Bosch has developed a new rapid test for its Vivalytic analysis device to detect Covid-19 with five simultaneous tests per cartridge. This helps tackle the major drawback of throughput and cartridge production for DNA test machines and is a world first, says the company.
The 39 minute test is currently the fastest polymerase chain reaction (PCR) test worldwide and is aimed at mobile test centres at motorway service stations or in airports to obtain a reliable result while at the testing site. The new machine is CE-approved and available in Europe now.
From early October, it will be possible to simultaneously evaluate five samples in one test cartridge and at a comparable speed, a world first according to the company. This will increase the throughput with fully automated processing of more than 160 samples a day. Optimized software to be rolled out in the next few weeks will further reduce the time to result for positive Covid-19 samples.
“One of the keys to fighting the coronavirus pandemic is to rapidly identify sources of infection. That’s why we focused on following up on our first coronavirus test with an even faster one,” says Dr. Volkmar Denner, chairman of the board of management of Robert Bosch. “This will now enable us to put people’s minds at ease even more quickly.”
The development of the new Bosch PCR singleplex test is part of a research and development project funded by the German Federal Ministry of Education and Research (BMBF).
“I believe it’s important that people have clarity about their state of health as quickly as possible. In this respect, insights from science and research can bring people huge benefits. Over the next few months, we will be confronted with the particular challenge of having to test more people,” said the German minister minister for education and research Anja Karliczek. “The improved testing procedure developed by Bosch with the BMBF’s support has the potential to be a tremendous help with this complex job. The rapid improvement of our technological capabilities shows what innovative achievements German companies can deliver in times of crisis.”
The test has a sensitivity of 98 percent and a specificity of 100 percent. To develop it, the Bosch subsidiary Bosch Healthcare Solutions joined forces with the German biotechnology company R-Biopharm – a leading provider of highly sensitive manual PCR tests. Randox Labs in northern Ireland that was the lab partner for the first version launched at the end of March after just six weeks’ development. This was a multiplex test that simultaneously checks samples for the SARS-CoV-2 virus and nine other respiratory diseases in two and a half hours.
This is comparable to the multiplex one hour test developed by DNAnudge in the UK thas has been shown a sensitivity of 94.4% accurate compared against standard NHS lab-based tests and a specificity of 100 percent to avoid false positives.
“The decentralisation of mass testing is now being recognised as the key to addressing this unprecedented public health crisis, and these results very clearly support the use of CovidNudge as a highly accurate, rapid and near-patient testing solution that can be delivered on-the-spot and at scale, in both clinical and non-clinical settings,” said Prof Chris Toumazou, CEO and co-founder of DnaNudge.
The new, accelerated test using the Biopharm reagent is exclusively for Covid-19 to reduce the test time. The platform is open and supports the Randox reagents as well as the Biopharm reagents for the faster testing and for pooled tests says Bosch.
“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 diseases with similar symptoms,” said Marc Meier, president of Bosch Healthcare Solutions.
By the end of the year, Bosch wants to reach capacity for one million tests and says it is working closely with its suppliers to maximize capacity and further increase supply of both machines and cartridges using its existing manufacturing capabilities at Bosch Healthcare Solutions at Waiblingen in Germany.
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