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10.1128/JCM.01072-20 http://scihub22266oqcxt.onion/10.1128/JCM.01072-20 32461285!7383558!32461285     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=32461285&cmd=llinks): Failed to open stream: HTTP request failed! 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Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens |pdf=|usr=}}{{32461285}} gab.com Text Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens JO: J Clin Microbiol http://www.kidney.de/pget.php?&tw=1&pmid=32461285 #FOAvip Several point-of-care (POC) molecular tests have received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The test performance characteristics of the Accula (Mesa Biotech) SARS-CoV-2 POC test need to be evaluated to inform its optimal use. The aim of this study was to assess the test performance of the Accula SARS-CoV-2 test. The performance of the Accula test was assessed by comparing results of 100 nasopharyngeal swab samples previously characterized by the Stanford Health Care EUA laboratory-developed test (SHC-LDT), targeting the envelope (E) gene. Assay concordance was assessed by overall percent agreement, positive percent agreement (PPA), negative percent agreement (NPA), and Cohen's kappa coefficient. Overall percent agreement between the assays was 84.0% (95% confidence interval [CI], 75.3 to 90.6%), PPA was 68.0% (95% CI, 53.3 to 80.5%), and the kappa coefficient was 0.68 (95% CI, 0.54 to 0.82). Sixteen specimens detected by the SHC-LDT were not detected by the Accula test and showed low viral load burden, with a median cycle threshold value of 37.7. NPA was 100% (95% CI, 94.2 to 100%). Compared to the SHC-LDT, the Accula SARS-CoV-2 test showed excellent negative agreement. However, positive agreement was low for samples with low viral load. The false-negative rate of the Accula POC test calls for a more thorough evaluation of POC test performance characteristics in clinical settings and for confirmatory testing in individuals with moderate to high pretest probability of SARS-CoV-2 who test negative on Accula. Twit Text FOAVip Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens ????J Clin Microbiol http://www.kidney.de/pget.php?&tw=1&pmid=32461285 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=32461285 #FOAvip English Wikipedia <ref>{{Cite pmid|32461285}}</ref> Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens #MMPMID32461285 Hogan CA; Garamani N; Lee AS; Tung JK; Sahoo MK; Huang C; Stevens B; Zehnder J; Pinsky BA J Clin Microbiol 2020[Jul]; 58 (8): ä PMID32461285show ga Several point-of-care (POC) molecular tests have received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The test performance characteristics of the Accula (Mesa Biotech) SARS-CoV-2 POC test need to be evaluated to inform its optimal use. The aim of this study was to assess the test performance of the Accula SARS-CoV-2 test. The performance of the Accula test was assessed by comparing results of 100 nasopharyngeal swab samples previously characterized by the Stanford Health Care EUA laboratory-developed test (SHC-LDT), targeting the envelope (E) gene. Assay concordance was assessed by overall percent agreement, positive percent agreement (PPA), negative percent agreement (NPA), and Cohen's kappa coefficient. Overall percent agreement between the assays was 84.0% (95% confidence interval [CI], 75.3 to 90.6%), PPA was 68.0% (95% CI, 53.3 to 80.5%), and the kappa coefficient was 0.68 (95% CI, 0.54 to 0.82). Sixteen specimens detected by the SHC-LDT were not detected by the Accula test and showed low viral load burden, with a median cycle threshold value of 37.7. NPA was 100% (95% CI, 94.2 to 100%). Compared to the SHC-LDT, the Accula SARS-CoV-2 test showed excellent negative agreement. However, positive agreement was low for samples with low viral load. The false-negative rate of the Accula POC test calls for a more thorough evaluation of POC test performance characteristics in clinical settings and for confirmatory testing in individuals with moderate to high pretest probability of SARS-CoV-2 who test negative on Accula. |*Point-of-Care Testing[MESH] |Adolescent[MESH] |Adult[MESH] |Aged[MESH] |Aged, 80 and over[MESH] |Betacoronavirus/genetics/*isolation & purification[MESH] |COVID-19[MESH] |COVID-19 Testing[MESH] |Child[MESH] |Child, Preschool[MESH] |Clinical Laboratory Techniques/*methods[MESH] |Coronavirus Infections/*diagnosis/virology[MESH] |False Negative Reactions[MESH] |Female[MESH] |Humans[MESH] |Infant[MESH] |Infant, Newborn[MESH] |Male[MESH] |Middle Aged[MESH] |Molecular Diagnostic Techniques/*methods[MESH] |Nasopharynx/virology[MESH] |Pandemics[MESH] |Pneumonia, Viral/*diagnosis/virology[MESH] |RNA, Viral/genetics[MESH] |SARS-CoV-2[MESH] |Sensitivity and Specificity[MESH]Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed A(epmc).pdf DeepDyve Pubget Overpricing