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J Infect Chemother . Analytical sensitivity of six lateral flow antigen test kits for variant strains of SARS-CoV-2

tetano

Editor, Senior Moderator
J Infect Chemother


. 2022 Oct 17;S1341-321X(22)00287-2.
doi: 10.1016/j.jiac.2022.10.004. Online ahead of print.
Analytical sensitivity of six lateral flow antigen test kits for variant strains of SARS-CoV-2


Yoshitomo Morinaga[SUP] 1 [/SUP], Hiroshi Yamada[SUP] 2 [/SUP], Yoshihiro Yoshida[SUP] 2 [/SUP], Hitoshi Kawasuji[SUP] 3 [/SUP], Yoshihiro Yamamoto[SUP] 4 [/SUP]



Affiliations

Abstract

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 sec in the evaluation at high dose of antigens (2.5 × 10[SUP]5[/SUP] TCID[SUB]50[/SUB]/mL) and 500 sec in the evaluation at low dose of antigens (2.5 × 10[SUP]4[/SUP] TCID[SUB]50[/SUB]/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.

Keywords: Antigen tests; Immunochromatography; Lateral flow tests; Omicron; Point-of-care testing.
 
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