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Home Drug Development

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

Content Team by Content Team
19th October 2020
in Drug Development, News
Proteostasis Therapeutics Announces In Vitro Data for PTI-129 as Potential Treatment Candidate for COVID-19

BD (Becton, Dickinson and Company), a leading global medical technology company, announced the CE mark and European availability of a product for assessing 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, an innovation in helping clinicians better understand patient immune response to COVID-19 disease. 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 6-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 prioritize precious resources.

“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, Biosciences at BD, “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.

The BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes is CE marked and is only available in the EU for COVID-19 Clinical Application.

The BD Multitest 6-Color TBNK Reagent with optional BD Trucount Tubes is a 6-color direct immunofluorescence reagent for use with a suitably equipped BD flow cytometer to identify and determine the percentages and absolute counts of T, B and natural killer (NK) cells, as well as the CD4 and CD8 subpopulations of T cells in peripheral blood. 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.

Determining counts of CD3+CD4+ and/or CD3+CD8+ lymphocytes may be useful in the immunological assessment of SARS-CoV-2 infected individuals with COVID-19 disease. Individuals with COVID-19 disease typically exhibit a decrease of CD3+CD4+ and/or CD3+CD8+ lymphocyte counts with increasing disease severity.

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