Detection of serum antibodies to Helicobacter pylori by an immunochromatographic method.
OBJECTIVE
FlexsureHP is a bi-directional immunochromatographic device for detection of IgG antibodies to Helicobacter pylori in human serum. This test, requiring only three steps and a 4-min incubation, can be used as an office-based diagnostic test. The goal of this study was to compare the sensitivity and specificity of the FlexsureHP, when performed by a clinician, with the established ELISA in the evaluation of clinical samples in an office setting.


RESULTS
The sensitivity and specificity of the FlexsureHP, compared with the biopsy, is 92.4% and 83.0%, respectively, with a positive predictive value of 88.4%. This was not significantly different from the results obtained when the ELISA was compared with biopsy data.


CONCLUSIONS
The immunochromatographic device, FlexsureHP, is a rapid, highly sensitive, and moderately specific office-based diagnostic test for H. pylori infection.
Anderson
J C
JC
Department of Medicine, State University of New York at Stony Brook, USA.
Cheng
E
E
Roeske
M
M
Marchildon
P
P
Peacock
J
J
Shaw
R D
RD
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000097:blood*; D002845:Chromatography / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000276:immunology*; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D008875:Middle Aged; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods
D000907:Antibodies, Bacterial; D007074:Immunoglobulin G