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Roche recently announced that it will launch a new coronavirus rapid antigen testing product, SARS-CoV-2 Rapid Antigen Test, in the market for CE marking at the end of September.
, the company intends to apply to the FDA for emergency use authorization (EUA).
This fast antigen detection product can be used for bedside care for asymptomatic and asymptomatic COVID-19 patients, which helps healthcare professionals quickly identify SARS-CoV-2 infections in individuals suspected of carrying SARS-CoV-2 virus.
addition, this fast antigen detection product provides a valuable initial screening product for people who have been exposed to SARS-CoV-2 infections or at high risk of remission.
this product uses a rapid chromatography immunoanalytic method for qualitatively detecting SARS-CoV-2 specific antigens present in nasopharyngeal swabs.
The product, which is used by healthcare professionals to detect nasopharyngeal swabs collected from suspected individuals, is designed to help patients with SARS-CoV-2 clinical symptoms diagnose SARS-CoV-2 infection at an early stage, as well as to help conduct initial screening of patients to quickly identify infected people.
is affordable, small and requires no instrumentation and can be used in a variety of environments, including bedside care and resource-limited locations.
, it can give test results in 15 minutes.
test data from 426 samples from two independent research centres showed that the sensitivity of the product was 96.52 per cent (positive compliance rate) and specificity 99.68 per cent (negative compliance rate).
said it would provide 40m fast antigen testing products a month to the market.
capacity will more than triple by the end of this year to help meet the testing needs of the global healthcare system.
it's worth noting that a week ago, a COVID-19 fast antigen detection card from Abbott, BinaxNOW COVID-19 Ag Card, was awarded EUA by the FDA.
test card allows qualitative testing of SARS-CoV-2 nuclear shell protein antigens from nasal swabs in suspected COVID-19 patients.
test card costs just $5 and uses Abbott's proven lateral flow technology to produce results in 15 minutes without any instrumentation, with a sensitivity of 97.1 per cent and a specificity of 98.5 per cent.
the U.S. government signed a $760 million procurement agreement with Abbott shortly after it received the EUA, with plans to purchase 150 million test cards.
that Roche could be a big winner in the big two markets in the US and Europe.
's first focus on Europe will allow the company to get a large number of orders from European governments, while Abbott's fast-track products will be procured mainly by the US government in 2020.
the popularity of COVID-19, there is a huge demand for fast-track products in the United States, and if Roche gets EUA, it has a chance to get orders from the U.S. government.
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