Fast and Accurate PCR-Based Diagnostics of Gastroenteritis

Mobidiag Ltd, a Finnish molecular diagnostics company specialised in the development of innovative diagnostics solutions for infectious diseases, have announced the European launch of Amplidiag™ Bacterial GE, marketed as a CE-IVD product under the Directive 98/79/EC on in vitro diagnostic medical devices. CE marking follows the successful completion of a two-centre performance evaluation study. The test optimises stool sample screening processes by utilising well-established qPCR technology for rapid qualitative detection of eight gastroenteritis-causing bacteria. In contrast to current routine practices, the test does not require pre-culturing of the sample, bringing both laboratory process benefits by substantially reduced need for cultures, as well as clinical benefits by providing early, clinically relevant information. The test’s rapid and comprehensive results enable timely, evidence-based patient management decisions, contributing to improved healthcare processes.

Amplidiag™ Bacterial GE has been validated with 1235 patient samples and 125 spiked samples in a two-centre 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.