FDA Emergency Use Authorization
The QuickVue SARS Antigen Test detects SARS-CoV-2 antigens directly from anterior nares swab specimens. The QuickVue SARS antigen test provides accurate and reliable results in 10 minutes, allowing for COVID-19 testing of symptomatic patients within the first five days of symptoms and asymptomatic patients when tested serially.
Healthcare professionals can purchase the QuickVue SARS antigen test through select authorized distributors.
Where can I go for updates and more information?
CDC:
General Information - Coronavirus (COVID-19)
Laboratory Biosafety
FDA:
General Information - Coronavirus (COVID-19)
Emergency Use Authorizations
Additional Information - Quidel's EUA COVID-19 Products (Scroll down to the list of EUA products and enter “Quidel” in the search box)
Catalog number: 20387
Description: Test kit
Kit size/Case size: 25/10
Catalog number: 20385
Description: Test kit (Nasal swabs) XUS
Kit size/Case size: 25/10
Catalog number: 20385
Description: Transport tubes (25)
FDA Emergency Use Authorization
The QuickVue SARS Antigen Test detects SARS-CoV-2 antigens directly from anterior nares swab specimens. The QuickVue SARS antigen test provides accurate and reliable results in 10 minutes, allowing for COVID-19 testing of symptomatic patients within the first five days of symptoms and asymptomatic patients when tested serially.
Healthcare professionals can purchase the QuickVue SARS antigen test through select authorized distributors.
Where can I go for updates and more information?
CDC:
General Information - Coronavirus (COVID-19)
Laboratory Biosafety
FDA:
General Information - Coronavirus (COVID-19)
Emergency Use Authorizations
Additional Information - Quidel's EUA COVID-19 Products (Scroll down to the list of EUA products and enter “Quidel” in the search box)
Catalog number: 20387
Description: Test kit
Kit size/Case size: 25/10
Catalog number: 20385
Description: Test kit (Nasal swabs) XUS
Kit size/Case size: 25/10
Catalog number: 20385
Description: Transport tubes (25)
Features & benefits
Dipstick test format means no instrument necessary.
Results in 10 minutes – test and treat in the same office visit.
Two-color easy to read and interpret results.
To access safety data sheets, package inserts, quick reference guides and all other technical and promotional materials, visit our technical documents library.
- Specifications
| Product specifications | |
|---|---|
| Sample type | Anterior nares swab |
| Time to results | 10 minutes |
| Kit storage conditions | Room temperature (15°C to 30°C/59°F to 86°F) |
| Internal controls | Included |
| External controls | Positive and negative included |
| PPA (Reference Extracted SARS-CoV-2 RT-PCR Assay) | 96.6% |
| NPA (Reference Extracted SARS-CoV-2 RT-PCR Assay) | 99.3% |
| CLIA complexity | Waived* |
*Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
