BD announces an IVD immune assay application that can aid in patient management decisions in COVID-19

New Delhi, May 21, 2021: In a major development, BD (Becton, Dickinson and Company), a leading global medical technology company, announced the availability of its BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes with an expanded clinical application in India, to help identify COVID-19 patients at the increased relative risk of intubation with mechanical ventilation (IMV) and mortality, 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.

Speaking on the importance of gauging the patient’s immunity profile, Pavan Mocherla, Managing Director, BD India/South Asia, says, “As India continues to battle with this unprecedented healthcare crisis in the wake of the second wave of COVID-19, application of this immune assessment-based IVD assay amongst COVID-19 patients could potentially ease out the already choked healthcare infrastructure in the country by prioritizing hospital admission and ICU beds to those who are at higher relative risk for requiring ventilator support, and increased risk of mortality”.

“BD has a long working experience with CD4 Monitoring for HIV patients through NACO, MOH&FW, Govt of India in the country. We have been supporting researchers and clinicians to understand immune functions in Cancer, Primary Immuno Deficiency and COVID-19 Vaccine research as well. We hope that that availability of this assay kit in India for expanded COVID-19 clinical application helps in optimal utilization of hospital resources,” adds Pavan Mocherla.

The kit, which is approved for use in European Union, has been reviewed and approved by Drug Controller (General) India CDSCO, India to monitor the lymphocyte subsets for various applications. The test is conducted on a clinical flow cytometer which are available with major hospitals and network laboratories across India. In the current scenario of COVID-19 crisis, this information can now equip the clinician with a deeper understanding of the patient’s immune status3.

India has approximately 1.9 million hospital beds, 95,000 ICU beds, and 48,000 ventilators1. Considering the COVID-19 trend and the possibility of multiple waves in future, some research projections estimate a potential requirement of nearly 2,70,000 ICU beds which is over 2.8 times the estimated number of total available ICU beds in India2. A major percentage of these may further require ventilators. This puts an insurmountable amount of pressure on the limited resources since the influx of patients into the hospitals is manifold. The situation across India in April 2021 was testimony for the same.

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.

About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers.
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References
1. https://cddep.org/blog/posts/weekly-digest-april-27-2020/
2. https://www.medrxiv.org/content/10.1101/2020.06.16.20132787v1.full.pdf (pg 2)
3. Lymphocyte Subset Counts in COVID-19 Patients: A Meta-Analysis: https://pubmed.ncbi.nlm.nih.gov/32542842/