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Evaluation of five commercial serological tests for the detection of Helicobacter pylori infection in Chinese
Author(s) -
Szeto M. L.,
Lee C. K.,
Yee Y. K.,
Li K. F.,
Lee W. K.,
Lee C. C.,
Que T. L.,
Wong B. C. Y.
Publication year - 2001
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2001.00961.x
Subject(s) - serology , helicobacter pylori , medicine , gold standard (test) , gastroenterology , population , spirillaceae , helicobacter pylori infection , antibody , diagnostic accuracy , chinese population , immunology , gastritis , biology , environmental health , biochemistry , genotype , gene
Background: Commercial serological tests for the detection of Helicobacter pylori infection must be locally validated. We evaluated the accuracy of five commercial tests in the Chinese population. Methods: Serum samples were collected from patients referred for upper endoscopy. Antral biopsies were taken for histological examination and culture of H. pylori . The gold standard for diagnosing H. pylori infection was positive histological staining and/or positive H. pylori culture. The serum samples were tested for H. pylori antibodies using the following tests: (i) Cobas Core Anti‐ H. pylori EIA; (ii) GAP IgG; (iii) GAP IgM; (iv) H. pylori microwell EIA (Quidel); and (v) Premier H. pylori . The sensitivity, specificity and accuracy of each test was calculated according to the manufacturers’ instructions or according to a new cut‐off value. Results: A total of 158 patients were recruited amongst whom 114 (72%) were H. pylori ‐positive. Indeterminate results varied from 7% to 19%. The accuracy of the tests varied from 57% to 85%. By using new cut‐off values, the accuracy was much improved, ranging from 73.4% to 86.7%. Conclusions: By defining new cut‐off values for the Chinese population, we were able to improve the performance of some of the serology tests. This illustrates the importance of local validation.