BD announces assay for identification of COVID-19 patients at increased relative risks of intubation
3 Feb 2021BD Biosciences has 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.
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.
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BD FACSCanto II
BD BiosciencesCell analyzer with proven reliability The BD FACSCanto™ family of benchtop analyzers features reliable performance and accurate results for experiments requiring up to 10 parameters. Numerous innovations make the system easy to use, powerful, and productive. A fixed alignment flow cell, for example, minimizes startup time and improves reproducibility. And a patented optical design maximizes signal detection and increases sensitivity and resolution for each color in a multicolor assay. High Performance, Innovative System The BD FACSCanto™ II system features many innovations. At the heart of the cytometer, for example, the fluidics system features a fixed-alignment flow cell to minimize startup time and improve reproducibility. The BD FACSCanto II fluidics system is designed to streamline work, save time, and improve performance. In the fluidics system, the sample travels up the sample injection tube, and hydrodynamic focusing within the flow cell forces particles into a single-file stream where laser light intercepts the stream at the sample interrogation point. The unique flow cell design permits particles to flow through the center of the flow cell. Increasing the sample pressure increases the core diameter and the flow rate. Fluidics cart A fluidics cart holds large fluid tanks necessary to operate and maintain the instrument. For sample acquisition, positive-pressure pumps in the fluidics cart send sheath fluid past a 0.2-μm filter to a pressurized interior reservoir inside the instrument called the plenum. The plenum maintains a nearly constant fluid level and dampens pump pulsation using a new dynamic feedback pressure control system designed to regulate pressure. As a result, sheath flow rate does not vary with the level of fluid in the sheath cubitainer, and the reservoir automatically removes small air bubbles from the sheath supply. Hydrodynamic focusing A high flow rate is generally used for measurements such as immunophenotyping, for which data is less resolved but is acquired more quickly. A lower flow rate is generally used in applications for which optimal resolution and sensitivity are critical. Software Daily routine procedures such as startup, shutdown, and cleaning routine cycles are automated as a result of fluidic integration with BD FACSCanto clinical software or BD FACSDiva™ software. BD FACS™ shutdown solution prevents salt crystal buildup in fluidics lines and is supplemented with a preservative to prevent bacterial growth. During the instrument shutdown procedure, BD FACS shutdown solution replaces sheath fluid in all sample and sheath fluid lines. LED alerts LEDs are located in the front door to monitor each acquisition parameter. Each LED blinks when the signal level reaches a prescribed threshold.
