1.800.874.1517
English | Chinese

Search form


ONLY AVAILABLE FOR SALES IN THE U.S.
De Novo FDA clearance

For use with Sofia 2

The next generation of COVID-19 rapid testing, Sofia 2 SARS Antigen+ Fluorescent Immunoassay (FIA), uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2. The Sofia 2 SARS Antigen+ FIA, with the Sofia 2 analyzer, provides automated and objective results in 10 minutes, allowing for COVID-19 testing of symptomatic patients when serial testing is started within 6 days of symptom onset. Sofia 2 SARS Antigen+ FIA is the first FDA-cleared, 10-minute rapid antigen test for COVID-19.*

Sofia 2 SARS Antigen+ FIA will be available for healthcare professionals to purchase through authorized distributors soon. Contact your QuidelOrtho Account manager for more details.

Where can I go for updates and more information?

CDC:
General Information - Coronavirus (COVID-19)
Laboratory Biosafety

FDA:
General Information - Coronavirus (COVID-19)


Features & Benefits

FeatureBenefit

Results in 10 minutes

Rapid results to support efficient dispositioning of patients.

Objective, accurate results

Reliable results without cross-reactivity to seasonal coronaviruses.

Dual work modes

Adjusts to your volume fluctuations. Allows for significant throughput and batching of samples in READ NOW Mode.

Virena connection

Provides automated tracking, data capture, government reporting, and exclusive disease mapping.

Fluorescent technology with automated read

Objective result that eliminates the subjectivity of a visual read.

All necessary components included in kit

Ready for use with Sofia 2 for nasal swab procedure.

Self-contained Test Cassette

Clean, easy to use and dispose of.

Product Specifications

Product Spec NameProduct Spec Data
Time to results

10 minutes

Sample type

Direct nasal swabs

Kit storage conditions

Room temperature (15°C to 35°C / 59°F to 86°F)

Controls

Positive and negative, included in kit

PPA

89.0%

NPA

99.6%

CLIA complexity

Waived

Ordering Information

Catalog NumberDescriptionKit Size / Case Size
20405

Test Kit (US, Nasal Swabs)

25/12

Product Documentation

Product documentation is best viewed in Internet Explorer