Evaluation of a new immunochromatographic test for Helicobacter pylori IgG antibodies in elderly symptomatic patients |
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Authors: | Haim Shirin Rafael Bruck Gabriel Kenet Zipora Krepel Yoram Wardi Simon Reif Liliana Zaidel Dikla Geva Yona Avni Zamir Halpern |
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Institution: | (1) Department of Gastroenterology, The E. Wolfson Medical Center, Holon, and the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel, IL;(2) Department of Pathology, The E. Wolfson Medical Center, Tel-Aviv, Israel, IL;(3) Department of Biostatistics, The E. Wolfson Medical Center, Tel-Aviv, Israel, IL |
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Abstract: | Aim: To determine the diagnostic value of a new serum and whole blood serological IgG antibody test, FlexPack HP, for the
diagnosis of Helicobacter pylori in elderly symptomatic patients.
Methods: 94 consecutive symptomatic patients who underwent upper endoscopy were studied (mean age, 62.6 years). On endoscopy,
the presence of H. pylori infection was examined by biopsies from gastric antrum and body for rapid urease test and histologic examination. Blood was
drawn prior to endoscopy and both blood and serum were immediately analyzed for human IgG antibodies to H. pylori by a new commercially available qualitative immunochromatographic method, FlexPack HP. This test incorporates high-molecular
weight cell-associated proteins (HM-CAP), which are highly specific for H. pylori IgG antibodies.
Results: Overall agreement for FlexPack HP whole blood vs FlexPack HP serum was 100%, and agreement with biopsy results was
71%. The gold standard (detection of H. pylori by histology or urease test) identified H. pylori in 61 patients (65%). Complete agreement was observed between the gold standard test and the serology kit in 72% (68/94)
of sera (51 positive and 17 negative). Disagreement was found in sera of 26 patients; 16 sera were negative by the gold standard
and positive by FlexPack HP and 10 patients were found negative by serology. The sensitivity of FlexPack HP was 84% and the
specificity 52% when compared with the gold standard.
Conclusions: FlexPack HP serum and whole blood test is a simple and reliable method for the detection of H. pylori antibodies, with 100% agreement between the serum and blood results. In the elderly symptomatic patients the sensitivity
of FlexPack HP was similar to that of other serologic tests, but the specificity was relatively low, limiting its use in this
population.
(Received Jan. 7, 1998; accepted Aug. 28, 1998) |
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Keywords: | :H pylori urease test serology elderly |
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