The MS-Fast system and BioCheck SARS-CoV-2 chemiluminescence tests will help detect antibodies, which indicate recent or prior Covid-19 infection
Accelerate Diagnostics has secured FDA EUA status for Covid-19 antibody testing system. (Credit: Gerd Altmann from Pixabay)
Accelerate Diagnostics and BioCheck have secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the BioCheck SARS-CoV-2 IgM and IgG Combo Test and fully-automated MS-Fast instrument.
The company will market, commercial and support the serology-based testing platform in line with its earlier disclosed commercial supply and collaboration agreement.
The tests can process human serum samples in 30 minutes
The MS-Fast system and BioCheck SARS-CoV-2 chemiluminescence tests hold the capacity to process human serum samples in 30 minutes for the detection of antibodies, which indicate recent or prior Civid-19 infection.
The BioCheck SARS-CoV-2 Combo Test Kit consists of chemiluminescent immunoassays, which qualitatively identify the content of SARS-CoV-2 IgM and IgG antibodies in human serum samples performed on the Sophonix MS-Fast automated chemiluminescent immunoassay analysing system.
The test is said to target the S1 protein, which is a crucial antigen of the novel coronavirus.
The S1 protein is also the main target for major Covid-19, vaccine candidates, which are being developed to neutralise antibodies that can restrict the virus from infecting healthy cells.
Accelerate Diagnostics CEO Jack Phillips said: This EUA will allow for more widespread adoption of the MS-Fast serology-based Covid-19 antibody testing platform.
“Serology testing is an important tool in the fight against Covid-19, as it enables the demographic and geographic surveillance necessary to guide an appropriate response to the current pandemic.”
Earlier this month, medical technology company Siemens Healthineers secured FDA EUA status for its SARS-CoV-2 IgG (COV2G) antibody test.