Wh. Schrier et al., DEVELOPMENT OF FLEXSURE(R) HP - AN IMMUNOCHROMATOGRAPHIC METHOD TO DETECT ANTIBODIES AGAINST HELICOBACTER-PYLORI, Clinical chemistry, 44(2), 1998, pp. 293-298
We describe a solid-phase immunochromatographic serologic test, FlexSu
re(R) HP, to detect IgG antibodies against Helicobacter pylori. H. pyl
ori colonize the stomach and proximal duodenum, cause ulcer disease an
d mucosa-associated lymphoid tissue lymphoma, and have a role in the d
evelopment of other disorders, including gastric adenocarcinoma. FlexS
ure HP consists of a test strip, conjugate pad, and absorbent pad, in
a novel reverse-flow chromatography format. In these studies, FlexSure
HP was demonstrated to be specific for IgG antibodies against H. pylo
ri. The reactive cutoff of the test was consistent with [C-13]urea bre
ath test and commercially available ELISAs. FlexSure HP had 94% sensit
ivity, 88% specificity, and 91% accuracy relative to [C-13]urea breath
test; and 95% sensitivity, 94% specificity, and 95% overall agreement
relative to high-molecular-mass cell-associated protein enzyme immuno
assay (HM-CAP EIA). FlexSure HP is a simple-to-perform, visually read
test requiring no specialized training, equipment, or instrumentation,
and yields rapid, accurate, qualitative results.