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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)? - use NHOID? NHOID is not appropriate here because in this case the subject of study is not the TB bug itself but whether someone has been previously exposed with TB. A positive result does not mean the person is currently infected with TB, it may mean the person had been previously infected or vaccinated with TB. NHOID is used when you know the bug or reference strain is presented in the testing sample. 
  2. StatuscolourGreentitleTeam agreesCP 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


NHOIDMycobacterium tuberculosis

Row

STUDYID

DOMAIN

USUBJID

ISSEQ

ISGRPID

ISTESTCD

ISTEST

ISCNDAGT

ISTSTDTL

ISORRES

ISORRESU

ISSTRESC

ISSTRESN

ISSTRESU

ISSPEC

ISMETHOD

VISITNUMVISIT

ISDTC

1

ABC

IS

ABC-01-201

1

1

IFNG

Interferon Gamma

Nil

1.3

IU/mL

1.3

1.3

IU/mL

BLOOD

ELISA




2

ABC

IS

ABC-01-201

Mycobacterium tuberculosis

2

1

IFNG

Interferon Gamma

Mycobacterium tuberculosis ESAT-6, CFP-10, TB 7.7


6.2

IU/mL

6.2

6.2

IU/mL

BLOOD

ELISA




3ABCIS

ABC-01-201

Mycobacterium tuberculosis

3

1

IFNG

Interferon Gamma

Mitogen


0.9

IU/mL

0.9

0.9

IU/mL

BLOOD

ELISA




4ABCIS

ABC-01-201

Mycobacterium tuberculosis

4

1

IFNG

Interferon Gamma


Interpretation

Positive


Positive



BLOOD

ELISA






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