QuickVue SARS Antigen Test (For Professional Use)

QuickVue SARS Antigen Test

The QuickVue SARS Antigen Test is a lateral flow immunoassay that allows for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. 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.

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Product Description

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.

REAGENTS AND MATERIALS SUPPLIED
25-Test Kit:
◼ Individually Packaged Test Strips (25): Monoclonal anti-SARS antibodies
◼ Reagent Tubes (25): Lyophilized buffer with detergents and reducing agents
◼ Reagent Solution (25): Vials with 340 μL salt solution
◼ Sterile Nasal Swabs (Kit #20387) (25)
◼ SARS Positive Control Swab (1): Swab is coated with non-infectious recombinant SARS antigens
◼ Negative Control Swab (1): Swab is coated with heat-inactivated, non-infectious Streptococcus C antigen
◼ Package Insert (1)
◼ Procedure Card (1)

Features and Benefits

• Dipstick test format-Simple workflow follows a similar format to CLIA-waived QuickVue assays. No instrument necessary.

• Rapid results in 10 minutes

• 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.

 

 

 

 

 

 

 

 

 

 

 

 

IMPORTANT: Please refer to package insert (instructions for use) for more comprehensive product information.

 

PRODUCT DETAILS

Catalog Number Description Units of Measurements
QV20387 QuickVue Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen  25 Tests/Kit

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Product Documentation

 

The QuickVue COVID-19 Antigen Rapid Test Kit product insert, authorized Fact Sheet for Healthcare Providers, authorized Fact Sheet for Recipients and quick reference instructions are provided below:

QuickVue Product Insert

QuickVue Healthcare Providers Fact Sheet

QuickVue Patient Fact Sheet

QuickVue Quick Reference Instructions