On December 31, 2019, the WHO China office was informed about cases of pneumonia of unknown etiology, emerging from Wuhan city in the Hubei province of China. Between December 31 and January 3, a further 44 cases of pneumonia of unknown etiology were reported to the WHO by Chinese authorities, who had still been unable to identify the cause. Finally, on January 7, Chinese authorities were able to identify a new type of coronavirus, the 2019-nCov or the COVID-19.1 Since then, the virus has spread to all parts of the world. As of 9.30 AM (EST) on 2 April, over 900,000 cases have been reported worldwide with more than 40,000 deaths. Encouragingly, over 190,000 patients have recovered from the infection.2
Given the global impact and the potentially crippling economic consequences of this pandemic, numerous laboratories and companies worldwide have embarked upon the search to find treatments and diagnostic solutions for the COVID-19. BD, a world leader in diagnostic solutions that is committed to advancing the world of health, is also playing a pivotal role at the frontiers of this battle. On March 10, Zaragosa based CerTec Biotec and BD announced that the VIASURE SARS-CoV-2 Real-Time PCR Detection Kit adapted for the BD MAX™ System has been CE marked to the IVD Directive (98/79/CE).3 The molecular test for the detection of COVID-19 is available to clinical laboratories in countries recognizing the CE mark. The test is a real-time reverse-transcriptase polymerase chain reaction (rt-PCR) designed to work on the BD MAX™ System. It detects the COVID-19 by amplifying a fragment of the S gene of the virus. Supplied in a lyophilised format, the VIASURE kit contains in each well all the components necessary for real-time PCR assay in a stabilized format, as well as an internal control to monitor PCR inhibition.3
BD was also one of several MedTech companies that joined President Trump when he declared the coronavirus as a national emergency on the 13th of March. 4 In collaboration with BioGX Inc, BD has submitted an Emergency Use Authorisation (EUA) to the US FDA for a COVID-19 test capable of running on the BD MAX™ System.5
BD has also been exploring a point-of-care solution for the diagnosis of coronavirus leveraging on the BD Veritor™ system that is already being used to test for other respiratory diseases like influenza A, influenza B, RSV and group A Streptococcus.4 This effort is now successful, with the release of a rapid serology test to detect COVID-19.6 This new point-of-care test, that detects evidence of present and past exposure in 15 minutes, has been developed and manufactured by BioMedomics. It will be available through BD and distributed exclusively by Henry Schein, Inc. to health care providers throughout the United States. 6 The test has not been reviewed by the FDA but is permitted for distribution and use under the public health emergency guidance issued by FDA on March 16, 2020, and BD expects to begin shipping tests in April.
The role of flow cytometry
There is a crucial need to understand the mechanism of action of the COVID-19 virus and how the innate immune system reacts to it. Flow cytometry studies performed after the SARS and MERS epidemics have analysed the changes that occur in T and B lymphocytes and inflammatory response following the onset of infection.7 Very little information exists about the response of the innate immune system to the 2019-nCov virus. However, some studies have shown abnormally high plasma levels of innate cytokines (IP-10, MCP-1, MIP-1A and TNFα), or high levels of proinflammatory cytokines (IL-2, Il-7, Il-10, G‐CSF, IP‐10, MCP‐1, MIP‐1A, and TNFα).8,9 Therefore, initial data suggests that the pathogenicity of COVID-19 is similar to SARS and MERS, and is characterised by an inflammatory response and an initiation of viral sepsis due to leukocyte alterations and elevated levels of cytokines.9 However, more studies need to be carried out to understand a variety of factors like the response of other immune system components, production and utilisation of cytokines, the kinetics of humoral response and the role of T cells, B cells and regulatory T cells.9 Flow cytometry and Multi-Omics analysis will play a key role in elucidating these issues and developing vaccines and therapies in the future.
BD will continue to monitor the situation and provide regular updates on the BD website.
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Products are CE-marked in compliance with the European In Vitro Diagnostic Medical Device Directive 98/79/EC.