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10.1016/j.medj.2020.12.010 http://scihub22266oqcxt.onion/10.1016/j.medj.2020.12.010 33521748!7836249!33521748     free     free     free Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Med 2021 ; 2 (3): 263-280.e6 Nephropedia Template TP {{tp|p=33521748|t=2021. SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity |pdf=|usr=}}{{33521748}} gab.com Text SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity JO: Med http://www.kidney.de/pget.php?&tw=1&pmid=33521748 #FOAvip BACKGROUND: Scaling SARS-CoV-2 testing to meet demands of safe reopenings continues to be plagued by assay costs and supply chain shortages. In response, we developed SalivaDirect, which received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). METHODS: We simplified our saliva-based diagnostic test by (1) not requiring collection tubes with preservatives, (2) replacing nucleic acid extraction with a simple enzymatic and heating step, and (3) testing specimens with a dualplex qRT-PCR assay. Moreover, we validated SalivaDirect with reagents and instruments from multiple vendors to minimize supply chain issues. FINDINGS: From our hospital cohort, we show a high positive agreement (94%) between saliva tested with SalivaDirect and nasopharyngeal swabs tested with a commercial qRT-PCR kit. In partnership with the National Basketball Association (NBA) and National Basketball Players Association (NBPA), we tested 3,779 saliva specimens from healthy individuals and detected low rates of invalid (0.3%) and false-positive (<0.05%) results. CONCLUSIONS: We demonstrate that saliva is a valid alternative to swabs for SARS-CoV-2 screening and that SalivaDirect can make large-scale testing more accessible and affordable. Uniquely, we can designate other laboratories to use our sensitive, flexible, and simplified platform under our EUA (https://publichealth.yale.edu/salivadirect/). FUNDING: This study was funded by the NBA and NBPA (N.D.G.), the Huffman Family Donor Advised Fund (N.D.G.), a Fast Grant from Emergent Ventures at the Mercatus Center at George Mason University (N.D.G.), the Yale Institute for Global Health (N.D.G.), and the Beatrice Kleinberg Neuwirth Fund (A.I.K.). C.B.F.V. is supported by NWO Rubicon 019.181EN.004. Twit Text FOAVip SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity ????Med http://www.kidney.de/pget.php?&tw=1&pmid=33521748 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=33521748 #FOAvip English Wikipedia <ref>{{Cite pmid|33521748}}</ref> SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity #MMPMID33521748 Vogels CBF; Watkins AE; Harden CA; Brackney DE; Shafer J; Wang J; Caraballo C; Kalinich CC; Ott IM; Fauver JR; Kudo E; Lu P; Venkataraman A; Tokuyama M; Moore AJ; Muenker MC; Casanovas-Massana A; Fournier J; Bermejo S; Campbell M; Datta R; Nelson A; Dela Cruz CS; Ko AI; Iwasaki A; Krumholz HM; Matheus JD; Hui P; Liu C; Farhadian SF; Sikka R; Wyllie AL; Grubaugh ND Med 2021[Mar]; 2 (3): 263-280.e6 PMID33521748show ga BACKGROUND: Scaling SARS-CoV-2 testing to meet demands of safe reopenings continues to be plagued by assay costs and supply chain shortages. In response, we developed SalivaDirect, which received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). METHODS: We simplified our saliva-based diagnostic test by (1) not requiring collection tubes with preservatives, (2) replacing nucleic acid extraction with a simple enzymatic and heating step, and (3) testing specimens with a dualplex qRT-PCR assay. Moreover, we validated SalivaDirect with reagents and instruments from multiple vendors to minimize supply chain issues. FINDINGS: From our hospital cohort, we show a high positive agreement (94%) between saliva tested with SalivaDirect and nasopharyngeal swabs tested with a commercial qRT-PCR kit. In partnership with the National Basketball Association (NBA) and National Basketball Players Association (NBPA), we tested 3,779 saliva specimens from healthy individuals and detected low rates of invalid (0.3%) and false-positive (<0.05%) results. CONCLUSIONS: We demonstrate that saliva is a valid alternative to swabs for SARS-CoV-2 screening and that SalivaDirect can make large-scale testing more accessible and affordable. Uniquely, we can designate other laboratories to use our sensitive, flexible, and simplified platform under our EUA (https://publichealth.yale.edu/salivadirect/). FUNDING: This study was funded by the NBA and NBPA (N.D.G.), the Huffman Family Donor Advised Fund (N.D.G.), a Fast Grant from Emergent Ventures at the Mercatus Center at George Mason University (N.D.G.), the Yale Institute for Global Health (N.D.G.), and the Beatrice Kleinberg Neuwirth Fund (A.I.K.). C.B.F.V. is supported by NWO Rubicon 019.181EN.004. |*COVID-19/diagnosis[MESH] |*SARS-CoV-2/genetics[MESH] |COVID-19 Testing[MESH] |Humans[MESH] |Laboratories[MESH]SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2(epmc).pdf DeepDyve Pubget Overpricing