Ultra-Fast, Fully Automated SARS-CoV-2 Virus Detection Test Uniquely Suited for Near Patient Testing

(Warsaw, Poland), the PCR|ONE SARS-CoV-2 panel is now CE-marked and can be introduced to the European market. The PCR|ONE SARS-CoV-2 panel uniquely combines several key parameters such as ease of use, affordable cost, very short testing time and informativeness.

Among all the rapid genetic tests for SARS-CoV-2, the PCR|ONE test is the most reliable method of detecting SARS-CoV-2 and also one the fastest on the market. A number of testing locations will benefit from the system’s unique performance, especially where fast and accurate diagnosis is important – from medical centers to any location frequented by the public.

The PCR|ONE system for SARS-CoV-2 virus detection successfully passed in-depth testing in external hospital laboratories, achieving very high values for the most relevant clinical parameters: 91.2% sensitivity and 100% specificity. On the other hand, in the analysis of samples containing higher amounts of viral RNA (samples from patients likely to infect other people), the PCR|ONE system proved flawless, obtaining 100% sensitivity and 100% specificity. PCR|ONE with the SARS-CoV-2 panel was also tested the PCR|ONE system at the Warsaw Chopin Airport, where passengers from almost all over the world arrive.

“PCR|ONE is designed to test for a number of targets in the SARS-CoV-2 genome,” said Vincent Linder, Ph.D., author of more than 300 patents in microfluidic techniques and point-of-care diagnostics, founder of a diagnostics startup at Harvard University, and member of the Scope Fluidics Board of Experts. “As such it can be easily adapted to include new genetic targets to timely address the threat posed by new variants of the virus. It is a system that has an enormous growth potential – as a powerful tool to fight the COVID-19 pandemic and also a number of other conditions where a timely diagnosis allows for rapid initiation of treatment and improvement in patient outcome.”

“We have demonstrated the versatility of the PCR|ONE system. We knew that it could be used to identify bacterial DNA along with checking their antibiotic susceptibility. Now we know that it can also be used to identify virtually any pathogen in the world. This will open way for a very broad application of the PCR|ONE system in medical diagnostics,” said Dr. Kamil Gewartowski, PCR|ONE project manager at Scope Fluidics.

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Scope Fluidics S.A.