Lyra Direct SARS-CoV-2 Assay w/ VTM & Microwell Plate (96/bx)

• Complete 96-Test Real-Time RT-PCR SARS-CoV-2 Assay Kit
• Includes Viral Transport Media (VTM) Tubes & Deep-Well Plate
• Features One-Step Reagent Setup w/ Lyophilized Master Mix
• Delivers Results in Less Than 75 Minutes After Extraction
• Provides High-Throughput Microwell Testing Format
• Designed for Professional In Vitro Diagnostic Use .

The Quidel Lyra Direct SARS-CoV-2 Assay w/ VTM & Microwell Plate 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 collected from individuals suspected of COVID-19. Supplied as a complete 96-test kit, it includes all components to support efficient specimen processing and high-throughput molecular testing in professional laboratory environments.

✔ FAST MOLECULAR DETECTION | ✔ HIGH-THROUGHPUT WORKFLOW | ✔ 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 molecular tests, one 96-well deep-well plate, and 100 Viral Transport Media (VTM) tubes to support standardized specimen collection and laboratory workflow.
• BROAD SPECIMEN COMPATIBILITY: Intended for 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, supporting timely molecular diagnostic testing.

STREAMLINED LABORATORY WORKFLOW

• MICROWELL FORMAT: Utilizes a 96-well deep-well plate format designed to support efficient batch processing and high-throughput molecular testing.
• ONE-STEP REAGENT SETUP: Lyophilized Master Mix is reconstituted using the supplied rehydration solution, reducing reagent preparation steps and simplifying laboratory workflow.
• VTM COLLECTION SYSTEM: Includes 100 Viral Transport Media (VTM) tubes to facilitate specimen transport and preparation prior to molecular testing.
• PROFESSIONAL PERFORMANCE: Intended for professional in vitro diagnostic use by qualified laboratory personnel and validated for use on supported real-time PCR instrument platforms in accordance with the manufacturer's Instructions for Use.

The Quidel Lyra Direct SARS-CoV-2 Assay w/ VTM & Microwell Plate provides clinical laboratories with a complete RT-PCR testing solution that combines streamlined reagent preparation, high-throughput microwell processing, and standardized specimen collection components for 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.