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10.1016/j.jviromet.2021.114067

http://scihub22266oqcxt.onion/10.1016/j.jviromet.2021.114067
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33476707!7813505!33476707
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suck abstract from ncbi


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pmid33476707      J+Virol+Methods 2021 ; 290 (ä): 114067
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  • Analytical performances of five SARS-CoV-2 whole-blood finger-stick IgG-IgM combined antibody rapid tests #MMPMID33476707
  • Pere H; Mboumba Bouassa RS; Tonen-Wolyec S; Podglajen I; Veyer D; Belec L
  • J Virol Methods 2021[Apr]; 290 (ä): 114067 PMID33476707show ga
  • Facing the ongoing pandemic caused by SARS-CoV-2, there is an urgent need for serological assays identifying individuals previously infected by coronavirus disease 2019 (COVID-19), including rapid diagnostic tests (RDTs). We herein compared five new CE-IVD-labeled commercially available SARS-CoV-2 whole-blood finger-stick IgG/IgM combined RDTs, in parallel according to the manufacturers' instructions, with two serum panels obtained from 48 patients with confirmed COVID-19 (panel I) and from a group of 52 patients randomly selected, for whom serum samples collected before the COVID-19 epidemic (from October 1 to November 30, 2019) were negative for SARS-CoV-2 IgG (panel II). We found a sensitivity of 95.8 %, 91.6 %, 92.3 %, 97.9 % and 91.4 %, and a specificity of 98.1 %, 86.5 %, 100 %, 98.1 % and 84.6 %, for BIOSYNEX COVID-19 BSS (IgG/IgM) (Biosynex Swiss SA, Freiburg, Switzerland), Humasis COVID-19 IgG/IgM Test (Humasis Co., Ltd., Gyneonggi, Republic of Korea), LYHER COVID-19 IgM/IgG Rapid Test (Medakit Ltd, Hong Kong, China), SIENNA COVID-19 (IgG/IgM) Rapid Test Cassette (Salofa Oy, Salo, Finland) and NG-BIOTECH COVID-19 (IgG/IgM) (NG-Biotech, Guipry, France), respectively. Commercially available SARS-CoV-2 IgG/IgM combined RDTs have a sufficient sensitivity for identifying individuals with past SARS-CoV-2 infection, but some RDTs may lack of specificity, with risk of false positivity mainly for the IgM band.
  • |*COVID-19 Serological Testing[MESH]
  • |Antibodies, Viral/blood[MESH]
  • |COVID-19/*diagnosis[MESH]
  • |False Positive Reactions[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Immunoassay[MESH]
  • |Immunoglobulin G/*blood[MESH]
  • |Immunoglobulin M/*blood[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |SARS-CoV-2/immunology/*isolation & purification[MESH]
  • |Sensitivity and Specificity[MESH]


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