A performance evaluation report from Etilab SA, Switzerland
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Chromatographic Immunoassy) Product No. MF-68
Antigen Rapid Test (Colloidal Gold) using a lateral flow immunofluorescent sandwich assay to detects the novel coronavirus in human nasopharyngeal(NP) or nasal swabs sample. COVID-19 antigen can detect the presence of viral protein. It can identify acute or early infection. Suitable for large-scale screening of the general population and epidemiological investigations in low-endemic areas.
Fluorecare COVID_19 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay) has passed the validation criteria, as described in the Ordonnance 3 COVID-19 (2020-3758), published on the official page of Federal Office of Public Health (FOPH).
To conclude,the overall results indicate very good sensibility (92.2%) and specificity (100%) of the Fluorecare COVID-19 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay).