www.fdanews.com/articles/207337-seegenes-allplex-respiratory-virus-assay-gains-ce-ivd-mark
Seegene's Allplex Respiratory Virus Assay Gains CE-IVD Mark
April 11, 2022
South Korea-based Seegene’s Allplex RV Master assay for respiratory viruses has received a CE-IVD mark.
The test can identify 19 different respiratory viruses, including COVID-19, influenza, respiratory syncytial virus (RSV), adenovirus and human rhinovirus, enabling healthcare professionals to quickly find out from a single sample which viruses are making the patient sick.
The assay can identify three genes of COVID-19, Flu A, Flu B, metapneumovirus, two types of RSV, four types of parainfluenza virus, six types of adenovirus and three types of human rhinovirus.
A recent independent clinical test of the assay in Europe with 1,928 participants found that 16.5 percent (318 people) tested positive for respiratory viruses, excluding COVID-19.