First BfArM Listed COVID-19 Pool Test to be approved by the Paul-Ehrlich-Institut (PEI). Test can screen up to five individuals suspected of COVID-19 or up to 5 asymptomatic individuals.
LumiraDx, a next-generation point of care (POC) diagnostics testing company, has announced the official commercial launch of its SARS-CoV-2 Ag Pool Test in Europe.
The test supports screening programmes in settings including events, workplace, school and travel, reducing unnecessary disruptions while ensuring the health of groups.
The test received CE mark earlier this spring with limited availability and is now commercially available across Europe.
This the first time the PEI has approved a pool test from the BfArM List, which now makes LumiraDx’s SARS-CoV-2 Ag Pool Test the only pool test eligible for reimbursement.
Used with the LumiraDx Platform, the test offers a rapid, scalable and cost-effective screening solution for infectious individuals.
David Walton, LumiraDx chief commercial officer, explained: “Whether it’s a football match, concert, or the theatre, screening groups is an important part in safely resuming large gatherings, giving attendees ease of mind, and serves as a critical tool for us to contain the spread of this virus and its new variants.
“The ability to test five individuals simultaneously makes the SARS-CoV-2 Ag Pool Test an efficient, accurate and economical way to implement a high-quality and thorough screening programme.”
Pilot customers in Italy and Germany, including Corona Test Station Berlin (CTSB), have already used the SARS-CoV-2 Ag Pool Test for sporting events, museum entry and festivals.
Arne Fritsche with CTSB commented: “LumiraDx’s SARS-CoV-2 Ag Pool Test has helped us to provide reliable and highly accurate testing and optimise the attendee process at events, such as currently for the Berlinale Summer Special, Berlin Philharmonic concert at Waldbühne Berlin, ALBA Basketball matches at Mercedes Benz Arena Berlin and for the Handball matches of Berliner Füchse at Max Schmeling Halle Berlin.
“Testing takes place either decentrally at the various CTSB testing stations or mobile at the event locations before entering the event. Attendees receive a digital notification of their test result after just a few minutes and can then enter the venue with a negative test result.
“In this way, we achieve maximum safety for the health of all those present as well as a fast and uncomplicated admission situation.”
In clinical studies, the LumiraDx SARS-CoV-2 antigen pool test demonstrated 100 per cent positive agreement and 96.6 per cent negative agreement when compared to testing individual swabs on the LumiraDx SARS-COV-2 Ag Test.
The LumiraDx SARS-CoV-2 Ag Test is a high sensitivity antigen test that combines high performance and speed to an actionable result. In clinical studies, it demonstrated a 97.6 per cent positive agreement and 96.6 per cent negative agreement with RT-PCR in patients within 12 days of symptom onset.
Pooling testing has been shown to significantly reduce resources, including tests, operators, ad instruments, required on a per-patient basis.
In addition, as up to five swabs may be tested simultaneously, testing time is reduced as much as 60 per cent allowing for efficient and seamless entry protocols in large venues and other group settings.