NEW YORK – Becton Dickinson announced on Wednesday that it has obtained an expanded indication for a CE Marked immune status assay such that it can now be used to help manage patients with COVID-19. The assay, which is now available in Europe, can be used at hospital admission to determine patients at increased risk of intubation with mechanical ventilation (IMV), and mortality, the firm said.
Called the BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes, the assay is six-color direct immunofluorescence reagent for use on the BD FACSLyric and BD FACSCanto II clinical flow cytometers to 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.
The test could be especially useful in assessing the immune status of COVID-19 patients, BD said in a statement, adding published studies have demonstrated clinically validated cutoff levels and further refined the role BD Multitest 6-Color TBNK Reagent with Trucount Tubes has in determining risk of IMV and mortality at hospitalization.
Specifically, BD noted that peer-reviewed clinical studies show some patients with COVID-19 may exhibit a decrease of CD4+ and/or CD8+ T-cells, and this decrease is associated with increased risk of IMV and mortality. BD also said that results from a study it conducted showed that a COVID-19 patient's risk for IMV and mortality is five to six times higher for T-cell subsets below certain cutoff levels of compared to those that were above the cutoff.
"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.
The new indication was added In October 2020, the firm said. It specifically states that 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, and that individuals with COVID-19 disease typically exhibit a decrease of CD3+CD4+ and/or CD3+CD8+ lymphocyte counts with increasing disease severity.