The assay has been granted an expanded CE mark approval to identify and record T-cell subtypes in Covid-19 patients
Becton, Dickinson and Co. (BD) has announced the CE mark and marketing of its assay to assess immune function of Covid-19 patients, in the European Union (EU).
The assay, dubbed BD Multitest 6-Color TBNK reagent with BD Trucount Tubes, has been granted an expanded CE mark approval to identify and record T-cell subtypes in Covid-19 patients.
The medical technology firm said that its assay has been used for more than a decade to assess immune function in HIV patients and may help clinicians to better understand the immune response in Covid-19 patients.
BD biosciences worldwide president Puneet Sarin said: “The availability of this product with the expanded clinical application in COVID-19 patients is an important step in helping clinicians better understand how patient immune systems are responding to Covid-19 infection.
“BD is a trusted partner in immunology research and clinical care with a long history helping clinicians and patients better understand immune function to make patient care decisions.
“Bringing this expertise to clinicians treating Covid-19 patients presents a great opportunity to enable deeper immune assessment of patients, which could lead to improved uses of precious resources within a hospital while helping get patients on the right clinical path.”
The assay leverages established technology for immune assessment
According to the company, Covid-19 patients exhibit decreased levels of CD4 and/or CD8 lymphocytes with increase in disease severity. Precise count of T-cell subsets may help in taking clinical action, as T-cells are essential antibody response, and killing the virus.
The BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes leverages an established technology for immune assessment.
The 6-color direct immunofluorescence reagent in the assay, when use with a suitable BD flow cytometer, will identify and determine the number of T, B and natural killer (NK) cells, along with CD4 and CD8 subpopulations of T cells in peripheral blood.
The assay enables clinicians to better understand the essential mechanisms associated with disease severity in Covid-19 patients, beyond the complete blood count (CBC), said the company.
The BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes is designed for use with the BD FACSLyric and BD FACSCanto II Clinical Flow Cytometers.
When used with BD FACSLyric/BD FACSDuet Sample-to-Answer Solution, the automated processing of samples would prevent the undesired exposure for lab professionals.
The BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes can be used with the BD FACS Loader and the BD FACS Universal Loader.