter pylori in the Asian population. Aliment Pharmacol Ther 2001; 15:423-8. [PMID: 11207519 DOI: 10.1046/j.1365-2036.2001.00899.x] [Citation(s) in RCA: 18] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/26/2023]
Abstract
BACKGROUND Performance of commercial serological tests for Helicobacter pylori varies in different populations, largely due to strain heterogeneity and variations in antigenic preparations. Currently available serology tests often show sub-optimal accuracy when used for Asian patients. AIM This study evaluated a recombinant antigen-based immunoblot for the diagnosis of H. pylori infection in Chinese patients, and compared it with a conventional ELISA test. METHODS Dyspeptic patients referred for diagnostic endoscopy were recruited. The gold standard for H. pylori infection was based on two or more positive results among rapid urease test, histology and (13)C-urea breath test. Serological diagnosis of H. pylori infection was conducted by an ELISA test (pylori DTect; Diagnostic Technology) and an immunoblotting against a novel recombinant antigen (C1S; Genelab), which was constructed by immunological screening of the genomic DNA library of H. pylori. RESULTS A total of 87 patients were evaluated and H. pylori infection was diagnosed in 40 (46%) by the reference tests. The sensitivities of the ELISA and immunoblot were 80% (95% CI: 64--91%) and 90% (95% CI: 76--97%), whilst the specificities were 96% (95% CI: 86--96%) and 87% (95% CI: 74--95%), respectively. The respective likelihood ratios of the two tests were 18.6 and 7.0. CONCLUSIONS Satisfactory performance is obtained by the use of the new recombinant antigen-based immunoblot for diagnosing H. pylori infection in Chinese patients.
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Affiliation(s)
- W K Leung
- Department of Medicine & Therapeutics, Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong.
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Miwa H, Akamatsu S, Tachikawa T, Sogabe T, Ohtaka K, Nagahara A, Sugiyama Y, Sato N. On-site diagnosis of H. pylori infection by urine. Diagn Microbiol Infect Dis 2001; 39:95-7. [PMID: 11248521 DOI: 10.1016/s0732-8893(01)00205-x] [Citation(s) in RCA: 14] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/18/2022]
Abstract
We have recently developed an on-site diagnostic kit for H. pylori infection using urine (utilizing immunochromatographic method employing a nitrocellulose membrane coated by extracted H. pylori antigen). Accordingly, we investigated its usefulness in 155 consecutive dyspeptic patients using the 13C urea breath test as a gold standard and further compared its performance with two commercially available rapid diagnostic kits that use whole blood (Helisal Rapid Blood, and ImmunoCard H. pylori). As the results, the urine based on-site diagnostic kit provided 95.9% sensitivity and 87.9% specificity with 92.9% accuracy, which were comparable or even better than that of both rapid whole blood tests, suggesting its usefulness in screening of H. pylori infection.
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Affiliation(s)
- H Miwa
- Department of Gastroenterology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyoku, 113-8421, Tokyo, Japan.
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Zhou H, Chan KL, Chu KM, Tam PK. Intrafamilial spread of Helicobacter pylori: a prospective study using urea breath test. J Pediatr Surg 2000; 35:1672-5. [PMID: 11083450 DOI: 10.1053/jpsu.2000.18349] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
Abstract
PURPOSE The mode of Helicobacter pylori spread is not well defined. Urea breath test (UBT) is an accurate and noninvasive method for H pylori detection. This study evaluates the role of intrafamilial spread of H pylori using UBT. METHODS The family members of 16 Hpylori-positive and 16 negative (control) children confirmed by histology and rapid urease test were investigated with UBT. A 58% change was considered positive. RESULTS A total of 139 persons (72 in the positive group; 67 in the control group) were studied. Fifty-eight (81%, 58 of 72) and 13 (19%, 13 of 67) were found to be positive in the H pylori-positive and control groups, respectively (P < .01). Among children from 19 positive mothers, the positive rate was 60% (25 of 42), whereas among children of negative mothers, the positive rate was 16% (4 of 25; P < .01). The positive rate among children of positive fathers was 66% (23 of 35), whereas that among children of negative fathers was 30% (7 of 23; P < .01). When both parents were H pylori-positive, the children's positive rate was 83% (19 of 23); when both parents were negative, the children's positive rate was 0% (0 of 9; P < .01). CONCLUSIONS There is strong evidence of intrafamilial spread of H pylori. The positivity of parents with H pylori has an important bearing on their children's H pylori status.
