A diagnositc accuracy study: comparison of two different molecular based tests (GenoType HelicoDR and Seeplex ClaR-H. pylori ACE detection), in the diagnosis of Helicobacter pylori infections

7th Euroscicon Conference on Clinical Pathology and Epidemiology
February 27-28, 2019 | Prague, Czech Republic

Recep Kesli, Huseyin Bilgin, Yasar Unlu and Gokhan Gungor

Selcuk Universit, Turkey Uludag University, Turkey Sagl├?┬▒k Bilimleri University, Turkey

Posters & Accepted Abstracts: J Infec Dis Treat

DOI: 10.21767/2472-1093-C1-009

Abstract

Aim: The aim of this study was to compare the diagnositc values of two different molecular based tests (GenoType® HelicoDR ve Seeplex® H. pylori-ClaR- ACE Detection) in detection presence of the H. pylori from gastric biopsy specimens. In addition to this, we also aimed to determine resistance ratios of H. pylori strains against to clarytromycine and quinolone isolated from gastric biopsy material cultures by using both the genotypic (GenoType® HelicoDR, Seeplex ® H. pylori -ClaR-ACE Detection) and phenotypic (gradient strip, E-test) methods.

Material & Methods: A total of 266 patients who admitted to Konya Education and Research Hospital, Department of Gastroenterology with dyspeptic complaints, between Jan’ 2011-Jun’ 2013, were included in the study. Microbiological and histopathological examinations of biopsy specimens taken from antrum and corpus regions were performed. The presence of H. pylori in all the biopsy samples was investigated by five differnt dignostic methods together: culture (C) (Portagerm pylori-PORT PYL, Pylori agar-PYL, GENbox microaer, bioMerieux, France), histology (H) (Giemsa, Hematoxylin and Eosin staining), rapid urease test (RUT) (CLOtest, Cimberly-Clark, USA) and two different molecular tests; GenoType® HelicoDR, Hain, Germany, based on DNA strip assay, and Seeplex ® H. pylori -ClaR- ACE Detection, Seegene, South Korea, based on multiplex PCR. Antimicrobial resistance of H. pylori isolates against clarithromycin and levofloxacin was determined by GenoType® HelicoDR, Seeplex ® H. pylori -ClaR- ACE Detection, and gradient strip (E-test, bioMerieux, France) methods. Culture positivity alone or positivities of the both histology and RUT together was accepted as gold standard for H. pylori positivity. Sensitivity and specificity rates of two molecular methods used in the study, were calculated by taking the two gold standards previously mentioned.

Results: A total of 266 patients between 16-83 years old, out of which 144 (54.1%) were female, 122 (45.9%) were male were included in the study. 144 patients were found as culture positive and 157 were H and RUT were positive together. 179 patients were found as positive with GenoType® HelicoDR and Seeplex ® H. pylori -ClaR-ACE Detection together. Sensitivity and specificity rates of studied five different methods were found as fallows: C were 80.9% and 84.4% , H + RUT were 88.2% and 75.4%, GenoType® HelicoDR were 100 % ve 71.3 %, and Seeplex ® H. pylori -ClaR- ACE Detection were, 100% and 71.3%. A strong correlation was found between C and H+RUT, C and GenoType® HelicoDR, and C and Seeplex ® H. pylori-ClaR-ACE Detection (r=0.644 and p=0.000, r=0.757 and p=0.000, r=0.757 and p=0.000, respectiveley). Of all the isolated 144, H. pylori strains, 24 (16.6%) were detected as resistant to clarithromycin and 18 (12.5%) were levofloxacin. Genotypic clarithromycin resistance were detected only in 15 cases with GenoType® HelicoDR and 6 cases with Seeplex ® H. pylori -ClaR- ACE Detection.

Conclusion: In this study it was cocncluded that GenoType® HelicoDR and Seeplex ® H. pylori -ClaR-ACE. Detection was found as the most sensitive diagnostic methods when compared to all the investigated other ones (C, H, and RUT).

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