The Instrument and Test Strips are integrated with several quality control checks to ensure the Instrument and Test are functioning correctly for every test run.
The workflow process is comprised of a simple sample prep along with step-by-step guidance of the Instrument to report a patient result in just 5 minutes from sample application.
In clinical studies, the LumiraDx SARS-CoV-2 Ag Ultra Pool test demonstrated 93.1%* positive agreement versus RT-PCR in samples collected up to and including 12 Days since onset of symptoms.
Refer to SARS-CoV-2 Ag Ultra Product Insert for full clinical data
The following table shows the performance for subsets grouped by Ct value, of the results above, illustrating that the LumiraDx SARS-CoV-2 Ag Ultra Pool test has high sensitivity in patients with a Ct value <34.
Samples with Cts above 33-34 are generally considered to be non-infectious1 indicating that the LumiraDx SARS-CoV-2 Ag Ultra Pool test can verify quickly that COVID-19 isn’t spreading in your population.
|Ct < 33 (all)||28||92.9%||77.4- 98.0%|
|Ct < 30 (all)||26||96.2%||81.1-99.3%|
|Ct < 28 (all)||22||100%||85.1-100.0%|
1. La Scola B., Le Bideau M., Andreani J., Hoang V.T., Grimaldier C., Colson P. Viral RNA load as determined by cell culture as a management tool for discharge of SARS-CoV-2 patients from infectious disease wards. Eur J Clin Microbiol Infect Dis. 2020:1–3.
Not all products are available in all countries and regions. Please check with your local LumiraDx sales representative or distributor for availability in specific markets. Not available in the USA.
Supporting healthier lives, for individuals, communities and wider society
Enabling responsive, personal relationships between patients and care teams.
Controlling and reducing costs to help ease pressure on healthcare budgets.