Evaluation of three commercial enzyme-linked immunosorbent assay kits for diagnosis of Helicobacter pylori in Chinese patients.
Most of the commercial serological assays for H. pylori are developed and validated in western countries. We evaluated the accuracy of three popular commercial ELISA tests for H. pylori in the Chinese population. Eighty dyspeptic patients were recruited and diagnosis of H. pylori infection was based on biopsy urease test, histology and urea breath test. Thirty-six patients (45%) were positive for H. pylori infection by two or more positive reference tests. Anti-H. pylori IgG antibody was detected by three commercial ELISA tests: GAP IgG (Bio-Rad), HM-CAP (Enteric Products) and Pyloriset EIA-G (Orion). The respective sensitivity, specificity, positive and negative predictive values of the three tests were: GAP IgG (50%, 97.4%, 93.8%, 71.7%), HM-CAP (72.7%, 68.4%, 66.7%, 74.3%) and Pyloriset EIA-G (75%, 86.4%, 81.8%, 80.9%). Despite the high accuracy reported in the West, the performance of these commercial serological tests was unsatisfactory when used in Chinese patients.
Leung
W K
WK
Department of Medicine and Therapeutics, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, Hong Kong.
Ng
E K
EK
Chan
F K
FK
Chung
S C
SC
Sung
J J
JJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000097:blood*; D002681:China; D004415:Dyspepsia / Q000382:microbiology; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005069:Evaluation Studies as Topic; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000382:microbiology; D016480:Helicobacter pylori / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
D000907:Antibodies, Bacterial; D011933:Reagent Kits, Diagnostic