title: A Creative Helicobacter pylori Diagnosis Scheme Based on Multiple Genetic Analysis System: Qualification and Quantitation.
abstract: BACKGROUND
  Currently, several diagnostic assays for Helicobacter pylori (H. pylori) are available, but each has some limitations. Further, a high-flux quantitative assay is required to assist clinical diagnosis and monitor the effectiveness of therapy and novel vaccine candidates.
  
  
  METHODS
  Three hundred and eighty-seven adult patients [nonulcer dyspepsia (NUD) 295, peptic ulcer disease (PUD) 77, gastric cancer (GC) 15] were enrolled for gastrointestinal endoscopies. Three biopsy samples from gastric antrum were collected for the following tests: culture, rapid urease test (RUT), histopathology, conventional polymerase chain reaction (PCR), and Multiple Genetic Analysis System (MGAS). The diagnostic capability of H. pylori for all methods was evaluated through the receiver operating characteristic (ROC) curves.
  
  
  RESULTS
  Based on the gold standard, the sensitivity and specificity of MGAS were 92.9 and 92.4%, and positive predict value (PPV) and negative predict value (NPV) were 96.0 and 87.1%, respectively. All the above parameters of MGAS were higher than that of culture (except its specificity), RUT and histopathology, and nearly closed to that of conventional PCR. The area under curve (AUC) was 0.7575 (Culture), 0.8870 (RUT), 0.9000 (Histopathology), 0.9496 (Conventional PCR), and 0.9277 (MGAS). No significant statistical difference was observed for the H. pylori DNA load in different disease groups (p = .067). In contrast, a statistically significant difference in the H. pylori DNA copy number was observed based on age (p = .043) and gender (p = .021).
  
  
  CONCLUSIONS
  The data showed that MGAS performed well in detecting H. pylori infection. Furthermore, the quantitative analysis showed that the load of H. pylori was significantly different within both age and gender groups. These results suggested that MGAS could be a potential alternative method for clinical detection and monitoring of the effectiveness of H. pylori therapy.
authors: Department of Laboratory Medicine, Laboratory of Molecular Biology, Huadong Hospital affiliated to, Fudan University, Shanghai, China.
authors: Lifang
authors: L
authors: Zhou
authors: Department of Laboratory Medicine, Laboratory of Molecular Biology, Huadong Hospital affiliated to, Fudan University, Shanghai, China.
authors: Fuju
authors: F
authors: Zhao
authors: Department of Laboratory Medicine, Laboratory of Molecular Biology, Huadong Hospital affiliated to, Fudan University, Shanghai, China.
authors: Binjie
authors: B
authors: Hu
authors: Department of Laboratory Medicine, Laboratory of Molecular Biology, Huadong Hospital affiliated to, Fudan University, Shanghai, China.
authors: Yi
authors: Y
authors: Fang
authors: Department of Laboratory Medicine, Laboratory of Molecular Biology, Huadong Hospital affiliated to, Fudan University, Shanghai, China.
authors: Yingxin
authors: Y
authors: Miao
authors: Department of Gastroenterology, Gerontology Institute of Shanghai affiliated to, Huadong Hospital, Fudan University, Shanghai, China.
authors: Yiqin
authors: Y
authors: Huang
authors: Department of Endoscopy, Huadong Hospital, Fudan University, Shanghai, China.
authors: Da'nian
authors: D
authors: Ji
authors: Department of Laboratory Medicine, Laboratory of Molecular Biology, Huadong Hospital affiliated to, Fudan University, Shanghai, China.
authors: Jinghao
authors: J
authors: Zhang
authors: Shanghai AB Sciex Analytical Instrument Trading Co., Ltd, Shanghai, China.
authors: Lingli
authors: L
authors: Xu
authors: Shanghai Shine Clinical Laboratories, Inc., The Research base of MDT, DCMST, Ministry of Health, Shanghai, China.
authors: Yanmei
authors: Y
authors: Zhang
authors: Department of Gastroenterology, Gerontology Institute of Shanghai affiliated to, Huadong Hospital, Fudan University, Shanghai, China.
authors: Zhijun
authors: Z
authors: Bao
authors: Department of Laboratory Medicine, Laboratory of Molecular Biology, Huadong Hospital affiliated to, Fudan University, Shanghai, China.
authors: Hu
authors: H
authors: Zhao
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001431:Bacteriological Techniques / Q000379:methods*; D001706:Biopsy; D003955:Diagnostic Tests, Routine / Q000379:methods*; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005753:Gastric Mucosa / Q000382:microbiology / Q000473:pathology; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006651:Histocytochemistry / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D055815:Young Adult
keywords: Diagnosis scheme; Helicobacter pylori; Multiple Genetic Analysis System; Peptic ulcer; Qualification; Quantitation