Complete 96-Test Real-Time RT-PCR SARS-CoV-2 Kit. Includes 100 Swabs & 100 Transport Tubes. Features Microfuge Tube Format for Flexible Testing. Delivers Results in Less Than 75 Minutes After Extraction. Utilizes One-Step Reagent Setup w/ Lyophilized Master Mix. Designed for Professional In Vitro Diagnostic Use. The Quidel Lyra Direct SARS-CoV-2 Assay w/ Swab & Microfuge Tube is a real-time RT-PCR in vitro diagnostic assay intended for the qualitative detection of SARS-CoV-2 RNA extracted from respiratory swab specimens. Supplied as a 96-test kit, it includes a complete set of materials, providing laboratories with a streamlined molecular testing solution for professional SARS-CoV-2 detection. ✔ RAPID MOLECULAR DETECTION | ✔ FLEXIBLE MICROFUGE FORMAT | ✔ COMPLETE TESTING KIT. ACCURATE MOLECULAR DETECTION. REAL-TIME RT-PCR TECHNOLOGY: Utilizes real-time reverse transcription polymerase chain reaction (RT-PCR) technology for the qualitative detection of SARS-CoV-2 RNA by targeting the non-structural polyprotein (pp1ab) region of the viral genome. COMPLETE TEST KIT: Includes reagents for 96 tests, 100 nasopharyngeal/oropharyngeal swabs, and 100 transport tubes, providing the essential components required for specimen collection and molecular testing. BROAD SPECIMEN COMPATIBILITY: Intended for testing viral RNA extracted from nasopharyngeal (NP) or oropharyngeal (OP) nasal swab specimens collected from individuals suspected of COVID-19. FAST TURNAROUND: Delivers results in less than 75 minutes after extraction to support timely molecular diagnostic testing. STREAMLINED LABORATORY WORKFLOW. MICROFUGE TUBE FORMAT: Uses an individual microfuge tube workflow, offering flexibility for laboratories processing smaller batches of specimens. ONE-STEP REAGENT SETUP: Lyophilized Master Mix is reconstituted by adding the supplied rehydration solution, minimizing reagent preparation steps. SIMPLIFIED SAMPLE PREPARATION: Incorporates a streamlined three-step sample preparation process with standardized pipetting volumes to support efficient laboratory workflows. PROFESSIONAL PERFORMANCE: Intended for professional in vitro diagnostic use by qualified laboratory personnel and validated for use on supported real-time PCR instrument platforms specified in the manufacturer's Instructions for Use. The Quidel Lyra Direct SARS-CoV-2 Assay w/ Swab & Microfuge Tube provides clinical laboratories with a complete RT-PCR testing solution that combines standardized specimen collection materials, a flexible microfuge tube workflow, and reliable qualitative detection of SARS-CoV-2 RNA. **FDA Disclaimer: This test is not FDA cleared or approved, but only authorized under an Emergency Use Authorization for use by authorized laboratories. It is authorized for the rapid detection of proteins from SARS-CoV-2 and 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 the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. WARNING: This product can expose you to chemicals known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.
