Point-of-care Helicobacter pylori urine antibody detection in a multi-ethnic adult population in the United States.
A need exists for accurate point-of-care tests for diagnosis of Helicobacter pylori (H. pylori) infection to evaluate a rapid urine-H. pylori antibody test device for detection of H. pylori infection in a point-of-care setting in the United States. A multi-center study in a multi-ethnic population compared the RAPIRUN urine antibody test with the (13)C-urea breath test (C-UBT) and a traditional serologic test, the high-molecular-weight cell-associated protein enzyme immunoassay (HM-CAP EIA). The primary comparator was with "definite positive" and "definite negative" patients defined as a concordance of combined results of the UBT and the HM-CAP IgG EIA. Overall, 188 eligible patients were enrolled (61 men, age range: 18-73 years, including 84 Hispanics, 73 Asian-Pacific Americans, 22 Black African-Americans, 6 non-Hispanic Caucasians, and 3 of "other" ethnicity). Compared with "definite positive" and "definite negative" results, the sensitivity and specificity of the urine antibody test were 0.9 and 1.0, respectively. The urine antibody test proved suitable for point-of-care rapid diagnosis of anti-H. pylori antibodies indicative of active or past H. pylori infection.
Opekun
Antone R
AR
Baylor College of Medicine, Houston, Texas 77030, USA. aopekun@bcm.tmc.edu
Luu
Phong
P
Gotschall
Ann B
AB
Abdalla
Nageeb
N
Torres
Elizabeth
E
Rudd
Summer B
SB
Graham
David Y
DY
Nurgalieva
Zhannat Z
ZZ
Tsuchiya
Kyoko
K
D000293:Adolescent; D000328:Adult; D000368:Aged; D000907:Antibodies, Bacterial / Q000276:immunology / Q000652:urine*; D005006:Ethnicity; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000208:ethnology / Q000276:immunology; D016480:Helicobacter pylori / Q000276:immunology* / Q000302:isolation & purification*; D006801:Humans; D007124:Immunoenzyme Techniques; D007074:Immunoglobulin G / Q000652:urine; D008297:Male; D008507:Medically Underserved Area; D008875:Middle Aged; D019095:Point-of-Care Systems; D011933:Reagent Kits, Diagnostic / Q000382:microbiology; D014481:United States / Q000453:epidemiology
D000907:Antibodies, Bacterial; D007074:Immunoglobulin G; D011933:Reagent Kits, Diagnostic