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 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.”