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Mikrochim Acta . Rapid detection of SARS-CoV-2 antigen based on IgG colloidal gold immunochromatographic strip

tetano

Editor, Senior Moderator
Mikrochim Acta


. 2025 Jun 12;192(7):420.
doi: 10.1007/s00604-025-07299-3. Rapid detection of SARS-CoV-2 antigen based on IgG colloidal gold immunochromatographic strip

Han Wu[SUP] #[/SUP][SUP] 1 [/SUP], Hai Li[SUP] #[/SUP][SUP] 1 [/SUP], Jiayi Shu[SUP] 1 [/SUP], Changyan Yang[SUP] 1 [/SUP], Jianglong Wang[SUP] 1 [/SUP], Haitao Li[SUP] 1 [/SUP], Min Shao[SUP] 2 [/SUP], Hefeng Zhou[SUP] 3 [/SUP]



Affiliations
Abstract

In December 2019, Wuhan, China, reported the first cases of pneumonia caused by a previously unknown coronavirus, subsequently designated SARS-CoV-2. This pathogen precipitated a global pandemic of coronavirus disease 2019 (COVID-19). The virus primarily transmits via aerosols, direct contact, and contaminated surfaces. Its high infectivity and rapid transmission have posed severe public health challenges on a global scale, emphasizing the essential need for precise and swift diagnostic techniques to effectively track and curb its transmission. To address this need, we designed a highly efficient approach, namely a colloidal gold immunochromatographic strip (CGICS) based on an IgG-mediated immunoassay, for the specific capture of the SARS-CoV-2 nucleocapsid (N) antigen. Evaluation of the assay's specificity with a panel of common respiratory viral pathogens revealed that the CGICS specifically recognized SARS-CoV-2, with no cross-reactivity observed against non-target viruses. In addition, limit-of-detection (LOD) assessments indicated that the minimum detectable concentration was 2 ng/mL, and agreement analysis experiments showed a concordance rate of 98%, demonstrating high specificity and sensitivity. The resulting CGICS was capable of detecting SARS-CoV-2 antigen within 5-15 min. This study provides a rapid diagnostic approach for early SARS-CoV-2 infection, offering significant implications for effective disease prevention, control, and clinical diagnosis.

Keywords: Colloidal gold; ELISA; Monoclonal antibodies; Nucleocapsid protein; SARS-COV-2.

 
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