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Quidel Corporation

Quidel QuickVue® SARS-CoV-2 Antigen Test

$400.00 per package (25 tests per package)

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.

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Description

The QuickVue SARS Antigen Test detects SARS-CoV-2 antigens directly from anterior nares swab specimens. Approved for point-of-care settings, 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. You can read the instructions for use here.

Features

  • 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 Details

Does this test have an Emergency Use Authorization (EUA)?

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.

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%
  • 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.

Where can I go for updates and more information?

Product Training: https://quickvuetraining.com/quickvue

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)

Sample Details

Nasal swab

Payment Methods
  • Credit Card
  • HSA Card
  • ACH
  • PayPal
  • PO Number

Note: These products and services are not returnable.

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Questions?

Call (888) 204-5303 or email support@meenta.io

More information about COVID-19 can be found on the CDC website and the Meenta blog.