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Affiliation(s)
- H Zhou
- Department of Surgery, The University of Hong Kong Medical Center, Queen Mary Hospital, Hong Kong, SAR, China
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Miwa H, Kikuchi S, Ohtaka K, Kobayashi O, Ogihara A, Hojo M, Nagahara A, Sato N. Insufficient diagnostic accuracy of imported serological kits for Helicobacter pylori infection in Japanese population. Diagn Microbiol Infect Dis 2000; 36:95-9. [PMID: 10705050 DOI: 10.1016/s0732-8893(99)00143-1] [Citation(s) in RCA: 32] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/03/2023]
Abstract
Although there are many reports of the high diagnostic accuracy of commercially available serologic kits for Helicobacter pylori infection in Western countries, they rarely has been investigated in oriental population. Accordingly we examined their usefulness in 492 Japanese patients with dyspeptic symptoms. Diagnostic accuracy of 4 imported serologic kits (HEL-p TEST, HM CAP, G.A.P IgG, Helico G2) was investigated using the (13)C-urea breath test as the gold standard. When intermediate results were excluded, the sensitivity, specificity and accuracy of these serologic tests ranged from 88.6% to 97.8%, 67.9% to 85.9%, and 87.9% to 91.4%, respectively, which were comparable with reported median accuracy in the Western population. However, there were many intermediate results in these tests, ranging from 5.3% to 23.0%. Their usefulness seemed to be limited in our patient population because of the large number of intermediate results.
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Affiliation(s)
- H Miwa
- Department of Gastroenterology, Juntendo University, School of Medicine, 2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
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Miwa H, Hirose M, Kikuchi S, Terai T, Iwazaki R, Kobayashi O, Takei Y, Ogihara T, Sato N. How useful is the detection kit for antibody to Helicobacter pylori in urine (URINELISA) in clinical practice? Am J Gastroenterol 1999; 94:3460-3. [PMID: 10606303 DOI: 10.1111/j.1572-0241.1999.01608.x] [Citation(s) in RCA: 38] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVE Increased knowledge of the significance of Helicobacter pylori (H. pylori) infection in gastric disorders has accelerated the trend of screening patients with dyspepsia for its infection. Serological examination of antibody for H. pylori has been widely performed. Recently, a urine-based enzyme-linked immunosorbent assay (URINELISA) kit for detection of antibody for H. pylori has been developed. Accordingly, we evaluated its diagnostic accuracy in clinical practice. METHODS Subjects of this study were 132 patients who presented at our university hospital because of dyspeptic symptoms (81 men, 51 women; age, 41.5+/-1.4 yr). 13C urea breath test, blood drawing for serological antibody for H. pylori infection by four different kits, and urine collection for the URINELISA test for detection of the antibody were performed. Diagnostic accuracy of the commercially available antibodies in serum and in urine were investigated using the results of the 13C urea breath test as the gold standard. RESULTS Sensitivity, specificity, and accuracy of URINELISA were 86.3% (95% confidence intervals [CI], 76-93%), 91.5% (95% CI, 81-97%), and 88.6% (95% CI, 82-93%), respectively, which were comparable to those of imported serological kits. CONCLUSIONS The URINELISA kit for detecting anti-H. pylori antibody in urine provides diagnostic accuracy comparable to that of imported kits for detecting antibodies in serum and is considered to be clinically useful for the diagnosis of H. pylori infection.
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Affiliation(s)
- H Miwa
- Department of Gastroenterology, Juntendo University, School of Medicine, Tokyo, Japan
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