title: Evaluation of the two immunochromatographic methods for detecting urine and serum IgG antibodies to Helicobacter pylori and comparison of accuracy and clinical utility.
abstract: OBJECTIVE
  To evaluate the accuracy and clinical utility of two immunochromatographic methods, the STAT-PAK and RAPIRUN tests, in detecting H. pylori antibodies in serum and in urine separately.
  
  
  METHODS
  130 patients undergoing gastroendoscopy (70 men and 60 women; mean age, 50.6 years) were enrolled in this study. Their H. pylori status was determined based on 4 tests: CLO test, culture, histology and UBT test. The H. pylori positive status was confirmed when the culture was positive, or 2 of the other 3 tests were positive. Serum samples and urine samples were collected. We used the STAT-PAK test for detecting H. pylori antibodies in serum, and read the results 24 hours later. Antibodies were also detected in urine by the RAPIRUN test, with a reading time of 25 minutes. 3 doctors read the results of both tests separately, and a positive result was determined when at least 2 of the doctors read a positive result.
  
  
  RESULTS
  In the STAT-PAK pretest using serum samples from 21 randomly selected patients (16 patients with H. pylori infection and 5 patients without infection), the sensitivity at 1-hour and 24-hour reading time was 18.7% and 37.5%. Specificity in both reading times was the same at 100%. Of 129 patients, 82 (64%) were H. pylori infected and 47 (36%) were uninfected. The sensitivity, specificity, and positive and negative predictive values were 31.7%, 93.6%, 89.6% and 44.0% in the STAT-PAK test with a 24-hour reading time, and 93.9%, 85.1%, 91.6%, 88.8% in the RAPIRUN test. One female was excluded because of an invalid urine test.
  
  
  CONCLUSIONS
  The urine RAPIRUN test is a faster and more accurate office-based test than the serum STAT-PAK test for detecting the H. pylori infection in untreated patients in Taiwan. The non-invasive urine RAPIRUN test can be used as a large scale screening test for H. pylori status, particularly in children, uncooperative patients, those who have a family history of gastric cancer, or patients who can not tolerate the suffering of endoscopic examination.
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung City, Taiwan.
authors.forename: Huang-Ming
authors.initials: HM
authors.lastname: Hu
authors.forename: Chao-Hung
authors.initials: CH
authors.lastname: Kuo
authors.forename: Yi-Ching
authors.initials: YC
authors.lastname: Lo
authors.forename: Ming-Tsang
authors.initials: MT
authors.lastname: Wu
authors.forename: I-Chen
authors.initials: IC
authors.lastname: Wu
authors.forename: Chien-Yu
authors.initials: CY
authors.lastname: Lu
authors.forename: Yu-Chung
authors.initials: YC
authors.lastname: Su
authors.forename: Fang-Jong
authors.initials: FJ
authors.lastname: Yu
authors.forename: Yi-Chen
authors.initials: YC
authors.lastname: Lee
authors.forename: Shiu-Ru
authors.initials: SR
authors.lastname: Lin
authors.forename: Chiang-Shin
authors.initials: CS
authors.lastname: Liu
authors.forename: Chang-Ming
authors.initials: CM
authors.lastname: Jan
authors.forename: Wen-ming
authors.initials: WM
authors.lastname: Wang
authors.forename: Deng-Chyang
authors.initials: DC
authors.lastname: Wu
mesh_terms: D000328:Adult; D000368:Aged; D000907:Antibodies, Bacterial / Q000032:analysis* / Q000097:blood / Q000652:urine; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D007074:Immunoglobulin G / Q000032:analysis*; D008297:Male; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D000907:Antibodies, Bacterial; D007074:Immunoglobulin G; D011933:Reagent Kits, Diagnostic