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Not letting me quote/reply to Surges directly, but why did the...

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    Not letting me quote/reply to Surges directly, but why did the UK data not lead to CE mark granting?

    Presumably because the UK testing revealed large variability in the viral load depending on how the oral saliva sample was collected. As Derek says in the video, they have an obligation as a legal manufacturer of medical test to provide an instruction for use that gives consistent results. My guess is that the CE mark cannot be granted for the saliva use case until a consistent and reproducible collection method is determined. As he states - the repetitional damage in getting this wrong would be extreme. They know that when the antigen is present in saliva, they can detect it perfectly. It seems the hurdle to overcome here is clinical trials to determine the method of collection which ensures the sample is valid to test in the first place.

    The three separate trials in India I am guessing are what is referred to in the SE Asian distribution announcement:
    "In collaboration with a potential distribution partner in India, AnteoTech commenced a prospective clinical evaluation in June to evaluate the efficacy of different sample specimens as an alternative to the current nasopharyngeal protocol. This includes efficacy testing of saliva samples from the oralmucosa, oropharyngeal throat samples and mid-turbinate nasal samples for the detection of SARSCoV-2 antigen".

    Sounds to me like three separate trials testing 3 separate collection methods - oral mucosa sampling (cheek swab), oropharyngeal throat samples (tonsillar bed and back of throat swab), and mid-turbinate nasal sampling (shallow swab 2cm into nostrils).
 
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