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10.1007/s00705-021-05148-1

http://scihub22266oqcxt.onion/10.1007/s00705-021-05148-1
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suck abstract from ncbi


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pmid34259914      Arch+Virol 2021 ; 166 (9): 2551-2561
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  • Clinical evaluation of a multiplex real-time RT-PCR assay for detection of SARS-CoV-2 in individual and pooled upper respiratory tract samples #MMPMID34259914
  • Laverack M; Tallmadge RL; Venugopalan R; Cronk B; Zhang X; Rauh R; Saunders A; Nelson WM; Plocharczyk E; Diel DG
  • Arch Virol 2021[Sep]; 166 (9): 2551-2561 PMID34259914show ga
  • The aim of this study was to identify and validate a sensitive, high-throughput, and cost-effective SARS-CoV-2 real-time RT-PCR assay to be used as a surveillance and diagnostic tool for SARS-CoV-2 in a university surveillance program. We conducted a side-by-side clinical evaluation of a newly developed SARS-CoV-2 multiplex assay (EZ-SARS-CoV-2 Real-Time RT-PCR) with the commercial TaqPath COVID-19 Combo Kit, which has an Emergency Use Authorization from the FDA. The EZ-SARS-CoV-2 RT-PCR incorporates two assays targeting the SARS-CoV-2 N gene, an internal control targeting the human RNase P gene, and a PCR inhibition control in a single reaction. Nasopharyngeal (NP) and anterior nares (AN) swabs were tested as individuals and pools with both assays and in the ABI 7500 Fast and the QuantStudio 5 detection platforms. The analytical sensitivity of the EZ-SARS-CoV-2 RT-PCR assay was 250 copies/ml or approximately 1.75 genome copy equivalents per reaction. The clinical performance of the EZ-SARS-CoV-2 assay was evaluated using NP and AN samples tested in other laboratories. The diagnostic sensitivity of the assay ranged between 94 and 96% across the detection platforms, and the diagnostic specificity was 94.06%. The positive predictive value was 94%, and the negative predictive value ranged from 94 to 96%. Pooling five NP or AN specimens yielded 93% diagnostic sensitivity. The overall agreement between these SARS-CoV-2 RT-PCR assays was high, supported by a Cohen's kappa value of 0.93. The EZ-SARS-CoV-2 RT-PCR assay performance attributes of high sensitivity and specificity with AN sample matrix and pooled upper respiratory samples support its use in a high-throughput surveillance testing program.
  • |COVID-19 Nucleic Acid Testing/economics/instrumentation/*methods[MESH]
  • |COVID-19/*diagnosis/epidemiology/virology[MESH]
  • |Coronavirus Nucleocapsid Proteins/*genetics[MESH]
  • |Epidemiological Monitoring[MESH]
  • |Gene Expression[MESH]
  • |Humans[MESH]
  • |Multiplex Polymerase Chain Reaction/economics/instrumentation/*methods[MESH]
  • |Nasal Cavity/virology[MESH]
  • |Nasopharynx/virology[MESH]
  • |Phosphoproteins/genetics[MESH]
  • |RNA, Viral/*genetics[MESH]
  • |Reproducibility of Results[MESH]
  • |SARS-CoV-2/*genetics[MESH]
  • |Sensitivity and Specificity[MESH]
  • |Specimen Handling/methods[MESH]


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