COVID-19 Diagnostics

A High-Throughput Extraction-Free Diagnostic
SARS-CoV-2 Detection Test

For Use Under Emergency Use Authorization Only


Fluidigm Has Developed a High-Throughput Extraction-Free Diagnostic Test for the Detection of SARS-CoV-2 in Saliva for Use Under FDA EUA


Non-US customers, please visit our CE-IVD version.

Advanta Dx SARS-CoV-2 RT-PCR Assay

Fluidigm has developed a diagnostic molecular test for the qualitative detection of SARS-CoV-2 in saliva specimens for use under FDA Emergency Use Authorization (EUA).

The Advanta™ Dx SARS-CoV-2 RT-PCR Assay is a qPCR-based test that, by taking advantage of Fluidigm proprietary microfluidics technology and Juno™ and Biomark™ HD systems, enables high-throughput and scalable testing of saliva samples from patients suspected of COVID-19 (coronavirus) infection. Featuring extraction-free sample processing, a modular workflow and large batch-sample size, the Advanta Dx SARS-CoV-2 RT-PCR Assay could enhance laboratory testing capacity while providing reliable results to support clinical decision making.

Detecting the New Strain of Coronavirus

The Advanta Dx SARS-CoV-2 RT-PCR Assay design supports, based on an in silico analysis, detection of currently known new strains of coronavirus, including SARS-CoV-2 VUI-202012/01 (or B.1.1.7) and 20C/501Y.V2 (or B.1.351). None of the genetic variants in these strains are in regions of the viral genome targeted by the assay’s primers and probes.

Test Platform Highlights

  • Saliva-based test: Performs equivalently to comparator nasal tests but utilizes convenient and noninvasive sample collection.
  • Simpler supply chain: 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 achieve 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.

Advanta Dx SARS-CoV-2 RT-PCR Assay Reagent and IFC Bundle

Ordering information

Intended Use

The Advanta Dx SARS-CoV-2 RT-PCR Assay is a real-time Reverse Transcription (RT) PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider.

Testing is limited to laboratories which are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high complexity tests.

This test is also for use with saliva specimens that are self-collected at home with or without the supervision of a healthcare provider (HCP) with the AZOVA COVID-19 Test Collection Kit from individuals suspected of COVID-19 by their HCP.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in saliva during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with individual history and other diagnostic information is necessary to determine individual infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for individual management decisions. Negative results must be combined with clinical observations, individual history, and epidemiological information. Negative results for SARS CoV 2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated.

The Advanta Dx SARS-CoV-2 RT-PCR Assay is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Advanta Dx SARS-CoV-2 RT-PCR Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.


Collaboration



Fluidigm collaborated with the Washington University School of Medicine in St. Louis to develop the SARS-CoV-2 saliva test and file for EUA.
“The close collaboration between teams at Washington University and Fluidigm aided our efforts to quickly develop this high-throughput assay for SARS-CoV-2 that relies on a saliva sample. Such a test could help overcome supply chain bottlenecks that have limited testing for COVID-19 and help identify infections.”

Jeffrey Milbrandt
—Jeffrey Milbrandt, MD, PhD
Executive Director of the McDonnell Genome Institute and Head of the Department of Genetics at Washington University School of Medicine



Simple Low-Labor Workflow

“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.”

Richard
—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.

Intended Use

The Advanta Dx SARS-CoV-2 RT-PCR Assay is a real-time Reverse Transcription (RT) PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider.

Testing is limited to laboratories which are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high complexity tests.

This test is also for use with saliva specimens that are self-collected at home with or without the supervision of a healthcare provider (HCP) with the AZOVA COVID-19 Test Collection Kit from individuals suspected of COVID-19 by their HCP.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in saliva during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with individual history and other diagnostic information is necessary to determine individual infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for individual management decisions. Negative results must be combined with clinical observations, individual history, and epidemiological information. Negative results for SARS CoV 2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated.

The Advanta Dx SARS-CoV-2 RT-PCR Assay is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Advanta Dx SARS-CoV-2 RT-PCR Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

  • 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.

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. ©2021 Fluidigm Corporation. All rights reserved. 01/2021