ADO 9.09% 2.4¢ anteotech ltd

Ann: AnteoTech COVID-19 Antigen Rapid Test Clinical Study Result, page-87

  1. 67 Posts.
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    CE mark is not a milestone by any means. It is very easy to obtain a CE mark. The result on the EU database returns 237 rapid antigen tests with CE marking. Dotz's does not seem to appear on the list yet.
    https://covid-19-diagnostics.jrc.ec.europa.eu/devices?manufacturer=&text_name=&marking=Yes&method=&rapid_diag=1&target_type=6&search_method=AND#form_content

    Dotz does not seem to provide detailed data on the sensitivity vs specificity. It says the following:
    "100% True Positive Rate for for viral loads of 1250 copies per mL in saliva. The limit of detection for the saliva-based Dotz Test Kit is 1,250 copies per mL when using 1mL of input sample."
    You can see in their announcement table that the true positive rate goes down to 70% at 313 copies per mL. Also we do not have data on who they have engaged to carry out the study and where they have notified for CE marking. It can really vary.

    To give you an idea of what the results means:
    "For example, an assay with LoD of 1,000 copies/mL, such as that of the CDC assay (8) or Genmark ePlex EUA (9), is expected to detect 77%, or 3 in 4, of infected individuals, for a false-negative rate of 22%."
    https://www.biorxiv.org/content/10.1101/2020.06.02.131144v1.full.pdf

    So no, this product will not last long given the competition. The buy volume for them was insignificant today. Probably those that do not understand the market and bought on the news.

    If you want to check which products are legitimate, the FDA list is still the best and most reliable. It is because the EU is too fragmented and there are too many notifying bodies that allows the companies to obtain CE mark. Also look at my previous posts regarding the market in the EU, I haven't posted that many.



 
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