SARS-CoV-2 Ag Ultra Pool Test
a rapid microfluidic immunofluorescence assay designed to test 5 samples in 5 minutes. Used with the LumiraDx Platform, the LumiraDx SARS-CoV-2 Ag Ultra Pool test provides actionable, lab-comparable and cost-efficient results for pooled patient samples in just 5 minutes.
Qualitative SARS-CoV-2 Ag Ultra Pool test
The LumiraDx SARS-CoV-2 Ag Ultra Pool 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 1 to 5 anterior nasal swab samples.
Benefits
Rapidly identify COVID-19 in just 5 minutes
Verify potential infection and help guide infection control measures quickly:
- Save time: pooled testing can result in a 40 - 60% reduction in testing time and resources
- Sample type: nasal swab
- 93.1%* PPA versus RT-PCR
- Time to result: 5 minutes for up to 5 pooled samples
- Storage at room temperature (2°C to 30°C)
* Ct <34 Refer to SARS-CoV-2 Ag Ultra Pool 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 VIDEOTest Performance
Clinical performance
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.
In clinical studies, the LumiraDx SARS-CoV-2 Ag Ultra Pool test demonstrated 93.1% positive agreement versus RT-PCR in pooled samples to Ct <34.
Analytical performance
The limit of detection was found to be 400 TCID50/mL using a starting concentration of 1.26 x 106 TCID50/mL with 19/20 positive results.
Cross reactivity
SARS-CoV-2 Ag Ultra Pool 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 Pool Product Insert for full details.
Product Documentation
SARS-CoV-2 Ag Ultra Pool Test:
SARS-CoV-2 Ag Ultra Pool Test