SARS-CoV-2 Ag Ultra

an easy to use, fast microfluidic immunofluorescence assay designed to rapidly quantify nucleocapsid protein antigen in nasal and nasopharyngeal swab specimens. Used with the LumiraDx Platform, the LumiraDx SARS-CoV-2 Ag Ultra test provides actionable, lab-comparable results for patients suspected of COVID-19 in just 5 minutes.

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Qualitative SARS-CoV-2 Ag Ultra test

The LumiraDx SARS-CoV-2 Ag Ultra test is an automated rapid microfluidic immunofluorescence assay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 directly from anterior nasal swab samples collected from individuals suspected of COVID-19.

Near-patient testing

As an automated in vitro diagnostic test, it is made for near-patient testing with the LumiraDx Instrument.

Purpose

The test is a single use fluorescence immunoassay designed to detect the presence of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab samples, without transport media.

Benefits

Rapidly identify COVID-19 in just 5 minutes

Optimize your clinical workflow, verify potential infection quickly and help triage patients without delay:

Optimize clinical workflows - accurately and confidently test more patients
Sample type: nasal swab
High sensitivity to Ct <34 within 12 days of the onset of symptoms
Nasal swabs:
- 97.4%* PPA versus RT-PCR with symptoms
- 95.7% PPA versus RT-PCR without symptoms
- 100% NPA
Time to result: 5 minutes
Storage at room temperature (2°C to 30°C)

* Ct <34 Refer to SARS-CoV-2 Ag Ultra Product Insert for full clinical data

Workflow

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 5 minutes from sample application.

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.

HOW TO USE VIDEO

Test Performance

Symptomatic and asymptomatic data

In clinical studies, the LumiraDx SARS-CoV-2 Ag Ultra test demonstrated 97.4% positive agreement versus RT-PCR in samples to Ct <34 from individuals with symptoms up to and including 12 DSSO and 95.7% for asymptomatic individuals.

Analytical performance

The limit of detection was found to be 800 TCID₅₀/mL using a starting concentration of 1.26 x 10⁶ TCID₅₀/mL with 20/20 positive results.

Cross reactivity

SARS-CoV-2 Ag Ultra test was found not to cross-react with a panel of organisms and viruses including several human coronaviruses. See LumiraDx SARS-CoV-2 Ag Ultra Product Insert for full details.