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 testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.
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)
Information for Healthcare Professionals
Information for Laboratories
Laboratory Biosafety
Isolation Precautions in Healthcare Settings
Specimen Collection
Infection Control
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)
Features & Benefits
| Feature | Benefit |
|---|---|
Dipstick test format | Simple workflow follows a similar format to CLIA-waived QuickVue assays. No instrument necessary. |
Results in 10 minutes | Test and treat in the same office visit. |
Two-color result | Easy to read and interpret. Blue control line and red test line. |
All components included in kit | Ready to use, no need for additional equipment. |
Room temperature storage | No refrigerator space needed. No need to wait for reagents to warm up. Rapid SARS-CoV-2 tests can be run immediately as needed. |
Product Specifications
| Product Spec Name | Product Spec Data |
|---|---|
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% |
Shelf life | 12 months from date of manufacture |
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.
Ordering Information
| Catalog Number | Description | Kit Size / Case Size |
|---|---|---|
20387 | Test Kit | 25/10 |
20389 | Control Swab Set for additional QC | |
20385 | Transport Tubes (25 swabs) |
Product Documentation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
