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Updated: Aug 24, 2025
A Rapid, Multiplex Dual Reporter IgG and IgM SARS-CoV-2 Neutralization Assay for a Multiplexed Bead-Based Flow Analysis System
Published on: April 6, 2021
Analytical sensitivity of six lateral flow antigen test kits for variant strains of SARS-CoV-2
Yoshitomo Morinaga1, Hiroshi Yamada2, Yoshihiro Yoshida2
1Department of Microbiology, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan; Clinical and Research Center for Infectious Diseases, Toyama University Hospital, Toyama, Japan.
Introduction:
The lateral flow antigen test is a useful tool for rapid diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The analytical sensitivity of six lateral flow antigen test kits was compared.
Methods:
The limit of detection (LoD) and time to positive results were evaluated for six lateral flow tests including ImmunoArrow®, ESPLINE® SARS-CoV-2, QuickNavi™ COVID19 Ag, ImmunoAce® SARS-CoV-2, Panbio™ COVID-19 Ag Rapid Test Device, and SARS-CoV-2 Rapid Antigen Test using the heat-inactivated virus. The LoD of ImmunoArrow® against the Omicron variants was compared with that against the wild-type using recombinant proteins.
Results:
ImmunoArrow® and ESPLINE® showed the lowest LoD. The time to positive results of all tests except for ESPLINE® was within 200 s in the evaluation at high dose of antigens (2.5 × 105 TCID50/mL) and 500 s in the evaluation at low dose of antigens (2.5 × 104 TCID50/mL). The LoD of ImmunoArrow® against the Omicron variants was the same concentration against the wild-type antigen.
Conclusions:
ImmunoArrow® detected SARS-CoV-2 antigens including the Omicron variants with good sensitivity among the six lateral flow antigen tests. These finding support that it can support the rapid diagnosis of COVID-19 with the good sensitivity.
