ABSTRACT
The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has had severe consequences for health and the global economy. To control the transmission, there is an urgent demand for early diagnosis and treatment in the general population. In the present study, an automatic system for SARS-CoV-2 diagnosis is designed and built to deliver high specification, high sensitivity, and high throughput with minimal workforce involvement. The system, set up with cross-priming amplification (CPA) rather than conventional reverse transcription-polymerase chain reaction (RT-PCR), was evaluated using more than 1000 real-world samples for direct comparison. This fully automated robotic system performed SARS-CoV-2 nucleic acid-based diagnosis with 192 samples in under 180 min at 100 copies per reaction in a "specimen in data out" manner. This throughput translates to a daily screening capacity of 800-1000 in an assembly-line manner with limited workforce involvement. The sensitivity of this device could be further improved using a CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats)-based assay, which opens the door to mixed samples, potentially include SARS-CoV-2 variants screening in extensively scaled testing for fighting COVID-19.
Subject(s)
COVID-19 Nucleic Acid Testing/methods , COVID-19/diagnosis , SARS-CoV-2 , Algorithms , Biomedical Engineering/instrumentation , Biomedical Engineering/methods , Biomedical Engineering/statistics & numerical data , COVID-19/epidemiology , COVID-19/virology , COVID-19 Nucleic Acid Testing/instrumentation , COVID-19 Nucleic Acid Testing/statistics & numerical data , Clustered Regularly Interspaced Short Palindromic Repeats , Equipment Design , High-Throughput Screening Assays/instrumentation , High-Throughput Screening Assays/methods , High-Throughput Screening Assays/statistics & numerical data , Humans , Nucleic Acid Amplification Techniques/instrumentation , Nucleic Acid Amplification Techniques/methods , Nucleic Acid Amplification Techniques/statistics & numerical data , Pandemics , Robotics/instrumentation , Robotics/methods , Robotics/statistics & numerical data , SARS-CoV-2/genetics , Sensitivity and Specificity , Systems AnalysisABSTRACT
As the scope and scale of the COVID-19 pandemic became clear in early March of 2020, the faculty of the Malone Center engaged in several projects aimed at addressing both immediate and long-term implications of COVID-19. In this article, we briefly outline the processes that we engaged in to identify areas of need, the projects that emerged, and the results of those projects. As we write, some of these projects have reached a natural termination point, whereas others continue. We identify some of the factors that led to projects that moved to implementation, as well as factors that led projects to fail to progress or to be abandoned.
Subject(s)
Biomedical Engineering , COVID-19/prevention & control , Biomedical Engineering/instrumentation , Biomedical Engineering/methods , Biomedical Engineering/organization & administration , Databases, Factual , Humans , Nebraska , Pandemics , SARS-CoV-2ABSTRACT
In the last decade, only 24% of class III life-saving devices approved by the U.S. Food and Drug Administration (FDA) were for pediatric use-and most of those were for children over 12. Of these, less than 4% were labeled for pediatric patients ages 0-2 years old and the number of approved devices is even lower for neonatal patients. For these young patients, adult medical devices are often manipulated by pediatric specialists in order to provide stop-gap solutions. However, these repurposed devices are not always able to fulfill the unique needs of children's biology and growth patterns.
Subject(s)
Biomedical Engineering/instrumentation , Equipment Design , Pediatrics/instrumentation , Child , Child, Preschool , Device Approval , Humans , Infant , Infant, Newborn , Inventions , United States , United States Food and Drug AdministrationABSTRACT
The COVID-19 pandemic has affected life for everyone, and hospitals, in particular have been hard hit. In this study, we describe our efforts to develop personal protective equipment at a children's hospital early in the pandemic. We convened an innovation working group to organize our efforts and respond to the rapidly changing situation. We describe our work in four areas: (1) plexiglass shields for the emergency department, (2) face shields for clinical providers, (3) breath shields for ophthalmology, and (4) flip-up safety glasses for nurses. The hospital's supply chain is now caught up with addressing many pandemic-related shortages. Nevertheless, through our multidisciplinary approach to reacting to the pandemic's urgent needs, we demonstrated agility to bring stakeholders together to maximize the use of scarce resources and build resiliency. We believe this method can be rapidly replicated as future needs arise.
Subject(s)
Biomedical Engineering/instrumentation , COVID-19/prevention & control , Hospitals, Pediatric , Inventions , Personal Protective Equipment , Emergency Service, Hospital , Equipment Design , Humans , Pandemics , SARS-CoV-2ABSTRACT
At this time many (if not all) colleges and universities are on lockdown, students have returned home, and classes have transitioned to online instruction. Students in capstone design courses around the country have no access to their school's maker spaces and test equipment. Their prototype parts may be stored in a locked maker space, making it difficult to build, test, and deliver prototypes to sponsors or clients at the end of the semester.z.