Date
Attendees
- Bess LeRoy
- Jordan Li
- philip pochon
- Nik Pemble
- Erin Muhlbradt
- Fred Wood
- Craig M. Zwickl
- anna.pron-zwick@astrazeneca.com
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
Time | Item | Who | Notes |
---|---|---|---|
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 links: Malaria 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. |