Public Health Informatics

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Guidance forthcoming on submitting Monkeypox testing data

  • 1.  Guidance forthcoming on submitting Monkeypox testing data

    Posted 08-08-2022 02:05 PM

    Dear Informatics Leads:

    APHL has received multiple inquiries regarding the transfer of monkeypox data from public health laboratories (PHLs) to the Centers for Disease Control and Prevention (CDC). Currently, PHLs performing the CDC Laboratory Response Network for Biological Threats (LRN-B) U.S. Food and Drug Administration (FDA) 510(k) Non-variola Orthopoxvirus Real-time PCR assay should continue to submit all results through ELR, LRN Results Messenger or LIMSi.

    APHL is aware that multiple PHLs are actively working to validate a monkeypox specific laboratory developed test (LDT). There is currently no determined method to transfer data resulting from an LDT to CDC. Data resulting from an LDT should not be submitted to the LRN or through any other existing data pipeline at this time. APHL is working with our partners at CDC to determine a route to submit LDT data and will communicate instructions to PHLs once a plan is finalized.

    For more information, please contact Sam Abrams at samuel.abrams@aphl.org at 240-485-2731.



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    Samuel Abrams
    Senior Specialist, Informatics
    APHL
    Silver Spring MD
    (240) 485-2731
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