Efficacy of a novel, multiplex, real-time PCR kit for the detection of Helicobacter pylori and clarithromycin resistance

Yavas, Ahmet Murat; Acikgoz, Ziya Cibali; Hizli, Samil; Dereci, Selim; Duran, Fatih; Yildirim, Fatma; Demir, Pervin

doi:10.21608/mid.2024.287075.1930

Efficacy of a novel, multiplex, real-time PCR kit for the detection of Helicobacter pylori and clarithromycin resistance

Document Type : Original Article

Authors

¹ Ankara Yıldırım Beyazıt University, Faculty of Medicine, Medical Microbiology Department, Üniversiteler Mah. İhsan Doğramacı Bulvarı, Ankara Şehir Hastanesi Yanı, 06800 Bilkent/ Çankaya/Ankara/ TÜRKİYE

² Ankara Yıldırım Beyazıt University, Faculty of Medicine, Pediatric gastroenterology department Üniversiteler Mah. İhsan Doğramacı Bulvarı, Ankara Şehir Hastanesi Yanı, 06800 Bilkent/ Çankaya/Ankara/ TÜRKİYE

³ The University of Health Sciences, Gülhane Faculty of Medicine, Pediatric Gastroenterology Department. Emrah Mah. 06018 Etlik/Keçiören/Ankara, TÜRKİYE

⁴ T.R. Ministry of Health, Ankara Bilkent City Hospital, Pediatric Gastroenterology Clinic. Üniversiteler Mahallesi 1604. Cadde No: 9 Çankaya/ANKARA Ankara, TÜRKİYE

⁵ T.R. Ministry of Health, Ankara Bilkent City Hospital, Clinical Pathology Clinic. Üniversiteler Mahallesi 1604. Cadde No: 9 Çankaya/ANKARA Ankara, TÜRKİYE

⁶ Ankara Yıldırım Beyazıt University, Faculty of Medicine, Biostatistics Department, Üniversiteler Mah. İhsan Doğramacı Bulvarı, Ankara Şehir Hastanesi Yanı, 06800 Bilkent/ Çankaya/Ankara/ TÜRKİYE

10.21608/mid.2024.287075.1930

Abstract

Helicobacter pylori is a pathogen involved in the etiopathogenesis of gastroduodenal infections and some gastric malignancies. Accurate diagnosis and rapid detection of antibiotic resistance are crucial for effective treatment.
In this study, we investigated the efficacy of a novel, multiplex, real-time PCR (qPCR) kit (DiaRD-HPykl, Diagen, Turkey) to detect H. pylori on 181 gastric biopsy specimens and simultaneously search clarithromycin resistance. qPCR results obtained from 49 fresh and 132 paraffinized gastric biopsy specimens were compared with histopathologic examination (HPE).
qPCR was positive in 89.2% and 74.2% of the fresh and paraffinized samples with HPE positive result, respectively. These values were 41.7% and 5.7% for HPE negative samples. The overall agreement between HPE and qPCR was 80.1% and the Kappa coefficient of agreement was 0.551. In fresh tissues, the actual agreement was 81.6% and the Kappa value was 0.489, while in paraffinized tissues, these values were 79.6% and 0.566, respectively. Clarithromycin resistance was detected in 12.5% of 112 samples, which were H. pylori positive by qPCR.
In conclusion, the DiaRD-Hpykl qPCR kit, which is resulted in two hours, can be used in combination with HPE or alone as an alternative test for rapid diagnosis and accurate management of treatment.

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