The Advanta™ Dx SARS-CoV-2 RT-PCR Assay is a qPCR-based test that, by taking advantage of Fluidigm proprietary microfluidics technology and the Juno™ and Biomark™ HD systems, enables reliable, high-capacity testing of saliva samples from patients suspected by their health care providers of COVID-19 (coronavirus) infection to support diagnostic decision making.

The assay has been authorized for use under FDA Emergency Use Authorization (EUA) and is CE-IVD marked under the In Vitro Diagnostics Directive (IVDD 98/79/EC).

Test Platform Highlights

• Saliva-based test: The test performs equivalently to comparator nasal tests but utilizes convenient and noninvasive sample collection.
• Easy supply chain burden: Saliva can be collected using any sterile, preservative-free sample container, and the extraction-free workflow eliminates the need for viral RNA extraction kits.
• Lower sample volume requirements: Our microfluidic workflow uses an industry-leading 15 µL of sample input, 10x less than traditional microwell RT-PCR methods, improving sample acceptance rates and preserving precious samples for use in other applications.
• High test capacity: Modular platform supports concurrent parallel runs to test up to 6,000* samples and controls per day per instrument.

*Actual results may vary based upon the following factors, including but not limited to, laboratory processes, workflows, equipment and the number of operators.