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

• Complete 96-Test Real-Time RT-PCR SARS-CoV-2 Assay Kit
• Includes 100 Nasopharyngeal Swabs & 100 Transport Tubes
• Features One-Step Reagent Setup w/ Lyophilized Master Mix
• Delivers Results in Less Than 75 Minutes After Extraction
• Provides Microwell Format w/ 96-Well Deep-Well Plate
• Designed for Professional In Vitro Diagnostic Use .

The Quidel Lyra Direct SARS-CoV-2 Assay w/ Swab & Microwell Plate is a real-time RT-PCR in vitro diagnostic assay intended for the qualitative detection of SARS-CoV-2 RNA extracted from swab specimens collected from patients with signs and symptoms of COVID-19. Supplied as a 96-test kit, it includes complete materials to support efficient specimen collection and molecular testing in professional laboratory environments. 

✔ FAST MOLECULAR DETECTION | ✔ STREAMLINED 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 tests, one 96-well deep-well plate, 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), nasal, and oropharyngeal (OP) swab specimens collected from individuals suspected of COVID-19.

RAPID RESULTS: Delivers results in less than 75 minutes after extraction, helping laboratories provide timely molecular diagnostic results.

STREAMLINED LABORATORY WORKFLOW

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 consistent laboratory workflows.

BROAD INSTRUMENT COMPATIBILITY: Validated for use on supported real-time PCR platforms, including Applied Biosystems™, Roche, Qiagen, Bio-Rad, and Thermo Fisher Scientific systems specified in the manufacturer's Instructions for Use.

PROFESSIONAL PERFORMANCE: Designed for professional in vitro diagnostic use by qualified laboratory personnel and stored refrigerated at 2°C to 8°C as recommended by the manufacturer.

The Quidel Lyra Direct SARS-CoV-2 Assay w/ Swab & Microwell Plate provides clinical laboratories with a complete RT-PCR testing solution that combines standardized specimen collection components, streamlined workflow, and reliable molecular 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.