New kit serum antigen test COVIBLOOD

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  • #448522
    Sylvie CORMONT
    Participant

    Have you heard of a new serum antigen test for the SARS CORONAVIRUS 2 ?

    Is a code being created?

    #448524
    Pam Banning
    Moderator

    Hello Sylvie,

    Regenstrief Institute and the LOINC team are working closely with the US Food & Drug Administration and the Center for Disease Control on identifying the appropriate LOINC term to use for each SARS-CoV-2 assay that has received FDA’s Emergency Use Authorization (EUA). These can be tracked on the CDC’s website at https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html. I checked the latest edition (November 18, 2020), and COVIBLOOD or COVI-LAB is not listed as yet. Nor is it listed on the FDA’s EUA page : https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidinvitrodev

    It is possible you’ve inquired just as the processes are unfolding. Do you have additional information on the manufacturer’s name? Please post any additional information that you’re aware of. The LOINC team accelerates COVID-19 term development.

    Thank you,

    Pam Banning, Lab LOINC committee co-chair

    #448525
    Pam Banning
    Moderator

    The following was received from Sylvie as an email. Keeping here for continuity. Will keep an eye out for it.

    Hello,

    Unfortunately, I have no information on the manufacturer.

    I was hoping you could provide me with it.

    It is certainly under development.

    Than you

    Sylvie Cormont, PA

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