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10.1016/j.jcv.2020.104374

http://scihub22266oqcxt.onion/10.1016/j.jcv.2020.104374
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32361322!7195305!32361322
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suck abstract from ncbi


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pmid32361322      J+Clin+Virol 2020 ; 127 (ä): 104374
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  • Interpret with caution: An evaluation of the commercial AusDiagnostics versus in-house developed assays for the detection of SARS-CoV-2 virus #MMPMID32361322
  • Rahman H; Carter I; Basile K; Donovan L; Kumar S; Tran T; Ko D; Alderson S; Sivaruban T; Eden JS; Rockett R; O'Sullivan MV; Sintchenko V; Chen SC; Maddocks S; Dwyer DE; Kok J
  • J Clin Virol 2020[Jun]; 127 (ä): 104374 PMID32361322show ga
  • INTRODUCTION: There is limited data on the analytical performance of commercial nucleic acid tests (NATs) for laboratory confirmation of COVID-19 infection. METHODS: Nasopharyngeal, combined nose and throat swabs, nasopharyngeal aspirates and sputum was collected from persons with suspected SARS-CoV-2 infection, serial dilutions of SARS-CoV-2 viral cultures and synthetic positive controls (gBlocks, Integrated DNA Technologies) were tested using i) AusDiagnostics assay (AusDiagnostics Pty Ltd); ii) in-house developed assays targeting the E and RdRp genes; iii) multiplex PCR assay targeting endemic respiratory viruses. Discrepant SARS-CoV-2 results were resolved by testing the N, ORF1b, ORF1ab and M genes. RESULTS: Of 52 clinical samples collected from 50 persons tested, respiratory viruses were detected in 22 samples (42 %), including SARS CoV-2 (n?=?5), rhinovirus (n?=?7), enterovirus (n?=?5), influenza B (n?=?4), hMPV (n?=?5), influenza A (n?=?2), PIV-2 (n?=?1), RSV (n?=?2), CoV-NL63 (n?=?1) and CoV-229E (n?=?1). SARS-CoV-2 was detected in four additional samples by the AusDiagnostics assay. Using the in-house assays as the "gold standard", the sensitivity, specificity, positive and negative predictive values of the AusDiagnostics assay was 100 %, 92.16 %, 55.56 % and 100 % respectively. The Ct values of the real-time in-house-developed PCR assay targeting the E gene was significantly lower than the corresponding RdRp gene assay when applied to clinical samples, viral culture and positive controls (mean 21.75 vs 28.1, p?=?0.0031). CONCLUSIONS: The AusDiagnostics assay is not specific for the detection SARS-CoV-2. Any positive results should be confirmed using another NAT or sequencing. The case definition used to investigate persons with suspected COVID-19 infection is not specific.
  • |Adolescent[MESH]
  • |Adult[MESH]
  • |Aged[MESH]
  • |Aged, 80 and over[MESH]
  • |Betacoronavirus/*isolation & purification[MESH]
  • |COVID-19[MESH]
  • |Child[MESH]
  • |Child, Preschool[MESH]
  • |Coronavirus Infections/*diagnosis[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Infant[MESH]
  • |Infant, Newborn[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Molecular Diagnostic Techniques/*methods[MESH]
  • |Nasopharynx/*virology[MESH]
  • |Pandemics[MESH]
  • |Pneumonia, Viral/*diagnosis[MESH]
  • |SARS-CoV-2[MESH]
  • |Sensitivity and Specificity[MESH]


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