Analytical sensitivity of six lateral flow antigen test kits for variant strains of SARS-CoV-2. Issue 2 (February 2023)

• Record Type: Journal Article
• Authors: Morinaga, Yoshitomo; Yamada, Hiroshi; Yoshida, Yoshihiro; Kawasuji, Hitoshi; Yamamoto, Yoshihiro
• Is Part Of: Journal of infection and chemotherapy. Volume 29:Issue 2(2023)
• Page Start: 131
• Page End: 135
• Publication Date: 2023-02
• Subjects: Omicron -- Antigen tests -- Lateral flow tests -- Immunochromatography -- Point-of-care testing; Chemotherapy -- Periodicals; Infection -- Periodicals; Communicable diseases -- Chemotherapy -- Periodicals; 615.5805
• DOI: 10.1016/j.jiac.2022.10.004
• Languages: English
• ISSNs: 1341-321X

Abstract

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 s in the evaluation at high dose of antigens (2.5 × 10 5 TCID50 /mL) and 500 s in the evaluation at low dose of antigens (2.5 × 10 4 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.