Improved performance of a rapid office-based stool test for detection of Helicobacter pylori in children before and after therapy

J Clin Microbiol. 2009 Dec;47(12):3980-4. doi: 10.1128/JCM.01204-09. Epub 2009 Oct 21.

Abstract

A modified version of a rapid office based one-step monoclonal immunoassay for detection of Helicobacter pylori antigen in stool samples from children was evaluated against biopsy specimen-based methods and compared to a monoclonal enzyme immunoassay using the same antigen. Blinded stool samples from 185 children (0.3 to 18.2 years) were investigated at the time of upper endoscopy prior to anti-H. pylori therapy; 62 children were H. pylori infected and 123 noninfected according to predefined reference standards. Samples obtained 6 to 8 weeks after anti-H. pylori therapy were available from 58 children (3.8 to 17.7 years) and were compared to results of the [(13)C]urea breath test (14/58 were positive). The rapid stool tests were performed by two independent readers. Of 243 rapid tests performed, 1 (0.4%) was invalid for technical reasons. Equivocal results (very weak line) were reported 16 times by reader 1 and 27 times by reader 2. When equivocal results were considered positive, the two observers agreed on 76 positive and 160 negative results and disagreed on 7 samples (2.9%). The sensitivity was 90.8% for reader 1 and 85.5% for reader 2, and the specificity was 91.0% and 93.4%, respectively. The monoclonal enzyme immunoassay revealed a sensitivity and specificity of 94.7% and 97.6%, respectively. The modified chromatographic immunoassay is a good alternative in settings or situations when the monoclonal enzyme immunoassay or the [(13)C]urea breath test are not available or feasible. In order to improve sensitivity, very weak lines should be considered positive test results.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Antibodies, Monoclonal / immunology
  • Antigens, Bacterial / analysis*
  • Breath Tests
  • Child
  • Child, Preschool
  • Feces / microbiology*
  • Helicobacter Infections / diagnosis*
  • Helicobacter Infections / drug therapy*
  • Helicobacter Infections / microbiology
  • Helicobacter pylori / drug effects*
  • Helicobacter pylori / immunology
  • Helicobacter pylori / isolation & purification*
  • Humans
  • Immunoenzyme Techniques / methods*
  • Infant
  • Observer Variation
  • Sensitivity and Specificity
  • Time Factors
  • Urea / analysis

Substances

  • Antibodies, Monoclonal
  • Antigens, Bacterial
  • Urea