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10.1093/jalm/jfaa187

http://scihub22266oqcxt.onion/10.1093/jalm/jfaa187
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33674879!7665530!33674879
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suck abstract from ncbi


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pmid33674879      J+Appl+Lab+Med 2021 ; 6 (2): 421-428
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  • Analytic Sensitivity of 3 Nucleic Acid Detection Assays in Diagnosis of SARS-CoV-2 Infection #MMPMID33674879
  • Sieker JT; Horowitz C; Hu CK; Lacombe-Daphnis M; Chirokas B; Pina C; Heger NE; Rabson AR; Zhou M; Bogen SA; Horowitz GL
  • J Appl Lab Med 2021[Mar]; 6 (2): 421-428 PMID33674879show ga
  • BACKGROUND: Detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription PCR is the primary method to diagnose coronavirus disease 2019 (COVID-19). However, the analytic sensitivity required is not well defined and it is unclear how available assays compare. METHODS: For the Abbott RealTime SARS-CoV-2 assay (m2000; Abbott Molecular), we determined that it could detect viral concentrations as low as 26 copies/mL, we defined the relationship between cycle number and viral concentrations, and we tested naso- and oropharyngeal swab specimens from 8538 consecutive individuals. Using the m2000 as a reference assay method, we described the distribution of viral concentrations in these patients. We then used selected clinical specimens to determine the positive percent agreement of 2 other assays with more rapid turnaround times [Cepheid Xpert Xpress (GeneXpert; Cepheid); n = 27] and a laboratory developed test on the Luminex ARIES system [ARIES LDT (Luminex); n = 50] as a function of virus concentrations, from which we projected their false-negative rates in our patient population. RESULTS: SARS-CoV-2 was detected in 27% (95% CI: 26%-28%) of all specimens. Estimated viral concentrations were widely distributed, and 17% (95% CI: 16%-19%) of positive individuals had viral concentrations <845 copies/mL. Positive percent agreement was strongly related to viral concentration, and reliable detection (i.e., >/=95%) was observed at concentrations >100 copies/mL for the GeneXpert but not the ARIES LDT, corresponding to projected false-negative rates of 4% (95% CI: 0%-21%) and 27% (95% CI: 11%-46%), respectively. CONCLUSIONS: Substantial proportions of clinical specimens have low to moderate viral concentrations and may be missed by methods with less analytic sensitivity.
  • |*Reagent Kits, Diagnostic[MESH]
  • |Adult[MESH]
  • |Aged[MESH]
  • |Aged, 80 and over[MESH]
  • |COVID-19 Nucleic Acid Testing/*instrumentation[MESH]
  • |COVID-19/*diagnosis/virology[MESH]
  • |False Negative Reactions[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Limit of Detection[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |RNA, Viral/isolation & purification[MESH]
  • |Real-Time Polymerase Chain Reaction/*instrumentation[MESH]
  • |Reproducibility of Results[MESH]
  • |Retrospective Studies[MESH]


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