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BD receives CE mark for COVID-19 immune function test

BD receives CE mark for COVID-19 immune function test

BD (Becton, Dickinson and Company) has received the CE mark for a product that assesses immune function in COVID-19 patients.

The BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes has been CE marked with expanded clinical application for the identification and enumeration of T-cell subtypes in COVID-19 patients. Data from the first global wave of COVID-19 have shown that patients typically exhibit a remarkable decrease of CD4 and/or CD8 lymphocyte counts with increasing disease severity.

Accurate counts of T-cell subsets may be critical in informing the clinical course of action because T-cells are essential for viral killing and antibody response. The BD Multitest-Color TBNK Reagent with BD Trucount Tubes leverages time-tested technology for immune assessment and enables clinicians to go beyond the complete blood count (CBC) to better understand the underlying mechanisms for severity in COVID-19 patients, especially those with co-morbidities. This test has been used for more than a decade to assess immune function in HIV patients and may now also help clinicians better understand COVID-19 patient immune response, and when used in conjunction with clinical findings and laboratory testing, inform patient treatment plans and prioritise precious resources. 

Puneet Sarin, worldwide president, biosciences at BD, 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 BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes is used in conjunction with the BD FACSLyric and BD FACSCanto II Clinical Flow Cytometers and the BD FACSLyric/BD FACSDuet Sample-to-Answer Solution, which enables automated processing of samples, removing any unnecessary exposure to lab personnel. 

Med-Tech Innovation

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