![]() ![]() ![]() From an industry perspective, developing, validating, manufacturing, and finally commercializing a diagnostic assay is an elaborate and complex process that requires interdepartmental collaboration, detailed planning, and effective time management. On January 10, 2020, the viral genome sequence for SARS-CoV-2 was released for immediate public health support, and since then, hundreds of diagnostic assays have been developed commercially for the rapid detection of the novel coronavirus (Wuhan-Hu-1, GenBank accession number MN908947). Challenges in Research And Developmentĭuring the COVID-19 pandemic, rapid and accurate diagnosis of the causative pathogen in both symptomatic and asymptomatic patients was particularly critical, as it supported appropriate patient cohorting, quarantine duration, and subsequent therapy and treatment ( Rosenthal, 2020). In this perspective article, we describe the unique challenges faced by the diagnostic industry during the COVID-19 pandemic, particularly focusing on the difficulties encountered by Luminex, and discuss the possible strategies that can be implemented to tackle future pandemics. Additionally, using Luminex’s xMAP ® Technology, users can perform a wide range of protein- and nucleic acid-based multiplex assays, which can simultaneously detect up to 500 targets in a single reaction. The company offers both targeted and syndromic molecular testing panels for different disease states. Luminex ® Corporation is a diagnostic assay development and manufacturing company located in Austin, Texas that offers a wide range of products for clinical diagnostics and biomedical research. ![]() Additionally, the constant change in the available information and guidance from regulatory agencies created further confusion that required constant communication and monitoring of the ongoing pandemic. However, due to the unprecedented nature of the pandemic, the industry overall encountered tremendous challenges in terms of the available workforce, production capacity, and ongoing supply chain issues. All diagnostic companies worked towards a common goal – bringing about a highly sensitive and specific test rapidly in the market and making it accessible to clinical laboratories to meet patient needs and guide the isolation practices for potentially infectious individuals. Manufacturers of diagnostic assays witnessed a rapid escalation in their research and development efforts to develop tests for SARS-CoV-2. Rapid diagnosis and testing was paramount for allocating hospital resources, appropriate patient cohorting, administering effective therapeutic measures, and implementing adequate quarantining procedures ( Rosenthal, 2020). During the early days of the pandemic, hospitals and emergency centers were overpopulated with patients, resulting in an insufficient number of available beds and personnel, as well as an immense upsurge in need for diagnostic testing kits for identifying the SARS-CoV-2 virus, which were not yet readily available ( Centers for Disease Control and Prevention, 2020). The pandemic not only overburdened the healthcare system but it has also significantly affected the in-vitro diagnostic industry. The coronavirus-19 (COVID-19) pandemic has posed unprecedented global challenges to a multitude of sectors and industries. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |