Mobidiag Announces CE-IVD Marking of Amplidiag™ Bacterial GE
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Mobidiag Ltd has 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-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. 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-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.
Changing scenery of bacterial gastroenteritis
Diarrhea is usually a symptom of gastroenteritis, i.e. infection in the intestinal tract caused by bacterial, viral or parasitic organisms. Every year, there are an estimated 1.7 billion cases of diarrheal disease globally. Bacterial pathogens are responsible for up to 80% of gastroenteritis cases, especially in traveler’s diarrhea. The most common routine microbiological examination for bacterial gastroenteritis, stool culture, is labor-intensive and usually gives a definitive result only after 1–3 days, but may require up to 7 days.
Stool culture is primarily used to identify pathogenic Campylobacter, Salmonella, Shigella and Yersinia species. However, recent studies with modern PCR methods have shown that a majority of enteric infections are caused by certain diarrheagenic E. coli strains. Enteropathogenic E. coli (EPEC), Enteroaggregative E. coli (EAEC) and enterotoxigenic E. coli (ETEC) have been shown to be the most frequent causative agents in traveler’s diarrhea, with a high prevalence of multi-infections. Enterohemorrhagic E. coli (EHEC) is one of the most important detectable pathogens in terms of patient management decisions.
Amplidiag™ Bacterial GE - Innovation from Finland
Amplidiag™ Bacterial GE is an in vitro diagnostic test indicated to aid in the diagnosis of patients suspected of bacterial gastroenteritis. Used as a screening test for stool samples, Amplidiag™ Bacterial GE gives substantial laboratory process benefits and clinical advantages.
The test is able to 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.
