Rally #188-1-2387
Quidel #20387
Respiratory Test Kit QuickVue® Professional Use SARS Antigen 25 Tests CLIA Waived
TEST KIT, SARS ANTIGEN QUICKVUE PROFESSIONAL USE (25/KT)
Features
- Dipstick test format
- Results in 10 minutes
- Two-color result
- All components included in kit
- Room temperature storage
- CLIA-waived for use at point-of-care
- Accurate detection with direct anterior nares swab samples: 96.6% PPA and 99.3% NPA
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. The QuickVue SARS Antigen test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings.
- Authorization -
For use under an Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.
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.
- Results -
The QuickVue SARS Antigen test does not differentiate between SARS-CoV and SARS-CoV-2.
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status; positive results do not rule out bacterial infection or co-infection with other viruses.
Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed; negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.
Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.
Product Specifications
| Manufacturer # | 20387 |
| Brand | QuickVue® Professional Use |
| Manufacturer | Quidel |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| CLIA Classified | CLIA Waived |
| Contents 1 | (25) Individually Packaged Test Strips, (25) Reagent Tubes, (25) Vials of Reagent Solution with 340 µL Salt Solution, (25) Sterile Nasal Swabs, SARS Positive Control Swab, Negative Control Swab, Package Insert, and Procedure Card |
| Number of Tests | 25 Tests |
| Reading Type | Visual Read |
| Sample Type | Nasal Swab Sample |
| Specialty | Immunoassay |
| Test Format | Test Strip Format |
| Test Kit Type | Rapid |
| Test Method | Lateral Flow Method |
| Test Name | SARS Antigen |
| Time to Results | 10 Minute Results |
| UNSPSC Code | 41116144 |
WARNING: This product can expose you to chemicals which are known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.p65Warnings.ca.gov.
More Information
- CLSI - QuickVue SARS Antigen Test
- FAQ - QuickVue SARS Antigen Test
- HCP Fact Sheet - QuickVue SARS Antigen Test
- Package Insert - QuickVue SARS Antigen Test (EUA)
- Patient Fact Sheet - QuickVue SARS Antigen Test
- Quick Reference Instructions - QuickVue SARS Antigen Test (EUA)
- Quiz - QuickVue SARS Antigen Test
- SDS - QuickVue SARS Antigen Test
- Sales Sheet - QuickVue SARS Antigen Test
- Technical Bulletin - Antigen vs. Antibody Testing
- Technical Bulletin - Detection of SARS-CoV-2 and SARS-CoV
- QuickVue SARS Antigen Test FDA EUA Letter
- Quidel 12.28.21 Omicron Variant Letter
- QuickVue SARS Antigen Test Extended Expiration Date Letter Aug 8.11.21
