Abstract

Purpose: Diagnosing and treating H. Pylori infection is important for the management of peptic ulcer disease and gastric cancer. The purpose of this study is to compare the sensitivity and effects of H. Pylori detection by pathology and by HP MPCR. Methods: Between March 2011 and Oct 2014 in a clinical practice in New Jersey, 6943 patients suspected of having an H. Pylori infection underwent gastroscopy with biopsies.When the pathology was negative for H. Pylori, the specimen was tested for H. Pylori by HP MPCR from TZAM Diagnostics. The positive results recorded during the specified time period were grouped into the following categories: Pathology (the positive results determined only by pathology), HP MPCR (the positive results determined only by HP MPCR), and Total Positive (the total number of positive results determined by both methods). Results: Out of the 6943 patients, 2456 (35%) total patients tested positive for H. Pylori: 14% (1001) by pathology and 21% (1455) by HP MPCR. Furthermore, all three result categories Pathology, HP MPCR, and Total Positive reveal a decline in the incidence of H. Pylori infection from 2011 to 2014. The incidence of H. Pylori by pathology decreased from 15.8% in 2011 to 13.5% in 2014 (r = -0.891) at a rate of -0.89% per year. The incidence of H. Pylori by HP MPCR decreased from 30.3% in 2011 to 14.0% in 2014 (r = -0.978) at a rate of -5.4% per year. The total incidence of infection (taking both pathology and HP MPCR results into account) decreased from 46.1% in 2011 to 27.6% in 2014 (r= -0.975) at a rate of -6.3% per year (Figure 1). Conclusion: The data demonstrates that HP MPCR is useful in tandem with pathological detection, capturing an additional 21% of the study's population. Assuming a fixed patient population, the incidence of H. Pylori appears to be declining in this clinical practice. However, detection by HP MPCR indicates a much sharper decline in the incidence of H. Pylori infection (-5.4% per year) than detection by pathology (-0.89%). This trend can potentially be explained by the accuracy of HP MPCR detection. Because HP MPCR captures infected patients in addition to those captured by pathological examination, more patients can be treated for the infection, contributing to a general decline in positive H. Pylori cases. The data analysis of this population suggests that utilizing HP MPCR is a potential step toward the eradication of H. Pylori infection.

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