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BD Gets CE Mark for COVID-19 Application of Immune Function Assay

NEW YORK – Becton Dickinson announced on Friday that it has received the CE mark for an expanded clinical application of a test assess immune function in patients with COVID-19.

The BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes can now be marketed in Europe to identify and enumerate T-cell subtypes in COVID-19 patients.

It runs on the firm's FACSLyric and BD FACSCanto II Clinical Flow Cytometers as well as the BD FACSLyric/BD FACSDuet Sample-to-Answer Solutions, and consists of a six-color direct immunofluorescence reagent to identify and determine the percentages and absolute counts of T, B, and natural killer cells, as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.

Patients can exhibit decreased of CD4 and CD8 lymphocyte counts with increasing disease severity, BD noted in a statement, and accurate counts of T-cell subsets may be critical in informing the clinical course of action because T-cells are essential for killing the virus and antibody response. 

"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," said Puneet Sarin, worldwide president of biosciences at BD.

The BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes has been used for more than a decade to assess immune function in HIV patients, BD said. It now can also enable clinicians to go beyond the complete blood count, or CBC, to better understand the underlying mechanisms for severity in COVID-19 patients, especially those with co-morbidities.