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10.1128/JCM.01669-20 http://scihub22266oqcxt.onion/10.1128/JCM.01669-20 32727828!7512162!32727828     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=32727828&cmd=llinks): Failed to open stream: HTTP request failed! 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Performance Characteristics of a High-Throughput Automated Transcription-Mediated Amplification Test for SARS-CoV-2 Detection |pdf=|usr=}}{{32727828}} gab.com Text Performance Characteristics of a High-Throughput Automated Transcription-Mediated Amplification Test for SARS-CoV-2 Detection JO: J Clin Microbiol http://www.kidney.de/pget.php?&tw=1&pmid=32727828 #FOAvip The COVID-19 pandemic caused by the new SARS-CoV-2 coronavirus has imposed severe challenges on laboratories in their effort to achieve sufficient diagnostic testing capability for identifying infected individuals. In this study, we report the analytical and clinical performance characteristics of a new, high-throughput, fully automated nucleic acid amplification test system for the detection of SARS-CoV-2. The assay utilizes target capture, transcription-mediated amplification, and acridinium ester-labeled probe chemistry on the automated Panther system to directly amplify and detect two separate target sequences in the open reading frame 1ab (ORF1ab) region of the SARS-CoV-2 RNA genome. The probit 95% limit of detection of the assay was determined to be 0.004 50% tissue culture infective dose (TCID(50))/ml using inactivated virus and 25 copies/ml (c/ml) using synthetic in vitro transcript RNA targets. Analytical sensitivity (100% detection) was confirmed to be 83 to 194 c/ml using three commercially available SARS-CoV-2 nucleic acid controls. No cross-reactivity or interference was observed with testing of six related human coronaviruses, as well as 24 other viral, fungal, and bacterial pathogens, at high titers. Clinical nasopharyngeal swab specimen testing (n = 140) showed 100%, 98.7%, and 99.3% positive, negative, and overall agreement, respectively, with a validated reverse transcription-PCR nucleic acid amplification test (NAAT) for SARS-CoV-2 RNA. These results provide validation evidence for a sensitive and specific method for pandemic-scale automated molecular diagnostic testing for SARS-CoV-2. Twit Text FOAVip Performance Characteristics of a High-Throughput Automated Transcription-Mediated Amplification Test for SARS-CoV-2 Detection ????J Clin Microbiol http://www.kidney.de/pget.php?&tw=1&pmid=32727828 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=32727828 #FOAvip English Wikipedia <ref>{{Cite pmid|32727828}}</ref> Performance Characteristics of a High-Throughput Automated Transcription-Mediated Amplification Test for SARS-CoV-2 Detection #MMPMID32727828 Pham J; Meyer S; Nguyen C; Williams A; Hunsicker M; McHardy I; Gendlina I; Goldstein DY; Fox AS; Hudson A; Darby P; Hovey P; Morales J; Mitchell J; Harrington K; Majlessi M; Moberly J; Shah A; Worlock A; Walcher M; Eaton B; Getman D; Clark C J Clin Microbiol 2020[Sep]; 58 (10): ä PMID32727828show ga The COVID-19 pandemic caused by the new SARS-CoV-2 coronavirus has imposed severe challenges on laboratories in their effort to achieve sufficient diagnostic testing capability for identifying infected individuals. In this study, we report the analytical and clinical performance characteristics of a new, high-throughput, fully automated nucleic acid amplification test system for the detection of SARS-CoV-2. The assay utilizes target capture, transcription-mediated amplification, and acridinium ester-labeled probe chemistry on the automated Panther system to directly amplify and detect two separate target sequences in the open reading frame 1ab (ORF1ab) region of the SARS-CoV-2 RNA genome. The probit 95% limit of detection of the assay was determined to be 0.004 50% tissue culture infective dose (TCID(50))/ml using inactivated virus and 25 copies/ml (c/ml) using synthetic in vitro transcript RNA targets. Analytical sensitivity (100% detection) was confirmed to be 83 to 194 c/ml using three commercially available SARS-CoV-2 nucleic acid controls. No cross-reactivity or interference was observed with testing of six related human coronaviruses, as well as 24 other viral, fungal, and bacterial pathogens, at high titers. Clinical nasopharyngeal swab specimen testing (n = 140) showed 100%, 98.7%, and 99.3% positive, negative, and overall agreement, respectively, with a validated reverse transcription-PCR nucleic acid amplification test (NAAT) for SARS-CoV-2 RNA. These results provide validation evidence for a sensitive and specific method for pandemic-scale automated molecular diagnostic testing for SARS-CoV-2. |*Molecular Diagnostic Techniques[MESH] |*Nucleic Acid Amplification Techniques[MESH] |Automation, Laboratory[MESH] |Betacoronavirus/genetics/*isolation & purification[MESH] |COVID-19 Testing[MESH] |Clinical Laboratory Techniques[MESH] |Coronavirus Infections/diagnosis[MESH] |Humans[MESH] |Nasopharynx/virology[MESH] |RNA, Viral/genetics[MESH] |Reproducibility of Results[MESH] |SARS-CoV-2[MESH] |Sensitivity and Specificity[MESH]Performance Characteristics of a High-Throughput Automated Transcripti(epmc).pdf DeepDyve Pubget Overpricing