NEW YORK ─ LumiraDx on Thursday announced it has obtained CE marking for its five-minute SARS-CoV-2 Ag Ultra Test.
The assay enables users to complete up to 80 SARS-CoV-2 antigen tests per eight-hour day, or up to 10 per hour, on a single LumiraDx instrument, London-based LumiraDx said.
Advances to the design of the test strip on its Ultra test allow higher sample volumes to enter the test strip chambers to increase detection levels, achieve faster reaction times, and enable greater precision, the company said.
"Clinicians, pharmacies, and other providers can use a single platform and significantly increase throughput," LumiraDx CEO Ron Zwanziger said in a statement.
The LumiraDx SARS-CoV-2 Ag Ultra Test has a positive percent agreement of 92.7 percent and a negative percent agreement of 100 percent versus RT-PCR in symptomatic individuals, based on clinical data collected up to 12 days from symptom onset, the firm said.
Within this cohort, the test showed a sensitivity of 97.4 percent up to a cycle threshold of 35 and demonstrated 95.7 percent positive agreement versus RT-PCR in samples collected from asymptomatic individuals, LumiraDx added.