COVID-VIRO® is a rapid test, CE marked, for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasopharyngeal swab samples.
Within 15 minutes, COVID-VIRO® detects the absence or presence of the antigen in the specimen collected at the onset of the first symptoms. It has been validated by an expert laboratory.
A Steering Committee made up of French experts in infectious diseases, pharmacists, virologists and associations is responsible for guiding its evaluation studies, designing the neccessary support tools, considering its place and supporting its launch on the European market.
In France, the recent publication of the decree of September 15th, 2020 authorizes its use by healthcare professionals according to the terms and conditions available here. The test can also be deployed oustide laboratories (pharmacies, doctor’s offices etc.) according to the latest HAS recommendations published on September 25th and October 9th, available here and here.
COVID-VIRO® is on the list of tests authorized by the Ministry of Health.
Box of 20 tests containing:
– 20 sealed pouches each containing 1 test cassette
– 2 vials of buffer
– 20 sterile nasopharyngeal swabs
– 20 extraction tubes and 20 tips with filter
– 1 tube holder
– 1 instruction for use
COVID-VIRO® is a rapid assay for the qualitative detection of SARS-CoV-2 antigen for use by healthcare professionals.
This test is reliable for the detection of SARS-CoV-2 infections during the incubation period that can range from 1 to 14 days but is usually 3 to 7 days.
Read the instructions in the package insert carefully.
Manufactured and distributed by : AAZ-LMB 43 rue de Bellevue 92100 Boulogne-Billancourt, FRANCE
This in vitro diagnostic medical device is a regulated health product which, under these regulations, bears the CE mark.
Internal page reference : AAZ.CV.27-A (created on 2020/10/27) webpage