biostudies-literatureMa LNational High Level Hospital Clinical Research Funding8053524https://www.ebi.ac.uk/biostudies/studies/S-EPMC9883100biostudies-literatureUnknown2023<h4>Objectives</h4>To establish and evaluate the analytical and clinical performance of the Flash20 SARS-CoV-2 nucleic acid rapid detection system free of RNA extraction.<h4>Methods</h4>The limit of detection (LoD) was determined using a negative nasopharyngeal swab matrix spiked with different concentrations of SARS-CoV-2 virus; a total of 734,337 reference sequences of viral genomes from GenBank were used for the in-silico analysis to assess the inclusivity of the assay. The specificity of the system was evaluated by testing 27 medically relevant organisms. A total of 115 clinical specimens were collected and tested on the Flash20 SARS-CoV-2 detection system and with an FDA-approved comparator test to assess the clinical performance of the system.<h4>Results</h4>The LoD of the Flash20 SAInternational journal of analytical chemistryFast and Sensitive Detection of SARS-CoV-2 Nucleic Acid Using a Rapid Detection System Free of RNA Extraction.PMC98831002020ZRJY2021-GG0382074221Jiang YLiu YZhao MGao PMa LFan YCui YHuang HCao YKong XfalseFast and Sensitive Detection of SARS-CoV-2 Nucleic Acid Using a Rapid Detection System Free of RNA Extraction.<h4>Objectives</h4>To establish and evaluate the analytical and clinical performance of the Flash20 SARS-CoV-2 nucleic acid rapid detection system free of RNA extraction.<h4>Methods</h4>The limit of detection (LoD) was determined using a negative nasopharyngeal swab matrix spiked with different concentrations of SARS-CoV-2 virus; a total of 734,337 reference sequences of viral genomes from GenBank were used for the in-silico analysis to assess the inclusivity of the assay. The specificity of the system was evaluated by testing 27 medically relevant organisms. A total of 115 clinical specimens were collected and tested on the Flash20 SARS-CoV-2 detection system and with an FDA-approved comparator test to assess the clinical performance of the system.<h4>Results</h4>The LoD of the Flash20 SA2023-01-01T00:00:00Z20232026-07-15T22:31:28.167Z2025-04-06T14:11:36.339ZS-EPMC98831003671417310.1155/2023/8053524