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The IFNG Response test toward M. Tuberculosis is modeled in the LB domain, in the TB-TAUG as the following:

ELISA:

ELISPOT:

There are several issues with this modeling:

  1. Where do you show that this challenge assay is done against the TB antigens?
  2. CP domain has developed a new standard variable called Test Condition Agent/CNDAGT, which is used to represent stimulating agents, like the values in ASSYAG above, should this variable be added to LB? CP Specification
  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.
    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 level it goes to LB vs. IFNg response test toward a specific, known bug then it goes to IS?
    3. If this test remains in LB, should NHOID be added to LB in order to show the name of the bug? I remember this being discussed by Jon/Bess when they worked on the TB TAUG.


If we were to model this in IS:

is.xpt

xx.xpt

Row

STUDYID

DOMAIN

USUBJID

ISSEQ

ISGRPID

NHOID

ISTESTCD

ISTEST

ISCNDAGT

ISTSTDTL

ISORRES

ISORRESU

ISSTRESC

ISSTRESN

ISSTRESU

ISSPEC

ISMETHOD

VISITNUMVISIT

ISDTC

1

ABC

IS

ABC-01-201

1

1

Mycobacterium tuberculosis

IFNG

Interferon Gamma

Nil

1.3

IU/mL

1.3

1.3

IU/mL

PLASMA

ELISA




2

ABC

IS

ABC1230-011

2

1

Mycobacterium tuberculosisIFNG

Interferon Gamma

ESAT-6, CFP-10, TB 7.7


6.2

IU/mL

6.2

6.2

IU/mL

PLASMA

ELISA




3ABCIS

ABC1230-011

3

1

Mycobacterium tuberculosisIFNG

Interferon Gamma

Mitogen


0.9

IU/mL

0.9

0.9

IU/mL

PLASMA

ELISA




4ABCIS

ABC1230-011

4

1

Mycobacterium tuberculosisIFNG

Interferon Gamma


Interpretation

Positive


Positive



PLASMA

ELISA




$warningHtml

Similarly if we were to model Jozef's request in IS for https://loinc.org/95971-8/ --- SARS CoV-2 stimulated gamma interferon [Presence] in Blood

is.xpt

xx.xpt

Row

STUDYID

DOMAIN

USUBJID

ISSEQ

ISGRPID

NHOID

ISTESTCD

ISTEST

ISCNDAGT

ISTSTDTL

ISORRES

ISORRESU

ISSTRESC

ISSTRESN

ISSTRESU

ISSPEC

ISMETHOD

VISITNUMVISIT

ISDTC

1

ABC

IS

ABC-01-201

1

1

SARS-CoV-2

IFNG

Interferon Gamma

Nil

1.3

IU/mL

1.3

1.3

IU/mL

PLASMA

ELISA




2

ABC

IS

ABC1230-011

2

1

SARS-CoV-2IFNG

Interferon Gamma

SARS-CoV-2 Antigen


6.2

IU/mL

6.2

6.2

IU/mL

PLASMA

ELISA




3ABCIS

ABC1230-011

3

1

SARS-CoV-2IFNG

Interferon Gamma

Mitogen


0.9

IU/mL

0.9

0.9

IU/mL

PLASMA

ELISA




4ABCIS

ABC1230-011

4

1

SARS-CoV-2IFNG

Interferon Gamma


Interpretation

Present


Present



PLASMA

ELISA




$warningHtml

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