Quidel QuickVue SARS Antigen Dipstick, CLIAwaived (QUI 20387)

QuickVue SARS Antigen Dipstick, 25 tests/kit (450 kt/plt) (Non-cancellable; Non-returnable; Non-refundable) (Continental US Only - including Alaska & Hawaii)
CPT Code: 87811-QW* | (Short-Dated, Minimum Expiry Lead is 4 months) | FDA Emergency Use Authorization | CLIAwaived

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.

Features/Benefits

• Identifies SARS-CoV-2 antigens in 10 minutes for better patient management decisions
• Accurate detection with direct anterior nares swab samples: 96.6% PPA and 99.3% NPA
• Simple workflow follows a similar format to CLIA-waved QuickVue assays, just sample, dip, and read
• Each kit contains everything needed to perform the test, including nasal swabs and Positive and Negative controls
• Room temperature storage with 12-month shelf life from date of manufacture Feature
• Dipstick test format
• Results in 10 minutes
• Two-color result
• All components included in kit
• Room temperature storage
• EUA: Benefit - Simple workflow follows a similar format to CLIA-waived QuickVue assays. No instrument necessary.
• Test and treat in the same office visit.
• Easy to read and interpret. Blue control line and red test line.
• Ready to use, no need for additional equipment.
• No refrigerator space needed. No need to wait for reagents to warm up. Rapid SARS-CoV-2 tests can be run immediately as needed.
  

Specifications

• Sample type: Anterior nares swab
• Time to results: 10 minutes
• Kit storage conditions: Room temperature (15degC to 30degC/59degF to 86degF)
• 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 The QuickVue SARS Antigen Test has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1), unless authorization is terminated or revoked sooner.