title: Development of an immunochromatographic lateral flow device for rapid detection of Helicobacter pylori stool antigen.
abstract: OBJECTIVE
  Helicobacter pylori stool antigen (HpSA) test is a convenient and reliable non-invasive diagnosis for H. pylori infection. The aim of this study is to develop an immunochromatographic testing device for rapid detection of HpSA among Chinese patients.
  
  
  METHODS
  Monoclonal antibodies (McAb) targeting H. pylori were developed by conventional methods and paired by sandwich ELISA. The lateral flow device (LFD) was prepared using the selected McAb pair. A total of 867 clinically separated bacterial strains, including 56H. pylori strains, were employed to test the sensitivity and specificity. Subsequently, the LFD was used to test 1200 human fecal samples, with a commercial HpSA testing device as comparison.
  
  
  RESULTS
  Two McAb pairs targeting H. pylori, DF2a/EE10b and IH10b/EE10b, were developed and proven to be of high specificity and sensitivity. After testing the cultures of 56 clinically separated H. pylori strains, the final LFD product was prepared using the mixture of DF2a and IH10b as capture antibodies and EE10b as the detection antibody. The testing threshold for H. pylori culture was 1.0 × 10(4)cfu/mL. The sensitivity and specificity were both 100% for the 867 tested bacterial cultures. The testing results of 1200 fecal samples showed that the positive and negative agreement rates between the homemade LFD and the commercial testing device were 99.75% and 99.87%, respectively.
  
  
  CONCLUSIONS
  Our homemade HpSA LFD can be a very promising testing device for rapid diagnosis and epidemic screening of H. pylori infection among Chinese patients.
authors.affiliation: Key Laboratory of Molecular Biology on Infectious Diseases, Chongqing Medical University, 1 Yixueyuan Road, Yuzhong District, Chongqing 400016, PR China.
authors.forename: Zhen
authors.initials: Z
authors.lastname: Lin
authors.affiliation: Clinical Laboratory, Shandong Jiaotong Hospital, 11 Wuyinshan Road, Tianqiao District, Ji'nan, Shandong Province 250031, PR China.
authors.forename: Shiliang
authors.initials: S
authors.lastname: Cheng
authors.affiliation: Artron BioResearch Inc., 3938 North Fraser Way, Burnaby, BC V5J 5H6, Canada.
authors.forename: Qin
authors.initials: Q
authors.lastname: Yan
authors.affiliation: Clinical Laboratory, Shandong Jiaotong Hospital, 11 Wuyinshan Road, Tianqiao District, Ji'nan, Shandong Province 250031, PR China.
authors.forename: Xinfeng
authors.initials: X
authors.lastname: Liu
authors.affiliation: Clinical Laboratory, Shandong Jiaotong Hospital, 11 Wuyinshan Road, Tianqiao District, Ji'nan, Shandong Province 250031, PR China.
authors.forename: Wen
authors.initials: W
authors.lastname: Zheng
authors.affiliation: The Second Affiliated Hospital of Chongqing Medical University, 76 Linjiang Road, Chongqing 400010, PR China.
authors.forename: Xiaomei
authors.initials: X
authors.lastname: Hu
authors.affiliation: The Second Affiliated Hospital of Chongqing Medical University, 76 Linjiang Road, Chongqing 400010, PR China.
authors.forename: Jie
authors.initials: J
authors.lastname: Li
authors.affiliation: Artron BioResearch Inc., 3938 North Fraser Way, Burnaby, BC V5J 5H6, Canada; Jinan Kangbo Biotechnology. 2711 Ying Xiu Road, Ji'nan, Shandong Province 250101, PR China.
authors.forename: Jun
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Artron BioResearch Inc., 3938 North Fraser Way, Burnaby, BC V5J 5H6, Canada.
authors.forename: Tingxiu
authors.initials: T
authors.lastname: Xiang
authors.affiliation: Jinan Kangbo Biotechnology. 2711 Ying Xiu Road, Ji'nan, Shandong Province 250101, PR China.
authors.forename: Jian
authors.initials: J
authors.lastname: Zheng
authors.affiliation: The Blood Transfusion Department, The Second Affiliated Hospital of Chongqing Medical University, 76 Linjiang Road, Chongqing 400010, PR China.. Electronic address: jian0102@hotmail.com.
authors.forename: Juan
authors.initials: J
authors.lastname: Zhang
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000096:biosynthesis / Q000737:chemistry; D000942:Antigens, Bacterial / Q000032:analysis*; D002846:Chromatography, Affinity / Q000295:instrumentation* / Q000379:methods; D004797:Enzyme-Linked Immunosorbent Assay; D005243:Feces / Q000737:chemistry; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000382:microbiology; D016480:Helicobacter pylori / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D051379:Mice; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D000911:Antibodies, Monoclonal; D000942:Antigens, Bacterial
keywords: Helicobacter pylori; Helicobacter pylori stool antigen; Lateral flow device; Monoclonal antibody; Rapid diagnosis