(Short-Dated, Minimum Expiry Lead is 4 months)
(Orders are Non-Cancellable; Item is Non-Returnable)
**Item on Manufacturer Backorder - Inventory Limited when Available - Rolling Backorder - Will ship immediately upon restock**
FDA Emergency Use Authorization, CLIAwaived
CPT is 87811-QW*
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.
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.
Covid Attributes: Type: Antigen / Rapid
Use: Lab / Clinical
Certification: CLIA Certificate Required for purchase
Sample SpecimenType: Nasal Swab
Availability: Ready to ship (typically ships within 7 days)
This product has the following special restrictions:
- Requires CLIA Certification
- Product is not returnable
- Product is not cancellable
No Cancellations; No Returns; All Sales Final. Exclusions may apply.
All returns must be approved by our Returns Department. An e-mail notification will be issued regarding your return status and return instructions, should this apply. Any product returned for credit without an authorized RMA number clearly printed on the outside package or shipping label will be refused. Unauthorized returns will not be honored or accepted for credit.
MedPlus:
MedPlus Services USA, exclusively for medical and dental distributors, is your one-stop, single source for purchasing medical and dental products and supplies at competitive prices. With over 300 healthcare and dental manufacturers' products in stock and available from our warehouses, you are well positioned to meet the needs of your customer. More importantly, you will be competitive in today's challenging marketplace. MedPlus Services allows you to bundle your product purchases from manufacturers like: 3M, BD, Covidien/Kendall, Alere, Smith & Nephew and over 300 more onto one single purchase order.
- All items are not authorized for resale.
