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10.1016/j.jviromet.2021.114182

http://scihub22266oqcxt.onion/10.1016/j.jviromet.2021.114182
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33984397!8108471!33984397
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suck abstract from ncbi


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pmid33984397      J+Virol+Methods 2021 ; 294 (ä): 114182
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  • Evaluation of the analytical performance and specificity of a SARS-CoV-2 transcription-mediated amplification assay #MMPMID33984397
  • Schneider M; Iftner T; Ganzenmueller T
  • J Virol Methods 2021[Aug]; 294 (ä): 114182 PMID33984397show ga
  • The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic requires fast and accurate high-throughput diagnostic tools. To evaluate the analytical performance of the Hologic Aptima transcription-mediated amplification (TMA) assay for detection of SARS-CoV-2 RNA from respiratory samples we analysed 103 clinical and proficiency panel samples pre-tested by real-time RT-PCR (Altona, RealStar) and found a positive percent agreement (sensitivity) of 95.7 % and a negative percent agreement (specificity) of 100 %. The limit of detection of the Aptima test was 150 copies/mL determined as 95 % detection probability. To further assess the Aptima assay's specificity we prospectively analysed 7545 clinical specimens from the upper and lower respiratory tract sent for the purpose of routine SARS-CoV-2 screening. SARS-CoV-2 RNA was detected in 16/7545 (0.2 %) samples by the TMA assay and confirmed independently by the Xpert SARS-CoV-2 RT-PCR (Cepheid); in one case a previous discrepant result was confirmed as true SARS-CoV-2 infection in a subsequent sample from the same patient. Results from the Aptima SARS-CoV-2 TMA assay agreed well with RT-PCR and showed an excellent specificity in a large number of routine specimens despite the low prevalence at that time of the pandemic, indicating that this assay can be used even for screening purposes.
  • |Asymptomatic Infections[MESH]
  • |COVID-19 Testing/methods/*standards[MESH]
  • |Clinical Laboratory Techniques/methods/standards[MESH]
  • |Humans[MESH]
  • |Limit of Detection[MESH]
  • |Nasopharynx/virology[MESH]
  • |Nucleic Acid Amplification Techniques/methods/*standards[MESH]
  • |Prospective Studies[MESH]
  • |RNA, Viral/*genetics[MESH]
  • |Reagent Kits, Diagnostic/*standards[MESH]
  • |Retrospective Studies[MESH]
  • |SARS-CoV-2/*genetics[MESH]


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