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Clinical Chemistry 44: 293-298, 1998;
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(Clinical Chemistry. 1998;44:293-298.)
© 1998 American Association for Clinical Chemistry, Inc.

Immunology

Development of FlexSure® HP—an immunochromatographic method to detect antibodies against Helicobacter pylori

Wayne H. Schrier, Ronald J. Schoengolda, Josefina T. Baker, Joyce L. Norell, Corey L. Jaseph, Yelena Okin, Jeam Y. Doe, and Howard Chandler1

1 176A Princess Point Rd., Yarmouth, ME 04103.
a Author for correspondence. Fax 415-845-3540;

We describe a solid-phase immunochromatographic serologic test, FlexSure® HP, to detect IgG antibodies against Helicobacter pylori. H. pylori colonize the stomach and proximal duodenum, cause ulcer disease and mucosa-associated lymphoid tissue lymphoma, and have a role in the development of other disorders, including gastric adenocarcinoma. FlexSure 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. pylori. The reactive cutoff of the test was consistent with [13C]urea breath test and commercially available ELISAs. FlexSure HP had 94% sensitivity, 88% specificity, and 91% accuracy relative to [13C]urea breath test; and 95% sensitivity, 94% specificity, and 95% overall agreement relative to high-molecular-mass cell-associated protein enzyme immunoassay (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.




The following articles in journals at HighWire Press have cited this article:


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A. H. Peruski and L. F. Peruski Jr.
Immunological Methods for Detection and Identification of Infectious Disease and Biological Warfare Agents
Clin. Vaccine Immunol., July 1, 2003; 10(4): 506 - 513.
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W. K. Leung, F. K. L. Chan, M. S. Falk, R. Suen, and J. J. Y. Sung
Comparison of Two Rapid Whole-Blood Tests for Helicobacter pylori Infection in Chinese Patients
J. Clin. Microbiol., November 1, 1998; 36(11): 3441 - 3442.
[Abstract] [Full Text]


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