COVID-19 Diagnostics
A High-Throughput Extraction-Free Diagnostic
SARS-CoV-2 Detection Test
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.
The assay has been authorized for use under FDA Emergency Use Authorization (EUA).
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.
Learn more about advantages of saliva-based testing.
Learn moreLearn how Fluidigm is helping schools and businesses with critical testing needs.
Community Connect“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.”
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—Richard Head
Director of the Genome Technology Access Center at the McDonnell Genome Institute
Get more information about the Advanta Dx SARS-CoV-2 RT-PCR Assay.
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