Finnish molecular diagnostics company Mobidiag launches test for PCR-based diagnostics of gastroenteritis.
The company announced on September 23 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. The test optimizes stool sample screening processes by utilizing qPCR technology for detection of eight gastroenteritis-causing bacteria.
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.