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  1. Where do you show that this challenge assay is done against M. Tuberculosis (or any microbe of interest, like SARS-CoV-2), where do you map M. Tb? - NHOID is NOT appropriate and should NOT be used here because in this case, the subject of study is NOT the Mycobacterium tuberculosis itself but whether someone has been previously exposed to M. Tuberculosis, by examining whether there is heightened Interferon-gamma activation. A positive result does not mean the person is currently infected with Mycobacterium tuberculosis, it may mean that the person had been previously infected by, or vaccinated against M. Tuberculosis. NHOID is used when you know the microorganism or a reference strain is present in the testing sample.  M. Tuberculosis is mapped to ISCNDAGT to indicate that the stimulating agents are TB antigens.

    1. Info
      titleWhen should NHOID be used?

      NHOID, defined by the Non-host Organism Identifiers (OI) domain, should be used to map microorganisms that have been either experimentally determined in the course of a study or are previously known (e.g., lab strains used as reference in the study). In other words, NHOID is used when the study subject is the microorganism, and when the microorganism is present in the testing sample. In vaccine efficacy studies, a subject’s post-immunization sera is often incubated with a microbial strain of interest, where the functional capacities of the vaccine-induced antibodies are measured through whether the antibodies can effectively stop (from infection), neutralize, and kill the study microorganism of interest, in vitro. Examples of such tests include microneutralization, hemagglutination inhibition, and opsonophagocytic-killing assays. These are tests which measure the direct effect of the antimicrobial antibodies on the microorganism; therefore, said microorganism is the study subject and should be mapped to NHOID.

      Tests that measure and quantify a subject's cellular and humoral immune responses to a microorganism or a vaccination agent—such as measurements of activated cytokine- or antibody–secreting cells, or cytokine response assays (e.g., interferon gamma response test)—are biological measurements about the human subject. Because these are not assessments about the microorganism itself, NHOID should not be used.


  2. CP domain has developed a new standard variable called Test Condition Agent/CNDAGT (CP Specification), which is used to represent stimulating agents, like the values in ASSYAG above, should this variable be added to LB, or IS? 
    Status
    colourGreen
    titleTeam agrees

  3. Lastly, Interferon-Gamma Response Assay is a classic immunological test, is it correct to map this to the LB domain?
    1. Can we model this in the IS domain, see example dataset below. Yes -
      Status
      colourGreen
      titleTeam Agrees
    2. If we model this test in IS, how do we distinguish it from the INFg test in lab. Can we draw the line where if we are running a routine lab test looking for IFNg levels it goes to LB vs. IFNg challenge/response test toward a specific, known microorganism then it goes to IS? Yes-
      Status
      colourGreen
      titleTeam Agrees

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Dataset wrap


Dataset2
hi1styleyellow
hi1column ISBDAGNT
tableidIS table 1


Row

STUDYID

DOMAIN

USUBJID

ISSEQ

ISGRPID

ISTESTCD

ISTEST

ISCNDAGT

ISTSTDTL

ISORRES

ISORRESU

ISSTRESC

ISSTRESN

ISSTRESU

ISSPEC

ISMETHOD

VISITNUMVISIT

ISDTC

1

ABC

IS

ABC1230-011

1

1

IFNG

Interferon Gamma

Nil

1.3

IU/mL

1.3

1.3

IU/mL

BLOOD

ELISA




2

ABC

IS

ABC1230-011

2

1

IFNG

Interferon Gamma

SARS-CoV-2 Antigen

or

(SARS-CoV-2 Spike Protein, etc.)


6.2

IU/mL

6.2

6.2

IU/mL

BLOOD

ELISA




3ABCIS

ABC1230-011

3

1

IFNG

Interferon Gamma

Mitogen


0.9

IU/mL

0.9

0.9

IU/mL

BLOOD

ELISA




4ABCIS

ABC1230-011

4

1

IFNG

Interferon Gamma


Interpretation

Positive


Positive



BLOOD

ELISA






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