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10.1093/jalm/jfaa135

http://scihub22266oqcxt.onion/10.1093/jalm/jfaa135
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32761092!7454585!32761092
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suck abstract from ncbi


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pmid32761092      J+Appl+Lab+Med 2020 ; 5 (6): 1307-1312
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  • Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA #MMPMID32761092
  • Stevens B; Hogan CA; Sahoo MK; Huang C; Garamani N; Zehnder J; Kurzer J; Pinsky BA
  • J Appl Lab Med 2020[Nov]; 5 (6): 1307-1312 PMID32761092show ga
  • BACKGROUND: Numerous nucleic acid amplification assays utilizing different target genes of the SARS-CoV-2 genome have received emergency use authorization (EUA) by the United States Food and Drug Administration (FDA). Limited data are available comparing the test performance characteristics of these assays. METHODS: A diagnostic comparison study was performed to evaluate the performance of the Cepheid Xpert Xpress SARS-CoV-2 assay compared to the Hologic Panther Fusion SARS-CoV-2 assay using clinical nasopharyngeal specimens. Agreement between the two assays was assessed by overall, positive, and negative percent agreement and Cohen's kappa coefficient. RESULTS: A total of 104 (54 positive and 50 negative) clinical nasopharyngeal samples were tested by both assays. Using the Panther Fusion as a reference standard, the Xpert demonstrated an overall agreement of 99.0% [95% confidence interval (CI): 94.8-100], positive percent agreement of 98.1% (95% CI: 90.1-100), and a negative percent agreement of 100% (95% CI: 94.2-100). The kappa coefficient was 0.98 (95% CI: 0.94-1.0). One sample positive by the Panther Fusion with a cycle threshold (Ct) of 38.6 was found to be reproducibly negative by the Xpert assay. CONCLUSIONS: The Cepheid Xpert Xpress SARS-CoV-2 assay provides test performance comparable to the Hologic Panther Fusion SARS-CoV-2 assay while offering laboratories rapid, on-demand testing capacity.
  • |Automation, Laboratory/instrumentation[MESH]
  • |Betacoronavirus/genetics/*isolation & purification[MESH]
  • |COVID-19[MESH]
  • |COVID-19 Testing[MESH]
  • |Clinical Laboratory Techniques/*instrumentation/statistics & numerical data[MESH]
  • |Coronavirus Infections/*diagnosis/epidemiology/virology[MESH]
  • |Humans[MESH]
  • |Molecular Diagnostic Techniques/*instrumentation/statistics & numerical data[MESH]
  • |Multiplex Polymerase Chain Reaction/instrumentation[MESH]
  • |Pandemics[MESH]
  • |Pneumonia, Viral/*diagnosis/epidemiology/virology[MESH]
  • |Point-of-Care Systems/statistics & numerical data[MESH]
  • |RNA, Viral/*isolation & purification[MESH]
  • |Reagent Kits, Diagnostic/statistics & numerical data[MESH]
  • |Real-Time Polymerase Chain Reaction/instrumentation[MESH]
  • |Reproducibility of Results[MESH]
  • |SARS-CoV-2[MESH]
  • |Time Factors[MESH]


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