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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. 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. Important Links 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.
CollaborationFluidigm 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.”
“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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