BioMérieux, a world leader in the field of in-vitro diagnostics, today announced that the BIO FIRE Respiratory Panel 2.1 plus (RP2.1plus) is CE marked. The BIO FIRE Respiratory Panel 2.1 plus (RP2.1plus) tests for 23 pathogens (19 viruses, including SARS-CoV-2, and 4 bacteria) responsible for the most frequent respiratory tract infections. It will be commercially available in all countries that recognize CE marking from now on or shortly thereafter.
The BIO FIRE RP2.1plus advances the existing BIO FIRE Respiratory Panel 2 plus (RP2plus) by adding SARS-CoV-2 to the panel menu while maintaining an assay runtime of about 45 minutes. The BIO FIRE RP2.1plus panel also includes an assay for the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). This new panel allows healthcare providers to quickly identify patients with common respiratory pathogens and differentiate those with COVID-19, using one single test. The BIOFIRERP2.1plus runs on the fully automated BIO FIRE FILMARRAY 2.0 and BIO FIRE FILMARRAY TORCH systems and is extremely easy to use.
“The availability of BIO FIRE RP2.1plus in all countries recognizing CE marking represents a global syndromic response to this unprecedented COVID-19 pandemic,” said Pierre Boulud, Chief Operating Officer, Executive Vice President, Clinical Operations at bioMérieux. “With increasing reagent production capacity and an installed base of more than 14 000 BIO FIRE units throughout the world.
BIO FIRE RP2.1plus will play a key role now and in the upcoming respiratory season as healthcare providers face the regular group of respiratory pathogens as well as SARS-CoV-2”, he added. The BIO FIRE RP2.1plus Panel is part of a suite of products in response to the COVID – 19 pandemic. The ARGENE SARS-CoV-2 R-GENE was launched in March 2020, followed by the U.S. FDA EUA cleared BIO FIRE RP2.1 panel and the VIDAS antiSARS- CoV-2 IgM and anti-SARS-CoV-2 IgG tests. These complementary tests help meet the varying needs of bioMérieux’s diverse customers and patients throughout the world.
The BIO FIRE solution is a U.S. FDA-cleared and CE-marked multiplex PCR closed and fully automated system that integrates sample preparation, amplification, and detection.
A BIO FIRE test requires only two minutes of hands-on time and has a total run time of about 45 to 75 minutes, depending on the panel. The BIO FIRE range has the largest infectious disease pathogen menu commercially available composed of:
- BIO FIRE Respiratory Panels (RP, RP2, RP2plus, RP2.1, and RP2.1plus), identifying between 20 and 23 respiratory viruses and bacteria performed directly on nasopharyngeal swabs in transport media.
- BIO FIRE COVID-19 test detects SARS-CoV-2 in approximately 45 minutes from a nasopharyngeal swab in transport media.