Dataset Information

Rapid Implementation of Severe Acute Respiratory Syndrome Coronavirus 2 Emergency Use Authorization RT-PCR Testing and Experience at an Academic Medical Institution.

ABSTRACT: An epidemic caused by an outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in China in December 2019 has since rapidly spread internationally, requiring urgent response from the clinical diagnostics community. We present a detailed overview of the clinical validation and implementation of the first laboratory-developed real-time RT-PCR test offered in the NewYork-Presbyterian Hospital system following the Emergency Use Authorization issued by the US Food and Drug Administration. Validation was performed on nasopharyngeal and sputum specimens (n = 174) using newly designed dual-target real-time RT-PCR (altona RealStar SARS-CoV-2 Reagent) for detecting SARS-CoV-2 in upper respiratory tract and lower respiratory tract specimens. Accuracy testing demonstrated excellent assay agreement between expected and observed values and comparable diagnostic performance to reference tests. The limit of detection was 2.7 and 23.0 gene copies per reaction for nasopharyngeal and sputum specimens, respectively. Retrospective analysis of 1694 upper respiratory tract specimens from 1571 patients revealed increased positivity in older patients and males compared with females, and an increasing positivity rate from approximately 20% at the start of testing to 50% at the end of testing 3 weeks later. Herein, we demonstrate that the assay accurately and sensitively identifies SARS-CoV-2 in multiple specimen types in the clinical setting and summarize clinical data from early in the epidemic in New York City.

SUBMITTER: Velu P

PROVIDER: S-EPMC7718583 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Rapid Implementation of Severe Acute Respiratory Syndrome Coronavirus 2 Emergency Use Authorization RT-PCR Testing and Experience at an Academic Medical Institution.

Velu Priya P Craney Arryn A Ruggiero Phyllis P Sipley John J Cong Lin L Hissong Erika M EM Loda Massimo M Westblade Lars F LF Cushing Melissa M Rennert Hanna H

The Journal of molecular diagnostics : JMD 20201205 2

An epidemic caused by an outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in China in December 2019 has since rapidly spread internationally, requiring urgent response from the clinical diagnostics community. We present a detailed overview of the clinical validation and implementation of the first laboratory-developed real-time RT-PCR test offered in the NewYork-Presbyterian Hospital system following the Emergency Use Authorization issued by the US Food and Drug Administr ...[more]

PMID: 33285285

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Project description:Introduction:Emergency Medicine is a medical specialty based on knowledge and skills required for the prevention, diagnosis and management of the acute and urgent aspects of illness and injury affecting patients of all age groups with a full spectrum of undifferentiated physical and behavioural disorders. Addis Ababa University School of Medicine started its Emergency Medicine Residency in 2010 and Emergency Medicine training for fourth-year medical students started in 2013. This study aims to assess attitudes of fifth year medical students towards Emergency Medicine training and its contribution to their final year of medical school training. Methods:Two hundred fifth year medical students participated in the study by convenience sampling. Self-administered questionnaires and Likert scales were used for data collection. Descriptive frequencies and chi-square analysis were done for categorical data. Ethical oversight was provided by the Institutional Review Board of the Addis Ababa University College of Health Sciences. Results:Of the 200 participants, 150 were male and 50 were female. 80% agreed its relevance for undergraduates. Relevance was significantly associated with recommendation to other medical schools (? 2 = 8.34, Pr = 0.004). 72% of respondents agreed lectures are appropriate teaching methods, 70% agreed group activity, 68.5% skill sessions, 67.5% morning discussions, 64% diagnostic session, 60% duty exposures and 45% seminars. Difficulties faced during internship are primarily attributed to lack of facilities, ranging from the setup of the emergency centre to instruments and emergency drugs. 60% of respondents agreed that Emergency Medicine training is important to future careers. 65% agreed recommending training to other medical schools. Conclusion:An Emergency Medicine rotation during the final year of medical school provides opportunities to learn about undifferentiated medical emergencies and it should be included for other medical schools in the country. Participants suggest that leadership aspects of Emergency Medicine need more emphasis as the curriculum is further developed in the future.

Dataset Information

Rapid Implementation of Severe Acute Respiratory Syndrome Coronavirus 2 Emergency Use Authorization RT-PCR Testing and Experience at an Academic Medical Institution.

Publications

Rapid Implementation of Severe Acute Respiratory Syndrome Coronavirus 2 Emergency Use Authorization RT-PCR Testing and Experience at an Academic Medical Institution.

Similar Datasets

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