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Mobidiag Bacterial Gastroenteritis Assay Gets CE Mark

NEW YORK (GenomeWeb) — Finnish molecular diagnostics firm Mobidiag said today that its Amplidiag Bacterial GE assay has received CE IVD marking and is now commercially available in Europe.

Amplidiag Bacterial GE is an in vitro diagnostic test indicated to aid in the diagnosis of patients suspected of bacterial gastroenteritis. It uses qPCR to rapidly and qualitatively detect in stool samples eight gastroenteritis-causing bacteria: Campylobacter; Salmonella; Shigella/enteroinvasive Escherichia coli; Yersinia; and enterohemorrhagic, enteropathogenic, enteroaggregative, and enterotoxigenic E. coli.

The test provides same-day results that should be used in conjunction with other clinical and laboratory findings.

CE marking follows the successful completion of a two-center performance evaluation study of 1,235 patient samples and 125 spiked samples, with the test showing an overall sensitivity of 99.0 percent and specificity of 99.9 percent when compared with routine stool culture and independent nucleic acid-based methods, Mobidiag said.

In 2013, Espoo-based Mobidiag successfully completed a three-way merger with Genewave and Amplidiag, solidifying its position in the field of molecular diagnostics.