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10.1093/ajcp/aqaa181

http://scihub22266oqcxt.onion/10.1093/ajcp/aqaa181
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33015712!7665304!33015712
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suck abstract from ncbi


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pmid33015712      Am+J+Clin+Pathol 2021 ; 155 (1): 69-78
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  • A Comparison of Five SARS-CoV-2 Molecular Assays With Clinical Correlations #MMPMID33015712
  • Procop GW; Brock JE; Reineks EZ; Shrestha NK; Demkowicz R; Cook E; Ababneh E; Harrington SM
  • Am J Clin Pathol 2021[Jan]; 155 (1): 69-78 PMID33015712show ga
  • OBJECTIVES: Comparative assessments of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular assays that have been operationalized through the US Food and Drug Administration's Emergency Use Authorization process are warranted to assess real-world performance. Characteristics such as sensitivity, specificity, and false-negative rate are important to inform clinical use. METHODS: We compared five SARS-CoV-2 assays using nasopharyngeal and nasal swab specimens submitted in transport media; we enriched this cohort for positive specimens, since we were particularly interested in the sensitivity and false-negative rate. Performance of each test was compared with a composite standard. RESULTS: The sensitivities and false-negative rates of the 239 specimens that met inclusion criteria were, respectively, as follows: Centers for Disease Control and Prevention 2019 nCoV Real-Time RT-PCR Diagnostic Panel, 100% and 0%; TIB MOLBIOL/Roche z 480 Assay, 96.5% and 3.5%; Xpert Xpress SARS-CoV-2 (Cepheid), 97.6% and 2.4%; Simplexa COVID-19 Direct Kit (DiaSorin), 88.1% and 11.9%; and ID Now COVID-19 (Abbott), 83.3% and 16.7%. CONCLUSIONS: The assays that included a nucleic acid extraction followed by reverse transcription polymerase chain reaction were more sensitive than assays that lacked a full extraction. Most false negatives were seen in patients with low viral loads, as extrapolated from crossing threshold values.
  • |Adult[MESH]
  • |Aged[MESH]
  • |COVID-19 Nucleic Acid Testing/*methods/standards[MESH]
  • |COVID-19/*diagnosis[MESH]
  • |Cohort Studies[MESH]
  • |False Negative Reactions[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Logistic Models[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]


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