DiaSorin announced on Saturday 18 September “the launch of the new Simplexa ™ COVID-19 & Flu A / B Direct test in countries that accept CE marking”. This is what is stated in the press release issued by the group.
“The test allows for qualitative identification and the
in vitro differentiation of SARS-CoV-2 RNA segments and influenza A and B viruses. The test is approved for use on the LIAISON® MDX platform, is performed directly on the sample collected via nasopharyngeal swab without requiring any process extraction and will be submitted to the US Food and Drug Administration for 510 (k) approval. “.
The note also states that “Simplexa ™ COVID-19 & Flu A / B Direct guarantees high reliability of results thanks to its ability to detect a wide range of virus variants. In particular, the test is approved for
the identification of more than 80 influenza virus variants (including all those identified by the CDC
in the last 3 years) and is able to identify the SARS-CoV-2 virus even in new variants
emerged, including Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2), Epsilon
(B.1.427/B.1.429), the Zeta (P.2), the Eta (B.1.525), the Iota (B.1.526), the Kappa (B.1.617.1), the Lambda (C.37 ) to be
la Mu (B.1.621)”.
Again, Diasorin:
“The number of cases of flu during the 2020/2021 season was extremely small: this entails
a reduced degree of immunity of the population compared to previous years and therefore a greater risk of spreading during the next flu season. The Simplexa ™ COVID-19 & Flu A / B Direct Test offers laboratories the ability to identify the viruses that most frequently cause respiratory disease during the flu season with a single test. This aspect has an even higher relevance in the current context, in which distinguishing the cause of infection in a patient only on the basis of the clinical manifestation of the pathology is particularly complex. The timely identification of the virus causing the infection is in fact essential for the management of the therapies to which the patient is subjected and for the application of the correct prophylaxis to avoid the spread of the virus “.
So Michelle Tabb, Chief Scientific Officer of DiaSorin Molecular:
“The extension of our molecular product offering with the launch of this kit for the combined detection of influenza and SARS-CoV-2 viruses further enriches our test menu in response to the expected critical issues that will emerge during the next flu season The new multiplex molecular test launched
today, in addition to the existing test for the identification of COVID-19 and the combined test for diagnosis
differential of influenza virus types A, B and RSV, will provide laboratories with valuable support in
fight against the pandemic towards the desired return to normality “