Description

New 39-minute COVID test available on Randox-Bosch Vivalytic

• The world’s fastest PCR based SARS-CoV-2 test for the point of care delivers reliable results in 39 minutes.
• Has a sensitivity of 98 percent and a specificity of 100 percent.
• Simultaneous testing of five people with one cartridge by pooling will be available from early October.
• Work is in progress to further reduce time to result.

A rapid new coronavirus test, which provides results for Covid-19 in just 39 minutes, is now available on the Vivalytic, a point of care platform brought to market by Randox Laboratories and Bosch.

The test for detection of the SARS-CoV-2 pathogen, is currently the fastest PCR test (the gold standard of test methods) worldwide, and is predestined for decentralized use in mobile test centres at service stations or in airports, so that people who take the test can obtain a reliable result while at the testing site.

Available now in Europe, the CE-approved test, which has a sensitivity of 98 percent and a specificity of 100 percent, helps avoid time in quarantine, relieve laboratories, and make travel and work safer again.

“Rapid and accurate testing plays a crucial role in identifying cases of Covid-19 – to contain any outbreaks and limit the spread of the virus,” says Dr. Heather McMillan, Molecular R&D Manager at Randox Biosciences.

 “This new rapid test will be a game-changer in the coronavirus testing landscape by allowing patients to receive their results at the point of care faster than ever before.”

Randox and Bosch launched the first rapid test for the Vivalytic analyser at the end of March, after just six weeks’ development.

As a multiplex test, it simultaneously checks samples for the SARS-CoV-2 virus as well as nine other respiratory diseases in two and a half hours, whereas the new accelerated test is exclusively for SARS-CoV-2.

“With our different coronavirus tests and variable analysis strategies, we open up a range of testing scenarios with a Vivalytic device – from screening all the way to supporting differential diagnosis for similar symptoms,” says Marc Meier, president of Bosch Healthcare Solutions GmbH.

And development work for Covid tests on the Vivalytic is ongoing: as of early October 2020, by pooling samples together it will be possible to simultaneously evaluate five samples in one test cartridge and at a comparable speed – a world first.

This will increase available testing capacity, by enabling fully automated processing of more than 160 samples a day using a Vivalytic device.

Key Benefits of SARS-CoV-2 test on Vivalytic point of care platform

The advantages of the rapid SARS-CoV-2 test on Vivalytic lie not only in speedy analysis, but also in ease of use. A sample is taken from the nose or throat using a swab, and placed in the test cartridge. Then the cartridge, which contains all the reagents required for the test, is inserted into the Vivalytic device for automated analysis.

• Turnaround time of 39 mins from sample entry to result.
• The SARS-CoV-2 rapid test has recently received CE marking.
• The SARS-CoV-2 pooling test can run up to 5 samples on-board one single cartridge.
• Easy 4-step user-friendly process from sample entry to result. Minimal training required.
• Detection from real-time PCR from Nasopharyngeal and/or Oropharyngeal swab.
• Suitable for use in any laboratory and non-laboratory settings.

The development of the new Vivalytic PCR singleplex test is part of a research and development project funded by the German Federal Ministry of Education and Research (BMBF).