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10.1186/s12985-020-01445-4

http://scihub22266oqcxt.onion/10.1186/s12985-020-01445-4
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33189137!7666399!33189137
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suck abstract from ncbi


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pmid33189137      Virol+J 2020 ; 17 (1): 178
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  • Poor sensitivity of "AccuPower SARS-CoV-2 real time RT-PCR kit (Bioneer, South Korea)" #MMPMID33189137
  • Freire-Paspuel B; Garcia-Bereguiain MA
  • Virol J 2020[Nov]; 17 (1): 178 PMID33189137show ga
  • BACKGROUND: Several molecular kits are available for SARS-CoV-2 diagnosis, mostly lacking of proper clinical evaluation due to the emergency caused by COVID19 pandemia, particularly at developing countries like Ecuador. OBJECTIVE: We carried out an evaluation of the clinical performance of "AccuPower SARS-CoV-2 Real Time RT-PCR kit" (Bioneer, South Korea) for SARS-CoV-2 diagnosis using 2019-nCoV CDC EUA kit (IDT, USA) as a gold standard. RESULTS: 48 clinical specimens were included on the study, 38 tested SARS-CoV-2 positive and 10 SARS-CoV-2 negative for 2019-nCoV CDC EUA kit. For "AccuPower SARS-CoV-2 Real Time RT-PCR kit", only 30 were SARS-CoV-2 positive, indicating a low clinical performance with sensitivity of 78.9%. Moreover, the limit of detection for "AccuPower SARS-CoV-2 Real Time RT-PCR kit" was estimated to be higher than 40,000 viral RNA copies/mL of sample. CONCLUSIONS: Proper clinical performance evaluation studies from government agencies at developing countries should be mandatory prior to clinical use authorization of SARS-CoV-2 diagnosis kits, particularly when those kits lack of either FDA or its country of origin clinical use authorization, to prevent the distribution of low quality products that may have a negative impact of COVID19 surveillance at developing countries.
  • |*COVID-19 Nucleic Acid Testing/standards[MESH]
  • |COVID-19/*diagnosis[MESH]
  • |Ecuador/epidemiology[MESH]
  • |Humans[MESH]
  • |Limit of Detection[MESH]
  • |Molecular Diagnostic Techniques[MESH]
  • |Reagent Kits, Diagnostic[MESH]
  • |SARS-CoV-2/genetics/*isolation & purification[MESH]


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