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Comparison between a rapid office-based and ELISA serologic test in screening for Helicobacter pylori in children
Y Elitsur1, C Neace, W E Triest
1Department of Pediatrics, Marshall University School of Medicine, Huntington, WV 25701-0195, USA. yelitsur@musom.marshall.edu
Insights
A rapid Helicobacter pylori (H. pylori) serological test shows comparable accuracy to enzyme immunoassay (EIA) for diagnosing H. pylori infection in children. This rapid test offers a convenient alternative for symptomatic pediatric patients.
Area of Science:
- Pediatric Infectious Diseases
- Diagnostic Immunology
- Gastroenterology
Background:
- Helicobacter pylori (H. pylori) infection diagnosis in children.
- Comparison of rapid serological tests versus standard enzyme immunoassay (EIA).
- Evaluation in both symptomatic and asymptomatic pediatric populations.
Purpose of the Study:
- To compare the diagnostic performance of a rapid immunochromatographic test (FlexSure HP) against a standard EIA method (HM-CAP) for H. pylori detection in children.
- To assess the utility of the rapid test in clinical practice for pediatric H. pylori diagnosis.
Main Methods:
- Retrospective analysis of 1147 serum samples from asymptomatic children.
- Prospective analysis of 62 serum samples from symptomatic children undergoing endoscopy.
- Testing of all samples with both FlexSure HP rapid test and HM-CAP EIA.
Main Results:
- The rapid test demonstrated comparable sensitivity (83-90%) and specificity (90-100%) to EIA for H. pylori infection in symptomatic and asymptomatic children.
- Both methods showed similar sensitivity (60-70%) and specificity (94%) for detecting H. pylori-associated gastritis.
Conclusions:
- The rapid H. pylori serological test is a viable alternative to EIA for diagnosing infection in symptomatic children due to its comparable accuracy and speed.
- The rapid test's utility as a screening tool for asymptomatic children may be limited by a lower positive predictive value compared to EIA.
Background:
The rapid diagnostic serological test for detection of Helicobacter pylori (H. pylori) infection in children has a significant advantage over the standard enzyme immunoassay (EIA) method, for its simplicity and rapid availability of results in a physician's office setting. We compared the immunochromatographic test with a standard enzyme immunoassay test in the pediatric population.
Materials And Methods:
A retrospective analysis of 1147 serum samples from asymptomatic children and prospective analysis of 62 serum samples from symptomatic children undergoing diagnostic upper endoscopy were evaluated for the detection of H. pylori antibody by two commercially available serology tests. Each serum sample was tested by a rapid test (FlexSure HP, SmithKline Diagnostics, Inc.) and compared to the standard EIA method (HM-CAP, Enteric Products, Inc.).
Results:
The rapid test, FlexSure HP, was comparable to the rapid EIA test in screening for H. pylori infection in symptomatic and asymptomatic children with sensitivity and specificity of 83-90% and 90-100%, respectively. Both methods had a comparable sensitivity and specificity for the detection of H. pylori-associated gastritis (60-70% and 94%, respectively).
Conclusion:
The rapid test is comparable to the standard EIA test and may be used by physicians in symptomatic children. The use of FlexSure HP as a screening tool for the prevalence of H. pylori infection in asymptomatic children may be limited by its low positive predictive value compared to the EIA method.