The FDA SARS-CoV-2 Reference Panel was first provided to all developers of authorized IVD EUAs that used contrived samples to validate their assay and is provided to all developers who request an EUA for SARS-CoV-2 NAATs. This Integrated (research and extension) project aims to protect workers' safety and assure continuation of food production through development and rapid implementation of science-based strategies to mitigate COVID-19 impacts in food production establishments. C-Saliva Such comparison has shown to be useful to healthcare providers and laboratories using these tests. A - Swabs in Transport Media** No cross-reactivity with MERS-CoV has been observed unless otherwise specified. To more precisely compare the performance of NAAT SARS-CoV-2 assays, through a collaboration between the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), the FDA established a Reference Panel composed of standardized material, suitable for the determination and direct comparison of analytical sensitivity and cross-reactivity of nucleic acid-based SARS-CoV-2 assays. *** No patient matrix was used Dry swabs are let to dry for a minimum of 20 minutes, and the swab is tested following the Instructions for Use for the device. This project addresses the program area priority: “Rapid Response to Novel Coronavirus (SARS-CoV-2) Impacts Across Food and Agricultural Systems”. Following a protocol provided by the FDA with the reference panel, developers conducted testing with 3 replicates of serial dilutions of the SARS-CoV-2 virus provided in T1 in clinical negative specimens. The panel contains one heat-inactivated SARS-CoV-2 strain and one heat-inactivated MERS-CoV strain in cell culture media. As was done for the evaluation of NAATs for Zika, the FDA is again providing a tool for a comparative analysis of the performance of different tests. This program area priority addresses the need to develop and deploy rapid, reliable, and readily adoptable strategies across the food and agriculture enterprise in response to COVID-19. The generated strategies will allow the food industry to better manage COVID-19. beef/pork and poultry) and produce farms to assure resilient food production during the COVID- 19 pandemic or other large-scale system disruptions; (2) Scale and implement facility-specific models for produce, dairy, beef/pork and poultry food establishments, that allow for in-silico assessment of possible mitigation strategies in those specific facilities; and (3) Develop and deliver a comprehensive online interactive extension program on COVID-19 control strategies that includes open industry office hours. The developed models and training-outreach platform could be adapted to manage other food system disruptions. Reference panels are a fundamental tool for performance assessment of molecular tests, and the use of the same reference material across different tests allows a direct comparison of analytical sensitivity performance across these tests. In general, FDA's EUAs require developers to evaluate and submit the analytical limit of detection and assess traceability of their product with any FDA-recommended reference material as a condition of the authorization. The COVID-19 pandemic is impacting the nation’s food and agricultural systems. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. As of September 23, 2020, the FDA has contacted developers of 186 authorized assays for shipping information and has sent the reference panel to developers of 161 authorized assays. Status of "Data not returned" indicates that no data was received as of 9/11/2020. Currently, data is needed to reliably guide decision-making that are supported by scientific evidence. Deadline Title Sponsor; Continuous until October 5, 2020: Notice of Special Interest (NOSI): Availability of Administrative Supplements and Revision … These strategies should mitigate urgent threats from the COVID-19 virus and ensure the availability of an accessible, safe, nutritious, and abundant food supply. FDA began distribution of the FDA SARS-CoV-2 Reference Panel in May 2020. To find out more information on NIH funding, please visit NIH Grants & Funding. (a Siemens Healthineers Company), George Washington University Public Health Laboratory, Gnomegen COVID-19 RT-Digital PCR Detection Kit, Gravity Diagnostics COVID-19 Assay (370KB), Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory, HealthQuest Esoterics TaqPath SARS-CoV-2 Assay, Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia, Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital, Infinity BiologiX LLC (formerly Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics - Rutgers University), Infinity BiologiX TaqPath SARS-CoV-2 Assay (formerly Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay), Inform Diagnostics SARS-CoV-2 RT-PCR Assay. Developers who received the reference panel were asked to conduct testing and return results within two weeks of receiving the panel. For example, the panel only includes one strain of SARS-CoV-2 and one cross-reactant, MERS-CoV. *** NAAT Detectable Units/ mL. While validation using these contrived specimens provided a measure of confidence in test performance at the beginning of the pandemic, it is not feasible to precisely compare the performance of various tests that used contrived specimens because each test validated performance using samples derived from different gene specific, synthetic, or genomic nucleic acid sources. Therefore, the FDA authorized IVDs based on available data from contrived samples generated from a range of SARS-CoV-2 material sources (for example, gene specific RNA, synthetic RNA, or whole genome viral RNA) for analytical and clinical performance evaluation.

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