Molecular diagnosis of Helicobacter pylori infection in gastric biopsies: Evaluation of the Amplidiag®H. pylori + ClariR assay

Hays, Constantin; Delerue, Thibault; Lamarque, Dominique; Burucoa, Christophe; Collobert, Gislène; Billöet, Annick; Kalach, Nicolas; Raymond, Josette

doi:10.1111/hel.12560

Cited by 30 publications

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References 30 publications

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“…glmM PCR. To detect H. pylori infection, a TaqMan real-time PCR assay targeting the H. pylori-specific gene glmM was used, optimizing published methods (27)(28)(29).…”

Section: Methodsmentioning

confidence: 99%

“…Mobidiag (Espoo, Finland) recently developed a new multiplex real-time PCR assay (Amplidiag H. pyloriϩClariR), CE-IVD marketed, detecting H. pylori infection and mutations conferring clarithromycin resistance (without the distinction of the mutations). With good performances when performed on gastric biopsy samples, this test can also be performed on stool specimens (26,27).…”

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confidence: 99%

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Diagnostic Accuracy of a Noninvasive Test for Detection of Helicobacter pylori and Resistance to Clarithromycin in Stool by the Amplidiag H. pylori+ClariR Real-Time PCR Assay

et al. 2020

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The noninvasive detection of Helicobacter pylori and its resistance to clarithromycin could revolutionize the management of H. pylori-infected patients by tailoring eradication treatment without any need for endoscopy when histology is not necessary. Several real-time PCR tests performed on stools have been proposed, but their performances were either poor or they were tested on too few patients to be properly evaluated. We conducted a prospective, multicenter study including 1,200 adult patients who were addressed for gastroduodenal endoscopy with gastric biopsies and who were naive for eradication treatment in order to evaluate the performance of the Amplidiag H. pylori+ClariR assay recently developed by Mobidiag (Espoo, Finland). The results of the Amplidiag H. pylori+ClariR assay performed on DNA from stools (automatic extraction with the EasyMag system [bioMérieux]) were compared with those of culture/Etest and quadruplex real-time PCRs performed on two gastric biopsy samples (from the antrum and corpus) to detect the H. pylori glmM gene and mutations in the 23S rRNA genes conferring clarithromycin resistance. The sensitivity and specificity of the detection of H. pylori were 96.3% (95% confidence interval [CI], 92 to 98%) and 98.7% (95% CI, 97 to 99%), respectively. The positive and negative predictive values were evaluated to be 92.2% (95% CI, 92 to 98%) and 99.3% (95% CI, 98 to 99%), respectively. In this cohort, 160 patients (14.7%) were found to be infected (positive by culture and/or PCR). The sensitivity and specificity for detecting resistance to clarithromycin were 100% (95% CI, 88 to 100%) and 98.4% (95% CI, 94 to 99%), respectively.

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“…glmM PCR. To detect H. pylori infection, a TaqMan real-time PCR assay targeting the H. pylori-specific gene glmM was used, optimizing published methods (27)(28)(29).…”

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

Diagnostic Accuracy of a Noninvasive Test for Detection of Helicobacter pylori and Resistance to Clarithromycin in Stool by the Amplidiag H. pylori+ClariR Real-Time PCR Assay

et al. 2020

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“…28 Partitioning of a PCR solution in thousands of small-volume samples within oil droplets by the droplet digital PCR (ddPCR) technique allows for absolute quantitation of target sequences and possibly higher sensitivity than real-time PCR for the detection of low-quantity genotypes in mixed populations. Information on clarithromycin resistance is of utmost importance for choosing an appropriate first-line eradication therapy thus beneficially affecting the therapy's success.…”

Section: Molecular Methodsmentioning

confidence: 99%

Review: Diagnosis of Helicobacter pylori infection

et al. 2019

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Endoscopic imaging of the stomach is improving. In addition to narrow band imaging, other methods, for example, blue light imaging and linked color imaging, are now available and can be combined with artificial intelligence systems to obtain information on the gastric mucosa and detect early gastric cancer. Immunohistochemistry is only recommended as an ancillary stain in case of chronic active gastritis without Helicobacter pylori detection by standard staining, and recommendations to exclude false negative H. pylori results have been made. Molecular methods using real‐time PCR, droplet digital PCR, or amplification refractory mutation system PCR have shown a high accuracy, both for detecting H. pylori and for clarithromycin susceptibility testing, and can now be used in clinical practice for targeted therapy. The most reliable non‐invasive test remains the 13C‐urea breath test. Large data sets show that DOB values are higher in women and that the cut‐off for positivity could be decreased to 2.74 DOB. Stool antigen tests using monoclonal antibodies are widely used and may be a good alternative to UBT, particularly in countries with a high prevalence of H. pylori infection. Attempts to improve serology by looking at specific immunodominant antigens to distinguish current and past infection have been made. The interest of Gastropanel® which also tests pepsinogen levels was confirmed.

