Test optimizes screening of gastroenteritis-causing bacteria directly from stool samples

Mobidiag Ltd, have launched Amplidiag™ Bacterial GE in Europe, marketed as a CE-IVD product under the Directive 98/79/EC on in vitro diagnostic medical devices. The CE marking follows the successful completion of a two-center performance evaluation study. The test optimizes stool sample screening processes by utilizing well-established qPCR technology for rapid qualitative detection of eight gastroenteritis-causing bacteria.

Used as a screening test for stool samples, Amplidiag™ Bacterial GE gives substantial laboratory process benefits and clinical advantages. No pre-enrichment is needed and the test can detect eight of the most common and important enteric bacterial pathogens rapidly from the same sample with a single assay and enables reporting same-day results. In addition to Campylobacter, Salmonella, Shigella/EIEC, Yersinia, the test also detects EHEC, EPEC, EAEC and ETEC from DNA extracted from a stool sample. The test results are used in conjunction with other clinical and laboratory findings.

Amplidiag™ Bacterial GE has been validated with 1235 patient samples and 125 spiked samples in a two-center performance evaluation study. The study was performed at the Clinical Microbiology Laboratory of Karolinska University Hospital Huddinge in Stockholm, Sweden, and UTULab, the clinical microbiology service laboratory of University of Turku, Faculty of Medicine, in Turku, 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.