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COVID-19 Testing and Diagnostics: A Review of Commercialized Technologies for Cost, Convenience and Quality of Tests

DOI: 10.3390/s21196581

Subject Areas: Environmental Sciences, Medical Education, Biological Materials, Respiratory Medicine, Cell Biology, Functional Materials, Biological Chemistry, Molecular Biology, Bioinformatics, Public Health, Health Policy, Biological Engineering, Drugs & Devices, Oncology, Parasitology, Medicinal Chemistry, Global Health, Marketing, Nanometer Materials, Translational Medicine, Sales Management, Biotechnology, Infectious Diseases, Epidemiology, Virology, Bioengineering, Metabolic Sciences, Internal Medicine, Physical Chemistry, Electrochemistry, Developmental Biology, Genetics, Materials Engineering, Women’s Health, Technology And Innovation, Allergy & Clinical Immunology, Theoretical Chemistry, Immunology, Computational Biology, Supply Chain Management, Diagnostics, Information Technologies, Microbiology, Medical Genetics, Genomics, Food Science & Technology, Organic Chemistry

Keywords: COVID-19 diagnostics, COVID-19 testing, FDA, in vitro platforms, COVID-19, FDA, Food and Drug Administration, PCR, RT-PCR, UNESCO, United Nations, assay, chemical assay, commercial, commercial test, company, covid-19 patent, diagnostics, healthcare, logistics, population screening, self test, sensor, test kit, population screening, rapid testing, supply chain, survey, testing methods, mass testing, sensor, at home test, pandemic

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Abstract

Population-scale and rapid testing for SARS-CoV-2 continues to be a priority for several parts of the world. We revisit the in vitro technology platforms for COVID-19 testing and diagnostics—molecular tests and rapid antigen tests, serology or antibody tests, and tests for the management of COVID-19 patients. Within each category of tests, we review the commercialized testing platforms, their analyzing systems, specimen collection protocols, testing methodologies, supply chain logistics, and related attributes. Our discussion is essentially focused on test products that have been granted emergency use authorization by the FDA to detect and diagnose COVID-19 infections. Different strategies for scaled-up and faster screening are covered here, such as pooled testing, screening programs, and surveillance testing. The near-term challenges lie in detecting subtle infectivity profiles, mapping the transmission dynamics of new variants, lowering the cost for testing, training a large healthcare workforce, and providing test kits for the masses. Through this review, we try to understand the feasibility of universal access to COVID-19 testing and diagnostics in the near future while being cognizant of the implicit tradeoffs during the development and distribution cycles of new testing platforms.

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Benda, A. , Zerajic, L. , Ankita, A. , Cleary, E. , Park, Y. and Pandey, S. COVID-19 Testing and Diagnostics: A Review of Commercialized Technologies for Cost, Convenience and Quality of Tests. Sensors, e08734. doi: http://dx.doi.org/10.3390/s21196581.

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