tetano
Editor, Senior Moderator
J Virol Methods
. 2021 Jan 18;114067.
doi: 10.1016/j.jviromet.2021.114067. Online ahead of print.
Analytical performances of five SARS-CoV-2 whole-blood finger-stick IgG-IgM combined antibody rapid tests
H?l?ne P?r?[SUP] 1 [/SUP], Ralph-Sydney Mboumba Bouassa[SUP] 2 [/SUP], Serge Tonen-Wolyec[SUP] 3 [/SUP], Isabelle Podglajen[SUP] 4 [/SUP], David Veyer[SUP] 5 [/SUP], Laurent B?lec[SUP] 6 [/SUP]
Affiliations
Abstract
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.
Keywords: Blood specimen; COVID-19; False positivity; IgG; IgM; Immunochromatography; Rapid diagnostic test; SARS-CoV-2; Sensitivity; Specificity.
. 2021 Jan 18;114067.
doi: 10.1016/j.jviromet.2021.114067. Online ahead of print.
Analytical performances of five SARS-CoV-2 whole-blood finger-stick IgG-IgM combined antibody rapid tests
H?l?ne P?r?[SUP] 1 [/SUP], Ralph-Sydney Mboumba Bouassa[SUP] 2 [/SUP], Serge Tonen-Wolyec[SUP] 3 [/SUP], Isabelle Podglajen[SUP] 4 [/SUP], David Veyer[SUP] 5 [/SUP], Laurent B?lec[SUP] 6 [/SUP]
Affiliations
- PMID: 33476707
- DOI: 10.1016/j.jviromet.2021.114067
Abstract
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.
Keywords: Blood specimen; COVID-19; False positivity; IgG; IgM; Immunochromatography; Rapid diagnostic test; SARS-CoV-2; Sensitivity; Specificity.