Controls for Direct SARS-COV-2 Assay. 1mL

• External Negative/Positive Control for Molecular Testing
• Compatible with the Lyra Direct SARS-CoV-2 Assay
• Supports Routine Laboratory Quality Control
• Refrigerated Storage at 2 - 8°C
• Usable up to 24 Months .

The Quidel Controls are external quality control material intended for use with the Lyra Direct SARS-CoV-2 Assay. These 1 ml control vials enable laboratories to perform routine quality control procedures and helps verify that the assay is operating as expected.

✦ ✦ ✦ FEATURES ✦ ✦ ✦

• External Quality Control: Intended for use as either a positive or a negative control during molecular testing with the Lyra Direct SARS-CoV-2 Assay.
• Storage Mandate: Formulated to maintain stable chemical properties when kept under strict cold-chain refrigeration at temperatures 2°C - 8°C, and can be used up to 24 months.
• Routine Performance Verification: Used as part of established laboratory quality control procedures to verify proper assay performance.
• Procedural Protocol: Must be treated like a patient specimen and consistently processed through all extraction and RT-PCR steps alongside patient samples to ensure run-by-run testing integrity.

The Quidel Controls provide laboratories with a manufacturer-designated external controls for routine quality assurance when performing molecular SARS-CoV-2 testing using the Lyra Direct SARS-CoV-2 Assay.

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.