Date

Attendees

Goals

  • - Potentially you could have the same test in both MB and LB but this needs clarification so the users are not confused?
    - The MB domain should not contain the organism as the test?
    - What does the FDA want in the MB domain?

Discussion items

TimeItemWhoNotes
   

Do we support the antigen test in both LB and MB?  Yes.

Do we allow antigen and antibody test sharing in LB and MB?

     - LB is for human subject test

     - MB is for microorganism identification only

The screening antigen test is the issue. 

     - The intention of the study is important. 

          - If the intent is the clinical indication of the study then use MB. 

          - If the intent is just a screening test on an entirely different indication then use LB.

   

Should we have a separate MB domain? 

Should LB and MB go together?

   

Currently there are 7 terms in the existing published terminology in the Microbiology Test Code/Name codelists: 

Acid-Fast Bacilli

Influenza A Antigen

Influenza A/B Antigen

Influenza B Antigen

Mycobacterium Tuberculosis

Mycobacterium Tuberculosis Complex

Viral Identification

   

NEW requests for the Microbiology Test Code/Name codelists:

Malaria TAUG linksMalaria Smear 1; Malaria Smear 2; Malaria Smear 3; http://wiki.cdisc.org/x/37-dAQ; http://wiki.cdisc.org/x/csjdAQ;

Plasmodium

Plasmodium falciparum, Asexual

Plasmodium falciparum, Sexual

Plasmodium vivax, Asexual

Plasmodium vivax, Sexual

Plasmodium falciparum

pLHD Antigen

HRP2 Antigen

pLHD Antigen and HRP2 Antigen

Plasmodium vivax

Plasmodium ovale

Plasmodium ovale, Asexual

Plasmodium ovale, Sexual

Plasmodium malariae

Plasmodium malariae, Asexual

Plasmodium malariae, Sexual

Plasmodium knowlesi

Plasmodium knowlesi, Asexual

Plasmodium knowlesi, Sexual

Ebola TAUG links:  Diagnosis Ct; Diagnosis 2;

Zaire Ebolavirus 

Ebola Virus IgM Antibody

   Everyone should give this some more thought and please add comments/questions to this wiki page.  We can also schedule an additional meeting to continue this discussion.

Action items

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