Evaluation of a Lateral Flow Immunoassay COVIDTECH ® SARS-CoV-2 IgM/IgG Antibody Rapid Test

Japanese journal of infectious diseases

article

Julien Exinger¹  Cédric Hartard²  Fanny Lafferrière¹  Christelle Fenninger¹  Loic J. Charbonnière⁴  Hélène Jeulin² 

[1] Laboratory of Medical Biology, Haguenau Hospital Center;LCPME, Lorraine University;Virology Laboratory;Synthesis for analysis team, IPHC, UMR 7178 CNRS/Strasbourg University

关键词: SARS-CoV-2;    COVID-19;    serology;    immunoassay;   

DOI  :  10.7883/yoken.JJID.2021.273

学科分类：传染病学

来源: National Institute of Infectious Diseases

【 摘 要 】

The new coronavirus severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is responsible for severe respiratory illness (i.e., COVID-19). RT-PCR of respiratory samples is the gold standard for COVID-19 diagnosis, and serological tests may contribute to the detection of post-infection and post-vaccination immunity and enable seroprevalence studies. The lateral flow immunoassay (LFIA) COVIDTECH® SARS-CoV-2 IgM/IgG antibody rapid test that detects anti-SARS-CoV-2 IgM and IgG using an S protein recombinant antigen has been independently evaluated in two laboratories. The specificity evaluated for 65 pre-pandemic samples was 100% for IgM/IgG. An analysis of samples from patients with RT-PCR-confirmed infection revealed that IgM/IgG antibodies were detected in 18/26 (69%) samples before day 13 and in 58/58 (100%) samples from day 14 post-symptom onset. Before day 14 post-symptom onset, the COVIDTECH Test was less sensitive than other LFIA method (BIOSYNEX COVID-19 BSS IgM/IgG) and a chemiluminescent immunoassay (LIAISON® 14 days since the onset of symptoms.

【 授权许可】

Unknown