Adapters Request Portal

New driver to support new US sample type - cobas 5800

The cobas HPV Test for the cobas 5800/6800/8800 Systems is being updated to include a new US-specific sample type: ''Self, vaginal''

  • Guest
  • May 5 2023
  • Released
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  • Guest commented
    June 03, 2024 11:37

    Seems that this ticket is still open?
    PLease assign & fix in next release.
    HIM has been updated and is approved

    http://diadoc.roche.com/_layouts/15/Roche.DiaDoc/Portal/Download.aspx?DocId=0000000000001200000555299|000|09|004&filetype=PrintPDF&current=0

  • Paola Maita Gonzalez commented
    May 09, 2023 10:35

    Hello Clarence,

    Thanks for the clarification. Now I understand better the context. Yes please, provide a draft of this document if you have it.

    Regards,

    Paola

  • Guest commented
    May 08, 2023 23:43

    Hi Paola,


    That sample type was added last year to support self collected specimen testing for cobas HPV in CE.


    This year we will be adding self collected specimen testing to cobas HPV for US. Unfortunately, in the US market, RCCM is not support and cannot be listed for regulatory reasons. Thus, we have to create a new sample type for the US with the codes defined above.


    The Host Interface manual has not been updated yet to include this information. But I can provide a draft if necessary.


    Best,

    Clarence

  • Paola Maita Gonzalez commented
    May 08, 2023 15:32

    Hello Clarance,

    Thanks for reaching out.

    I see in the cobas5800 v3.2.0 -latest version released-, this specimen type supported: SVAG^self, vaginal - RCCM/PC^99ROC.

    Is this the one you need us to support?

    On the other hand, the manual you provided is supported already in the driver, as X800 Data Manager · Host Interface Manual · For IHE Laboratory Analytical Workflow (LAW) profile · Version 2.0 · Software version 1.5

    Thanks,

    Paola