Fluidigm Has Obtained CE-IVD Marking for the Advanta Dx SARS-CoV-2 RT-PCR Assay
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.
- Instructions for Use
- Advanta Dx SARS-CoV-2 Interpretive Software Quick Reference Guide
- Download Advanta Dx SARS-CoV-2 interpretive software
- Download Biomark software
- Download IFC Controller software
- Read letter regarding new SARS-CoV-2 strain
Advanta Dx SARS-CoV-2 RT-PCR Assay Reagent and IFC BundleOrdering information
The Advanta Dx SARS-CoV-2 RT-PCR Assay is a reverse transcription (RT) and real-time polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in saliva from patients who are suspected of COVID-19.
Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient 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.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Advanta Dx SARS-CoV-2 RT-PCR Assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.
Fluidigm collaborated with the Washington University School of Medicine in St. Louis to develop the SARS-CoV-2 saliva test.
“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, MD, PhD
Executive Director of the McDonnell Genome Institute and Head of the Department of Genetics at Washington University School of Medicine
“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