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 under 5 minutes from sample application.
In clinical studies, the LumiraDx SARS-CoV-2 Ag Ultra test demonstrated 97.4%* positive agreement versus RT-PCR from individuals with symptoms.
See LumiraDx SARS-CoV-2 Ag Ultra Pool Product Insert for more details
The following table shows the performance grouped by Ct value, illustrating that the LumiraDx SARS-CoV-2 Ag Ultra 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 test can rapidly identify potentially contagious spreaders.
|Ct < 34 (all)||39||97.4%|
|Ct < 33 (all)||38||97.4%|
|Ct < 30 (all)||35||97.1%|
|Ct < 25 (all)||25||100.0%|
In clinical studies, the LumiraDx SARS-CoV-2 Ag Ultra test demonstrated 95.7% positive agreement versus RT-PCR in samples collected from individuals without symptoms or other epidemiological reasons to suspect COVID-19.
With the Omicron variant showing a much higher rate of asymptomatic carriage compared to other variants2, the high sensitivity of the LumiraDx SARS-CoV-2 Ag Ultra Test can be an important tool in breaking the chain of transmission.
Refer to SARS-CoV-2 Ag Ultra Product Insert for full clinical data
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.
2. Garrett N, Tapley A, Andriesen J, et al. High Rate of Asymptomatic Carriage Associated with Variant Strain Omicron. Preprint. medRxiv. 2022;2021.12.20.21268130. Published 2022 Jan 14. doi:10.1101/2021.12.20.21268130
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.
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