Description
The 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 or, from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests.. 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.
Specimen type: Nasal (NS) swab specimen
Turnaround time: 10-15 minutes
FDA status: Emergency Use Authorization (EUA) Granted
CLIA complexity: Waived, Moderate, or High
- *This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by authorized laboratories;
- This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and,
- The emergency use of this product 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 the declaration is terminated or authorization is revoked sooner.
Features :
- Hygienic Product : Not Specified
- Allergy : Not Specified
Specifications
- UPC:Not Specified
- GTIN/ITF Barcode : Not Specified
- Units of Measure : Not Specified
- Overall Product Length : Not Specified in
- Overall Product Width : Not Specified in
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- Weight Capacity : Not Specified lbs
- Actual Product Weight : 0.80
- Product Assembly : Not Specified
- Product Installation : Not Specified
- Country of Origin : Not Specified
- Case QTY : Not Specified/case
- Case Weight : Not Specified
- Ships Via Freight : No
- Proposition 65 Warning : Not Specified