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3rd June 2015  Content supplied by: Mobidiag Oy

CE Marking for Novel H. pylori and Clarithromycin Resistance Test

Mobidiag Ltd, have obtained CE-IVD marking of their  Amplidiag™ H. pylori+ClariR test. This qualitative qPCR-based test expands the gastrointestinal Amplidiag test menu and is immediately available throughout Europe. The first-to-market, non-invasive molecular diagnostic test reliably detects the gastric pathogen H. pylori as well as one of its key resistances to clarithromycin. The test is performed directly from stool DNA extract in a rapid manner.

Amplidiag H. pylori+ClariR is aimed at primary testing in cases where H. pylori infection is suspected. Through the unique ability to detect a key antibiotic resistance in conjunction with the pathogen, the test enables the targeting of primary eradication therapy without inconvenient invasive procedures and unnecessary waiting. In the longer term, the test is expected to contribute to the fight against gastric cancers, a global killer consistently associated with H. pylori infection.

The test performance was evaluated with nearly 300 clinical samples and was compared to two commonly used stool antigen tests. All positive findings were further sequenced to verify the result and the correct identification of the clarithromycin resistance gene mutations. The established sensitivity and specificity for H. pylori identification were 93.1% and 99.2%, respectively, while both figures were 100% for clarithromycin resistance mutation detection. Out of the nearly 300 samples, Amplidiag H. pylori+ClariR identified 54 true positive samples, of which 12 were found to have a clarithromycin resistance mutation.

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Date Published: 3rd June 2015

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