{"product_id":"quidel-quickvue-sars-antigen-dipstick-cliawaived-qui-20387","title":"Quidel QuickVue SARS Antigen Dipstick, CLIAwaived (QUI 20387)","description":"\u003cp\u003eQuickVue SARS Antigen Dipstick, 25 tests\/kit (450 kt\/plt) (\u003cspan style=\"color: rgb(244, 8, 8);\"\u003eNon-cancellable; Non-returnable; Non-refundable\u003c\/span\u003e) (Continental US Only - including Alaska \u0026amp; Hawaii)\u003cbr\u003eCPT Code: 87811-QW* | (Short-Dated, Minimum Expiry Lead is 4 months) | FDA Emergency Use Authorization | CLIAwaived\u003c\/p\u003e\n\u003cp\u003e\u003cbr\u003eThe 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 COVID-19 testing of symptomatic patients within the first five days of symptoms and asymptomatic patients when tested serially.\u003c\/p\u003e\n\u003cp\u003eHealthcare professionals can purchase the QuickVue SARS antigen test through select authorized distributors.\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"text-decoration: underline;\"\u003e\u003cstrong\u003eFeatures\/Benefits\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eIdentifies SARS-CoV-2 antigens in 10 minutes for better patient management decisions\u003c\/li\u003e\n\u003cli\u003eAccurate detection with direct anterior nares swab samples: 96.6% PPA and 99.3% NPA\u003c\/li\u003e\n\u003cli\u003eSimple workflow follows a similar format to CLIA-waved QuickVue assays, just sample, dip, and read\u003c\/li\u003e\n\u003cli\u003eEach kit contains everything needed to perform the test, including nasal swabs and Positive and Negative controls\u003c\/li\u003e\n\u003cli\u003eRoom temperature storage with 12-month shelf life from date of manufacture Feature\u003c\/li\u003e\n\u003cli\u003eDipstick test format\u003c\/li\u003e\n\u003cli\u003eResults in 10 minutes\u003c\/li\u003e\n\u003cli\u003eTwo-color result\u003c\/li\u003e\n\u003cli\u003eAll components included in kit\u003c\/li\u003e\n\u003cli\u003eRoom temperature storage\u003c\/li\u003e\n\u003cli\u003eEUA: Benefit - Simple workflow follows a similar format to CLIA-waived QuickVue assays. No instrument necessary.\u003c\/li\u003e\n\u003cli\u003eTest and treat in the same office visit.\u003c\/li\u003e\n\u003cli\u003eEasy to read and interpret. Blue control line and red test line.\u003c\/li\u003e\n\u003cli\u003eReady to use, no need for additional equipment.\u003c\/li\u003e\n\u003cli\u003eNo refrigerator space needed. No need to wait for reagents to warm up. Rapid SARS-CoV-2 tests can be run immediately as needed.\u003cbr\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cspan style=\"text-decoration: underline;\"\u003e\u003cstrong\u003eSpecifications\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eSample type: Anterior nares swab\u003c\/li\u003e\n\u003cli\u003eTime to results: 10 minutes\u003c\/li\u003e\n\u003cli\u003eKit storage conditions: Room temperature (15degC to 30degC\/59degF to 86degF)\u003c\/li\u003e\n\u003cli\u003eInternal controls: Included\u003c\/li\u003e\n\u003cli\u003eExternal controls: Positive and negative included\u003c\/li\u003e\n\u003cli\u003ePPA (Reference Extracted SARS-CoV-2 RT-PCR Assay): 96.6%\u003c\/li\u003e\n\u003cli\u003eNPA (Reference Extracted SARS-CoV-2 RT-PCR Assay): 99.3%\u003c\/li\u003e\n\u003cli\u003eShelf life: 24 months from date of manufacture\u003c\/li\u003e\n\u003cli\u003eCLIA complexity: Waived*\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e*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.\u003c\/p\u003e\n\u003cp\u003eThis 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.\u003c\/p\u003e\n\u003cp\u003eThis 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.\u003c\/p\u003e","brand":"MedPlus","offers":[{"title":"Default Title","offer_id":48984245207256,"sku":"QUI 20387","price":188.72,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0711\/6737\/7624\/files\/20387.jpg?v=1726416733","url":"https:\/\/checkout.mdsupplies.com\/products\/quidel-quickvue-sars-antigen-dipstick-cliawaived-qui-20387","provider":"MDSupplies","version":"1.0","type":"link"}