DiaSorin Molecular, Cypress, Calif, has received FDA emergency use authorization (EUA) for the company’s Simplexa Covid-19 direct kit. The kit provides a sample-to-answer test for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes covid-19, directly from nasopharyngeal swab specimens.
The Simplexa Covid-19 direct kit is designed for use on DiaSorin’s Liaison MDx analyzer. It can be utilized by hospital laboratories without the need to send the sample out, allowing for timely testing and results.
The kit contains an all-in-one reagent mix which is ready to use. Only one instrument and one reagent are required to perform the test. The kit bypasses the need for traditional extraction procedures, enabling rapid detection in a little over 1 hour—significantly faster than the up to 7 hours required by traditional extraction followed by amplification—ultimately allowing prompt decisionmaking regarding the isolation of infected patients.
The test is highly specific to covid-19 and targets several regions of the viral genome to minimize the impact on performance should there be possible future mutations. This ensures the results are highly sensitive and specific, providing confidence in diagnostic decisionmaking.
The covid-19 outbreak has now officially been declared a global pandemic by the World Health Organization, and has resulted in the United States declaring a national emergency. Many countries are currently implementing emergency quarantines and mandating social distancing in order to reduce the spread of the disease.
To develop its test, DiaSorin Molecular received federal funds from the Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA). The funding will help to increase testing capacity at hospitals across the nation, and to accelerate the availability of diagnostic testing in order to help mitigate the potential impact of the covid-19 virus.
“We are excited for the launch of our covid-19 test and hope to help reduce the current shortage of tests being experienced by hospitals worldwide,” says John Gerace, president of DiaSorin Molecular. “This test will better enable clinicians to make appropriate diagnostic decisions by providing rapid and accurate results. We know it will play a critical role in containing the pandemic.”
For further information, visit DiaSorin Molecular.