PCR-Based Gastroenteritis Diagnostic Assay Receives European Marketing Approval

A PCR-based test that optimizes screening of gastroenteritis-causing bacteria directly from stool samples has been certified for marketing in Europe as a CE-IVD product according to Directive 98/79/EC regarding in vitro diagnostic medical devices.

The Mobidiag Ltd. (Espoo, Finland) Amplidiag Bacterial GE test utilizes well-established qPCR (quantitative polymerase chain reaction) technology for the rapid qualitative detection of eight gastroenteritis-causing bacteria directly from stool samples without requiring pre-culturing of the samples.

Amplidiag Bacterial GE rapidly detects eight of the most common and important enteric bacterial pathogens with a single assay carried out on DNA extracted from the same stool sample and enables same-day reporting of results. In addition to Campylobacter, Salmonella, Shigella/EIEC, and Yersinia, the test also detects the diarrheagenic E. coli strains: enteropathogenic E. coli (EPEC), enteroaggregative E. coli (EAEC), enterohemorrhagic E. coli (EHEC) and enterotoxigenic E. coli (ETEC).

Amplidiag Bacterial GE was validated by assaying 1,235 patient samples and 125 spiked samples in a two-center performance evaluation study conducted in Sweden and Finland. The results showed an overall sensitivity of 99.0% and specificity of 99.9%, when compared with routine stool culture and independent nucleic acid-based methods. Amplidiag Bacterial GE did not give any false negative findings when results were compared with stool culture.

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