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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)
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

FeatureBenefit

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 NameProduct 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

24 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 NumberDescriptionKit Size / Case Size
20387

Test Kit

25/10
20389

Control Swab Set for additional QC

20385

Transport Tubes (25 swabs)

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