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“…In addition to high sensitivity, molecular methods have other advantages. For example, real-time PCR 29 or dd-PCR with specific primers is able to detect various H. pylori strains in gastric or stool samples by genotyping of antibiotic resistance genes (23S rRNA, gyrA, 16S rRNA, rpoB, pbp-1a), 30,31 virulence genes (cagA, vacA, dupA), 32 and even the polymorphisms of human CYP2C19 gene 33 which is important in anti-H. pylori therapy efficacy. 34 This will then aid the choice of an appropriate treatment strategy targeting strains with different susceptibility and virulence profiles.…”

Section: Genotyping Antibiotic Resistance and Quantitative Microbiome Studymentioning

confidence: 99%

Application of molecular techniques inHelicobacter pyloridetection: limitations and improvements

Gong

El‐Omar

2021

Helicobacter

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Application of molecular techniques in Helicobacter pylori detection: limitations and improvements 1 | INTRODUC TI ONHelicobacter pylori (H. pylori), a microaerophilic gram-negative proteobacterium, is the most common human pathogen colonizing the gastric mucosa of over half the world's population. 1,2 Although 70% of infected people are symptomless, H. pylori is recognized as a strong causative factor in many gastrointestinal (GI) diseases such as peptic ulcer, atrophic gastritis, gastric cancer, and mucosa-associated lymphoid tissue (MALT) lymphoma. 3 The transmission of H. pylori is usually through person-to-person contact or from environmental sources via oral-oral, fecal-oral, and gastro-oral routes. 4 Therefore, its infection rate is linked to familial socioeconomic status, overcrowding, poor hygiene, and environmental contamination in food and water supply. 5 While maintaining a spiral rod-shaped form in a favorable environment, H. pylori may transform into coccoid shape, a viable but non-culturable (VBNC) form with low metabolic activity, to survive under stressful conditions including oxygen deprivation, antibiotic exposure, and epithelial attachment. 6 Treatment of the infection is usually a combination of acid inhibitory agents (eg, Proton Pump Inhibitors PPI) and antibiotics (ie, amoxicillin, clarithromycin, metronidazole, and tetracycline), the choice of which depends on antibiotic sensitivity. 7 Efficient diagnosis is required for successful clinical management to relieve symptoms and to eradicate bacteria. Clinicians have developed numerous H. pylori detection methods, which are divided into two groups based on whether samples are collected by invasive endoscopy. 8 Serology, urea breath test (UBT), and stool antigen test (SAT) are the non-invasive tests carried out on stool, breath, saliva, or serum samples. 9 The invasive tests including endoscopy, histology, culture, and rapid urease test (RUT) are carried out on gastric biopsies. 10 All these conventional tests are based on the presence of different components such as enzymes (UBT, RUT), antigens (SAT), bacteria (culture), and antibodies (serology, histology). 11 Several reviews have discussed their advantages and disadvantages in accuracy, sensitivity, specificity, simplicity, and cost. [12][13][14][15] To improve conventional methods, especially sensitivity, some molecular techniques based on DNA/RNA have been recently used in both invasive and non-invasive H. pylori diagnosis. 16 These new methods include polymerase chain reaction (PCR), 17 real-time PCR, 18 droplet digital PCR (dd-PCR), 19 fluorescent in situ hybridization (FISH), 20 and next-generation sequencing (NGS) including 16S rRNA amplicon sequencing, 16 transcriptomics, 21 and metagenomics. 22 In this issue, Gantuta et al. 23 discussed the advantages of 16S rRNA sequencing in H. pylori diagnosis, which brings to attention the need to review molecular detection tests, especially their shortcomings. This editorial summarizes our current understanding of molecular methods, focusing on ...

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Molecular diagnosis of Helicobacter pylori infection in gastric biopsies: Evaluation of the Amplidiag^®H. pylori + ClariR assay

Cited by 30 publications

References 30 publications

Diagnostic Accuracy of a Noninvasive Test for Detection of Helicobacter pylori and Resistance to Clarithromycin in Stool by the Amplidiag H. pylori+ClariR Real-Time PCR Assay

Diagnostic Accuracy of a Noninvasive Test for Detection of Helicobacter pylori and Resistance to Clarithromycin in Stool by the Amplidiag H. pylori+ClariR Real-Time PCR Assay

Review: Diagnosis of Helicobacter pylori infection

Application of molecular techniques inHelicobacter pyloridetection: limitations and improvements

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