Visby Medical has announced that its instrument-free Reverse Transcription (RT)-Polymerase Chain Reaction (PCR) COVID-19 test was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for testing pooled patient samples in high-complexity Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories. This authorization for the pooled COVID-19 RT-PCR test extends the previous EUA for single patient sample testing at the point of care. Furthermore, this validates the flexibility and adaptability of the Visby Medical innovative, palm-sized PCR technology by expanding its proven capabilities from individual, single-use testing to pooled testing of up to five patient samples at once.
According to the U.S. Centers for Disease Control and Prevention (CDC), more than 32 million COVID-19 tests have been performed in the U.S. alone over the past month.1 Pooling patient samples with the Visby test can help increase overall lab testing capacity without additional tools or resources, while maintaining both accuracy and speed by returning results in less than 30 minutes.
“With the SARS-CoV-2 virus ravaging the country, Visby remains steadfast in meeting the urgent needs of the community, its partners, and the changing market dynamics with our instrument-free PCR COVID-19 test,” says Teresa Abraham, PhD, director of Medical Affairs at Visby Medical. “Thanks to this EUA, laboratories can meet increasing testing demand by analyzing up to five patient samples at once, allowing for significantly increased efficiency and significantly decreased testing costs, particularly in low prevalence settings.”
Pooling the Samples
The Company’s pooled COVID-19 RT-PCR test protocol enables high-complexity clinical laboratories to combine up to five patient samples into a single device for processing. A negative result means that all five individuals have tested negative for SARS-CoV-2. A positive result triggers all five samples to be re-tested individually to determine which patient or patients are infected.2
By shrinking PCR technology to palm-sized dimensions, the Visby Medical platform provides fast, accurate results. This single-use, instrument-free device quickly identifies COVID-19 infections, which is especially useful in communities with limited access to testing.
To learn more, visit Visby Medical.
Featured Image: An overview of how Visby Medical’s COVID sample pooling methodology works. Illustration: Visby Medical
- Centers for Disease Control and Prevention. COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#cases_tests30day. Access August 5, 2021.
- Centers for Disease Control and Prevention. Interim Guidance for Use of Pooling Procedures in SARS-CoV-2 Diagnostic and Screening Testing. https://www.cdc.gov/coronavirus/2019-ncov/lab/pooling-procedures.html. Accessed August 5, 2021.