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Evaluation of the FlexSure HP whole blood antibody test for diagnosis ofHelicobacter pyloriinfection

Sadowski, Daniel, MD1; Cohen, Hartley, MD2; Laine, Loren, MD2; Greenberg, Paul, MD3; Goldstein, Jay, MD4; Mihalov, Michael, MD4; Cutler, Alan F, MD5,*

American Journal of Gastroenterology: November 1998 - Volume 93 - Issue 11 - p 2119–2123
doi: 10.1111/j.1572-0241.1998.00604.x
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Objective: Rapid, inexpensive, reliable tests are needed to facilitate the diagnosis of Helicobacter pylori infection. We evaluated the accuracy of the new FlexSure HP whole blood test (SmithKline Diagnostics, Inc.), a rapid, qualitative in-office test for the detection of antibodies to H. pylori utilizing whole blood obtained from a fingerstick.

Methods: Five North American sites enrolled patients not previously treated for H. pylori who underwent upper endoscopy. Patients had not received antibiotics, bismuth, or proton pump inhibitors within 4 wk before study enrollment. Bacterial infection was established by the presence of H. pylori in gastric biopsies (minimum of two) or positive rapid urease test of antral tissue. The presence of IgG antibodies was determined using FlexSure HP whole blood tests with blood obtained by fingerstick and FlexSure HP serum and ELISA (HM-CAP) tests with serum obtained from venipuncture.

Results: Three hundred ninety-three patients were enrolled (56% male; mean age, 46.8 ± 16.0 yr). H. pylori infection was present in 187 (48%). Compared with the standard of histology and rapid urease test, sensitivity for FlexSure HP whole blood, FlexSure HP serum, and HM-CAP EIA were, respectively, 84%, 90%, and 95% (p < 0.05 compared with FlexSure HP whole blood). There were no statistical differences in specificity or overall accuracy between the three tests.

Conclusions: FlexSure HP whole blood demonstrated an accuracy not significantly different from the FlexSure HP serum test but had sensitivity significantly lower than the HM-CAP EIA. FlexSure HP whole blood may be useful for in-office H. pylori diagnosis.

1Department of Medicine, University of Alberta, Edmonton, Canada

2Department of Medicine, University of Southern California, Los Angeles, California, USA

3Department of Medicine University of California San Francisco, San Francisco, California, USA

4Department of Medicine University of Illinois at Chicago, Chicago, Illinois, USA

5Department of Medicine, Sinai Hospital, Detroit, Michigan, USA

*Section of Gastroenterology, Sinai Hospital, 6767 West Outer Drive, Detroit, Michigan 48235

© The American College of Gastroenterology 1998. All Rights Reserved.
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