First, we present here the results of a method validation study and not a seroprevalence study. The COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to COVID-19 in human whole blood, serum or plasma specimen. Diagnostic accuracy of Augurix COVID‐19 IgG test. Vassarstats online tool was also used to determine sensitivity (SN), specificity (SP), and positive and negative predictive values (PPV and NPV). To validate the diagnostic accuracy of the Augurix SARS‐CoV‐2 IgM/IgG rapid immunoassay diagnostic test (RDT) for COVID‐19. Serology‐based assays have not only been shown to be clinically relevant to COVID‐19 diagnosis in specific cases, but can also indicate the true nature and extent of the population's exposure to SARS‐CoV‐2. Results from IgG/IgM tests three weeks after symptoms started suggested that if 1000 people had antibody tests, and 50 (5%) of them really had COVID-19 (as we might expect in a national screening survey): - 58 people would test positive for COVID-19. IgG RDT performances were similar between plasma and whole blood. Finally, our present conclusions only apply to the Augurix RDT and must not be applied to any other RDTs currently available. All patients within the DPD >14 days subgroup were seropositive by rIFA. The Covid-19 IgM/IgG Rapid Test is a point-of-care leteral flow immunoassays for the diagnosis of the coronavirus infection. Both methods revealed similar results in 86 of 91 samples 94.5% (95%CI: 88%‐98%), and their concordance was evaluated at 0.86 (Kendall τ correlation coefficient, P < .0001). In general, antibodies can be detected 1-3 weeks after infection. When considering samples taken >14 days after RT‐PCR diagnosis, NPV was 100% (95%CI:90‐100), and PPV was 100% (95%CI:72‐100). Now worldwide our product is being used to screen patients for the corona virus. Only laboratory‐based information was used in this study. With an accuracy of 99%, the COVID-19-IgM / IgG-POC Rapid Test Kit tests blood for Coronavirus 2 (SARS-CoV-2) with severe acute respiratory syndrome. In addition, four and seven patients displaying COVID‐19 symptoms who obtained false negative results with RT‐PCR were confirmed to have COVID‐19 based on their antibody response using CLIA. Some manufacturers make their own claims for accuracy. Preprint DOI : http://dx.doi.org/10.2139/ssrn.3582814, © 2019 – 2020 NG BIOTECH Tous droits réservés. Augurix RDTs were provided by Mr P. Ducret (GaDia, Switzerland). European Journal of Clinical Investigation, European Journal of Clinical Investigation, https://www.who.int/publications‐detail/immunity‐passports‐in‐the‐context‐of‐covid‐19, All cases (n = 91), IgG rIFA seropositivity 35%, DPD 0‐6 and controls (N = 65), IgG rIFA seropositivity 15%, DPD 7‐14 and controls (N = 59), IgG rIFA seropositivity 18%, DPD > 14 and controls (N = 57), IgG rIFA seropositivity 23%. Number of times cited according to CrossRef: Rapid Antibody-Based COVID-19 Mass Surveillance: Relevance, Challenges, and Prospects in a Pandemic and Post-Pandemic World. Every pack contains 30 Biozek Rapid Test COVID-19 Kits, NCP=402, 2019-nCoV How it works ? WB‐EDTA samples were used as a proxy of capillary blood and were centrifuged (3000 g 10 minutes) in parallel to generate EDTA plasma. 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