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Is it appropriate to use NHOID in this example where you are testing anti-RSV epitope IgG antibody in the patient? The bug is the subject of the observation, this is measuring host/subject immune response.

This example is been tweaked to include NHOID, see the orginal IS example 5 in the SDTMIG 3.4: IS Example 5

In the published examples where NHOID is used, observations are made and tests are run on the bug - the result tells you something about the bug:

  • is it susceptible to an antibiotics (MS)
  • does it have some mutations in its genome (GF)
  • can the antibody stop it from infecting cells (IS)
  • all of the above, you are running tests that directly impact the microbe, and tells you something about the microbe.

In the below example, this is measuring the subject/host immune response toward a vaccine-delivered antigen, the observation is about the study subject, not about the bug. Having NHOID here is beyond the scope of how this variable is defined and used.

If you want to know which strain of the virus is used to make and generate the vaccine, is that actually device domain information?

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is.xpt

Row

STUDYID

DOMAIN

USUBJID

NHOID

ISSEQ

ISREFID

ISGRPID

ISTESTCD

ISTEST

ISBDAGNT

ISTSTOPO

ISCAT

ISSCAT

ISORRES

ISSTRESC

ISSTRESN

ISSTRESU

ISSPEC

ISMETHOD

VISITNUM

VISIT

ISDTC

1

RSV1230

IS

RSV1230-011

Human respiratory syncytial virus (strain RSB1734) 

1

13668

1

MBIGGAB

Microbial-induced IgG Antibody

HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B

SCREEN

STUDY VACCINE-RELATED IMMUNOGENICITYHUMORAL IMMUNITY

POSITIVE

POSITIVE



SERUM

ELISA

1

BASELINE

2017-05-27

2

RSV1230

IS

RSV1230-011

Human respiratory syncytial virus (strain RSB1734) 

2

13668

1MBIGGAB

Microbial-induced IgG Antibody

HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B

QUANTIFY

STUDY VACCINE-RELATED IMMUNOGENICITY

HUMORAL IMMUNITY

1:25

25

25titer

SERUM

ELISA

1

BASELINE

2017-05-27

3

RSV1230

IS

RSV1230-011

Human respiratory syncytial virus (strain RSB1734) 

1

13668

2

MBIGGAB

Microbial-induced IgG Antibody

HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z

SCREEN

NON-STUDY-RELATED IMMUNOGENICITYHUMORAL IMMUNITYPOSITIVEPOSITIVE

SERUM

ELISA

1

BASELINE

2017-05-27

4

RSV1230

IS

RSV1230-011

Human respiratory syncytial virus (strain RSB1734) 

2

13668

2

MBIGGAB

Microbial-induced IgG Antibody

HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z

QUANTIFY

NON-STUDY-RELATED IMMUNOGENICITYHUMORAL IMMUNITY1:120120120titer

SERUM

ELISA

1

BASELINE

2017-05-27

5

RSV1230

IS

RSV1230-011

Human respiratory syncytial virus (strain RSB1734) 

1

13669


MBIGGAB

Microbial-induced IgG Antibody

HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B

QUANTIFY

STUDY VACCINE-RELATED IMMUNOGENICITY

HUMORAL IMMUNITY

1:90

90

90

titer

SERUM

ELISA

2

VISIT 1

2017-07-27

6RSC1230IS

RSV1230-011

Human respiratory syncytial virus (strain RSB1734) 213670
MBIGGAB

Microbial-induced IgG Antibody

HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B

QUANTIFY

STUDY VACCINE-RELATED IMMUNOGENICITY

HUMORAL IMMUNITY1:220220220titer

SERUM

ELISA

3VISIT 22017-08-27
7RSC1230IS

RSV1230-011

Human respiratory syncytial virus (strain RSB1734) 313671
MBIGGAB

Microbial-induced IgG Antibody

HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B

QUANTIFY

STUDY VACCINE-RELATED IMMUNOGENICITY

HUMORAL IMMUNITY1:500500500titer

SERUM

ELISA

4VISIT 32017-09-27
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