Novel Multiplex Assay Allows Reliable Detection of Diarrheal Pathogens

Seegene announced today the publication of an independent retrospective study evaluating the Seeplex® Diarrhea-V ACE (Seeplex® DV) assay. The assay was found to be sensitive, specific, convenient and reliable for the direct detection of multiple enteric viruses in one reaction from patients with gastroenteritis.

Seeplex® DV is a novel commercialized multiplex reverse transcription polymerase chain reaction (RT-PCR) assay capable of simultaneously detecting and differentiating five common viral diarrheal pathogens; adenovirus, rotavirus, norovirus genogroup I (GI) and GII and astrovirus. The assay has been approved for use in more than 30 countries accepting the CE-IVD mark, as well as Health Canada. Many laboratories and hospitals located in around 30 countries, including UK, Germany, France, Spain and Italy, use the product currently. However, the detection kit is not available in the United States and has not yet been cleared for use by the United States Food & Drug Administration.

Viral gastroenteritis outbreaks occur frequently in nursing homes and health care institutions as well as on cruise ships. The incidence of viral induced gastroenteritis has been reported to be on the increase and in certain cases can be associated with increased morbidity and mortality. Acute intestinal infection can be caused by one of several viruses, including adenovirus, rotavirus, norovirus GI and GII or astrovirus.

The authors of the study note that current molecular diagnostic technologies rely on laboratory-developed, or "home brew" tests that are expensive require advanced clinical techniques, and often test for only one infection at a time. The authors add that "the Seeplex® DV assay demonstrates several strengths as a commercial assay for use in a wider range of clinical laboratory settings
outside of a highly resourced centre."