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February 4, 2021

BD obtains CE mark for Covid-19 assay Multitest

Becton, Dickinson and Company (BD) has received the CE mark for its BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes.

Becton, Dickinson and Company (BD) has received the CE mark for its BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes.

The new assay helps clinicians to identify Covid-19 patients at the high relative risk of intubation with mechanical ventilation (IMV) and mortality at hospital admission in conjunction with clinical findings and other laboratory testing results.

BD noted that a better understanding of immune responses helps clinicians in determining a suitable course of action for patients while also prioritising the use of valuable hospital resources.

The direct immunofluorescence reagent can be used with BD flow cytometer for detecting and determining 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.

Last October, the clinical application for determining counts of CD3+CD4+ and / or CD3+CD8+ lymphocytes for the immunological assessment of Covid-19 was added.

Covid-19 infected individuals show a reduction in CD3+CD4+ and / or CD3+CD8+ lymphocyte counts with increasing disease severity, the company noted.

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BD Biosciences worldwide president Puneet Sarin said: “The BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes assay’s new claim related to risks of IMV and mortality may help clinicians better determine an appropriate course of action for hospitalised Covid-19 patients, which is a top priority for this population.

“BD Biosciences has a long history of helping clinicians and patients understand the immune function, and this new indication may help guide important care decisions while also prioritising resources.”

According to early publications, the BD Multitest 6-Color TBNK Reagent with Trucount Tubes was beneficial in analysing Covid-19 patients’ immune status.

Last November, BD received an order from the Canadian Government for 7.6 million point-of-care, rapid SARS-CoV-2 antigen tests and 2,172 analysers.

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