Analytical performances of five SARS-CoV-2 whole-blood finger-stick IgG-IgM combined antibody rapid tests.

Analytical performances of five SARS-CoV-2 whole-blood finger-stick IgG-IgM combined antibody rapid tests.
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DOI:
10.1016/j.jviromet.2021.114067
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发表时间:
2021-04
影响因子:
3.1
通讯作者:
Bélec L
Bélec L
中科院分区:
医学4区
文献类型:
--
作者:
Péré H;Mboumba Bouassa RS;Tonen-Wolyec S;Podglajen I;Veyer D;Bélec L

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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.
DOI: 10.1038/s41591-020-0913-5
发表时间: 2020-07
期刊: Nature medicine
影响因子: 82.9
作者:
Amanat F;Stadlbauer D;Strohmeier S;Nguyen THO;Chromikova V;McMahon M;Jiang K;Arunkumar GA;Jurczyszak D;Polanco J;Bermudez-Gonzalez M;Kleiner G;Aydillo T;Miorin L;Fierer DS;Lugo LA;Kojic EM;Stoever J;Liu STH;Cunningham-Rundles C;Felgner PL;Moran T;García-Sastre A;Caplivski D;Cheng AC;Kedzierska K;Vapalahti O;Hepojoki JM;Simon V;Krammer F
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发表时间: 2020-08-01
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