Industry News: George Mason University employs rapid-result COVID-19 tests to control the spread of virus on campus

The testing capacity provided by the Fluidigm system aims to help the university limit the spread of the virus

11 Feb 2021

Fluidigm Corporation, an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, has announced that George Mason University in Fairfax, Va., is providing saliva-based COVID-19 testing using the Advanta™ Dx SARS-CoV-2 RT-PCR Assay on the Fluidigm® Biomark™ HD system.

As part of an expansion of testing capacity for GMU students and employees, the university purchased two Biomark HD systems and has equipped labs on the university’s Science and Technology Campus in Manassas, Va., to process the Advanta Dx Assay, with initial plans to run approximately 10,000 tests per week.

“Frequent and reliable testing is the core of our plan to keep students and staff safe at GMU,” said Ali Andalibi, PhD, Professor and Senior Associate Dean in the College of Science at GMU. “Adoption of the Advanta Dx SARS-CoV-2 RT-PCR Assay is one element of a plan to greatly expand our capacity. The noninvasive nature of the assay, accuracy and time to results are among key advantages of the Fluidigm system, which we have combined with an automation platform for testing at scale.

“The testing capacity provided by the Fluidigm system, along with systematic precautionary measures such as masks and social distancing, will help us limit the spread of the virus at Mason.”

Fluidigm has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus in individuals suspected of COVID-19 by their health care providers. The assay does not require collection via invasive nasopharyngeal swab, and the company’s submission to the FDA demonstrated 100 percent agreement between saliva results from the Advanta Dx Assay and results from paired nasopharyngeal samples tested with authorized assays.

A growing body of peer-reviewed research is confirming that the accuracy of saliva-based COVID-19 testing is comparable to that of nasopharyngeal-based testing. A systematic review and meta-analysis published in JAMA Internal Medicine in January 2021 stated that saliva-based tests have a similar sensitivity and specificity and present an attractive alternative to invasive nasopharyngeal testing.

“Fluidigm is grateful for the opportunity to enable simple, affordable and accessible testing to help keep colleges and universities open and their staffs and students healthy,” said Chris Linthwaite, Fluidigm President and CEO. “We are proud of our collaborations with a number of higher education institutions to provide a test with a sample type that is far easier to collect than invasive swabs, and that individuals often prefer from a comfort perspective.”

Fluidigm continually conducts in silico analyses to determine the effectiveness of the Advanta Dx Assay design to detect SARS-CoV-2. To date, none of the published viral mutations meaningfully impact the regions of the viral genome targeted by the assay’s primers and probes.

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 the 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.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in saliva specimens during the acute phase of infection. 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. 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 patient management decisions. Negative results must be combined with clinical observations, patient 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 and trained 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.

Other Fluidigm products are provided for Research Use Only. Not for use in diagnostic procedures.

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