Lyra SARS-CoV-2 Assay w/ Swab Collection Set (96/bx)

• Complete 96-Test Real-Time RT-PCR Kit
• Includes 100 Swabs & 100 Transport Media
• Provides Qualitative Detection of SARS-CoV-2 RNA
• Features Ready-to-Use Microwell Format Reagents
• Compatible w/ Common Real-Time PCR Instrument Platforms
• Designed for Professional In Vitro Diagnostic Use .

The Quidel Lyra SARS-CoV-2 Assay w/ Swab Collection Set is a real-time RT-PCR in vitro diagnostic assay designed for the qualitative detection of SARS-CoV-2 RNA from swab specimens collected from individuals suspected of COVID-19. Supplied as a complete 96-test kit, it includes a complete test kit to support standardized specimen collection and molecular testing in professional laboratory settings.

✔ COMPLETE ASSAY KIT | ✔ MOLECULAR SARS-CoV-2 DETECTION | ✔ LABORATORY READY

COMPLETE TESTING SOLUTION

• COMPLETE KIT CONTENTS: Each kit provides reagents for 96 molecular tests and includes one 96-well deep-well plate, 100 sterile nasal or oropharyngeal swabs, and 100 transport media to support specimen collection and processing.
• QUALITATIVE SARS-CoV-2 DETECTION: Utilizes real-time reverse transcription polymerase chain reaction (RT-PCR) technology for the qualitative detection of SARS-CoV-2 RNA in respiratory specimens.
• STANDARDIZED SPECIMEN COLLECTION: Includes manufacturer-specified swabs and transport media to help ensure proper specimen collection and transport for the Lyra SARS-CoV-2 testing workflow.

EFFICIENT MOLECULAR WORKFLOW

• MICROWELL FORMAT: Ready-to-use microwell assay format supports efficient batch testing and streamlined laboratory workflow.
• IN VITRO DIAGNOSTIC USE: Intended for professional use by qualified laboratory personnel in accordance with the Lyra SARS-CoV-2 Assay Instructions for Use.
• COMPLETE TESTING PACKAGE: Combines specimen collection components and molecular assay reagents into a single kit, minimizing the need to source compatible collection materials separately.

The Quidel Lyra SARS-CoV-2 Assay w/ Swab Collection Set provides clinical laboratories with a comprehensive molecular testing solution that combines standardized specimen collection materials and RT-PCR assay reagents 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.