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Comparative Evaluation of 29 Commercial H elicobacter pylori Serological Kits
Author(s) -
Burucoa Christophe,
Delchier JeanCharles,
CourillonMallet Anne,
Korwin JeanDominique,
Mégraud Francis,
Zerbib Frank,
Raymond Josette,
Fauchère JeanLouis
Publication year - 2013
Publication title -
helicobacter
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.206
H-Index - 79
eISSN - 1523-5378
pISSN - 1083-4389
DOI - 10.1111/hel.12030
Subject(s) - serology , rapid urease test , helicobacter pylori , gold standard (test) , medicine , youden's j statistic , predictive value , helicobacter pylori infection , gastroenterology , antibody , immunology
Abstract Background Serology is a noninvasive diagnostic method for the detection of H elicobacter pylori infection. Many commercial kits are now on the market. It is necessary to assess their performances to help the user to choose the most appropriate. Material and Methods The performances of 29 commercial serological tests detecting antibodies to H elicobacter pylori (17 enzyme‐linked immunosorbent assay and 12 near‐patient tests) were evaluated using sera from 108 patients prospectively selected from gastroenterology departments of five French hospital centers. These patients were infected (45) or uninfected (47) by H . pylori, or had doubtful results (16), according to the gold standard (culture or histology plus rapid urease test or urea breath test). The tests were evaluated by determining the usual parameters of performance: sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. Two analyzes were performed including or not the 16 patients with doubtful infection as uninfected or not analyzed. Results Depending on the type of analysis, four or two of the 17 enzyme‐linked immunosorbent assay tests presented excellent results with the five performance parameters >90%. Calculation of the Y ouden index allowed to show significantly better performances for one of the 4. Performances of the 12 near‐patient tests were lower with accuracies <90% for all except one test. Conclusion These data should help the users to choose the kit the most appropriate to their goals.