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10.1016/j.jcv.2020.104688

http://scihub22266oqcxt.onion/10.1016/j.jcv.2020.104688
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suck abstract from ncbi


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pmid33220549      J+Clin+Virol 2020 ; 133 (ä): 104688
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  • Validation of a modified CDC assay and performance comparison with the NeuMoDx and DiaSorin(R) automated assays for rapid detection of SARS-CoV-2 in respiratory specimens #MMPMID33220549
  • Lima A; Healer V; Vendrone E; Silbert S
  • J Clin Virol 2020[Dec]; 133 (ä): 104688 PMID33220549show ga
  • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), has spread rapidly around the globe since it was first identified in December of 2019 in Wuhan, China. In a race to contain the infection, researchers and healthcare officials have developed several assays to help diagnose individuals with COVID-19. To help laboratories decide what assay to bring into testing lines, factors such as assay availability, cost, throughput, and TAT should be considered. Here we validated a modified version of the CDC assay and used it as a reference to evaluate the performance of the NeuMoDxTM SARS-CoV-2 and DiaSorin SimplexaTM Covid-19 Direct assays. In silico analysis and clinical sample testing showed that the primers/probes designed by the CDC were specific to the SARS-CoV-2 as they accurately detected all reactive samples with an assay LoD of 200 copies/mL. The performance of the three assays were analyzed using 159 nasopharyngeal swabs specimen tested within 1-5 days after routine testing. A 100 % agreement was observed between the commercial assays and the modified CDC SARS-CoV-2 assay. A deeper look at the Ct values showed no significant difference between NeuMoDx and the modified CDC SARS-CoV-2 assay, whereas DiaSorin had lower overall Ct values than the modified CDC SARS-CoV-2 assay. NeuMoDx and DiaSorin workflows were much easier to perform. NeuMoDx has the highest throughput and shortest TAT, whereas although the modified CDC SARS-CoV-2 assay has comparable throughput to DiaSorin, it has the longest hands-on time and highest TAT.
  • |Automation, Laboratory[MESH]
  • |COVID-19 Nucleic Acid Testing/*methods[MESH]
  • |COVID-19/*diagnosis[MESH]
  • |Centers for Disease Control and Prevention, U.S.[MESH]
  • |Humans[MESH]
  • |Limit of Detection[MESH]
  • |Nasopharynx/*virology[MESH]
  • |Reagent Kits, Diagnostic[MESH]
  • |SARS-CoV-2/genetics[MESH]
  • |Sensitivity and Specificity[MESH]


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