Fluidigm Has Developed a High-Throughput Extraction-Free Diagnostic Test for the Detection of SARS-CoV-2 in Saliva.
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.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.
“There’s an urgent need to simplify testing for COVID-19 so that people who are infected can be easily and quickly identified. The test we developed in collaboration with Fluidigm doesn’t require RNA extraction, a time-consuming and expensive step necessary to other tests for SARS-CoV-2. Our test could be easily scaled up and made widely available.”
Director of the Genome Technology Access Center at the McDonnell Genome Institute
For In Vitro Diagnostic Use. For Use Under Emergency Use Authorization Only. Rx Only.
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
- 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 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.
Trademarks: Fluidigm, the Fluidigm logo, Advanta, Biomark and Juno are trademarks and/or registered trademarks of Fluidigm Corporation in the United States and/or other countries. All other trademarks are the sole property of their respective owners. ©2020 Fluidigm Corporation. All rights reserved. 11/2020