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10.1016/j.ijid.2020.12.088

http://scihub22266oqcxt.onion/10.1016/j.ijid.2020.12.088
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suck abstract from ncbi


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pmid33434671      Int+J+Infect+Dis 2021 ; 104 (ä): 303-305
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  • Low clinical performance of the Isopollo COVID-19 detection kit (M Monitor, South Korea) for RT-LAMP SARS-CoV-2 diagnosis: A call for action against low quality products for developing countries #MMPMID33434671
  • Freire-Paspuel B; Garcia-Bereguiain MA
  • Int J Infect Dis 2021[Mar]; 104 (ä): 303-305 PMID33434671show ga
  • BACKGROUND: Multiple molecular kits are available for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) worldwide, with many lacking proper clinical evaluation due to the emergency caused by the coronavirus disease 2019 (COVID-19) pandemic, particularly in developing countries. METHODS: This study was conducted to evaluate the clinical performance of the Isopollo COVID-19 detection kit (M Monitor, South Korea) for reverse transcription loop-mediated isothermal amplification (RT-LAMP) SARS-CoV-2 diagnosis, using the SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) protocol as the gold standard. RESULTS: A total of 220 clinical samples were included in the study; 168 samples were SARS-CoV-2-positive and 52 samples were SARS-CoV-2-negative according to the SARS-CoV-2 RT-PCR protocol. For the Isopollo COVID-19 detection kit, only 104 out of 168 samples were SARS-CoV-2-positive. This result shows a low clinical performance, with sensitivity of 61.9% for the evaluated RT-LAMP assay. CONCLUSIONS: Proper clinical performance evaluation studies by regulatory agencies in developing countries such as Ecuador should be mandatory prior to clinical use authorization of SARS-CoV-2 diagnosis kits, particularly when those kits lack either US Food and Drug Administration or country of origin clinical use authorization.
  • |*Pandemics[MESH]
  • |COVID-19 Testing[MESH]
  • |COVID-19/*diagnosis/epidemiology/virology[MESH]
  • |Developing Countries[MESH]
  • |Ecuador/epidemiology[MESH]
  • |Humans[MESH]
  • |Molecular Diagnostic Techniques[MESH]
  • |Nucleic Acid Amplification Techniques[MESH]
  • |Reagent Kits, Diagnostic/*standards[MESH]
  • |Reverse Transcription[MESH]


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