BD Announces Assay for Identification of COVID-19 Patients at Increased Relative Risks of Intubation with Mechanical Ventilation, Mortality at Hospital Admission Now Available in Europe

BD today announced the CE mark of BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes with expanded clinical application to help clinicians identify COVID-19 patients at increased relative risk of intubation with mechanical ventilation (IMV) and  mortality at hospital admission, in conjunction with clinical findings and the results of other laboratory testing.

By providing deeper understanding of immune responses, clinicians can better understand an appropriate course of action for patients while also prioritizing the use of precious hospital resources.

As an industry leader in immunology research and clinical care, BD tools were utilized for research early in the pandemic and early publications showed that the BD Multitest™ 6-Color TBNK Reagent with Trucount™ Tubes was useful in assessing immune status for COVID-19 patients. Further clinical studies have demonstrated clinically validated cut-off levels and further refined the role BD Multitest™ 6-Color TBNK Reagent with Trucount™ Tubes has along with other testing in determining the COVID-19 patients’ risk of IMV and mortality at hospitalization.

As shown in peer-reviewed clinical studies, some patients with COVID-19 may exhibit a decrease of specific lymphocyte T-cell subsets (CD4⁺ and/ or CD8⁺ T-cells), and this decrease is associated with increased risk of IMV and mortality. Knowing a patient’s accurate T-cell count, therefore, can be instrumental in informing the right course of action, and the BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes may aid in these types of determinations.

Results from a study conducted by BD have shown that a COVID-19 patient’s risk for IMV and also mortality is five to six times higher for T-cell subsets below cut-off­ levels of: CD4⁺ <250 cells/µl and/or CD8⁺ <100 cells/µl compared to those that were above the cut-off.

“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 hospitalized COVID-19 patients, which is a top priority for this population,” said Puneet Sarin, worldwide president of BD Biosciences. “BD Biosciences has a long history of helping clinicians and patients understand immune function, and this new indication may help guide important care decisions while also prioritizing resources.”

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 for COVID-19 clinical applications.

About the BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes

The BD Multitest™ 6-Color TBNK Reagent with optional BD Trucount™ Tubes is a CE marked 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.

In Oct. 2020, the following COVID-19 clinical application was added: 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.

New Clinical Application
CD3⁺CD4⁺ and/or CD3⁺CD8⁺ lymphocytes counts can also be used as an aid in determining the risk of IMV, and the risk of mortality, in confirmed COVID-19 patients, in conjunction with clinical findings and the results of other laboratory testing.