Is it appropriate to use NHOID in this example where you are testing anti-RSV IgG antibody in the patient? The bug is not the subject of the observation, this is measuring host/subject immune response.
In the published examples where NHOID is used, observations are made and tests are run on the bug itself - the result tells you something about the bug:
is it susceptible to an antibiotics? (MS)
does it have some mutations in its genome or sequence changes? (GF)
can the antibody stop it from infecting cells? (IS)
For all of the above, you are running tests that directly impact the microbe, and the observations/assessments tell you something about the microbe, but not necessarily the host/subject.
In the below example, this is measuring the subject/host immune response (in antibody quantification/titer) toward a vaccine-delivered viral antigen, the observation is about the study subject and how he responds to the vaccine stimulation. It technically has nothing to do with the bug, it doesn't tell me anything about the bug. Having NHOID in this example is beyond the scope of how this variable is defined and used.
Question: Can we expand the scope of NHOID in this case? Why was the variable scope so limited in the first place, where were/are the concerns?
Without NHOID. Where do you map the info that the antibody targets (HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B, HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z) are actually from two different strains of RSV virus?
HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B is from Human respiratory syncytial virus MinA
HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z is from Human respiratory syncytial virus (strain RSP112/Sweden/02-03)
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is.xpt
Row
STUDYID
DOMAIN
USUBJID
ISSEQ
ISGRPID
ISTESTCD
ISTEST
ISBDAGNT
ISTSTOPO
ISCAT
ISSCAT
ISORRES
ISSTRESC
ISSTRESN
ISSTRESU
ISSPEC
ISMETHOD
VISITNUM
VISIT
ISDTC
1
RSV1230
IS
RSV1230-011
1
1
MBIGGAB
Microbial-induced IgG Antibody
HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B
SCREEN
STUDY VACCINE-RELATED IMMUNOGENICITY
HUMORAL IMMUNITY
POSITIVE
POSITIVE
SERUM
ELISA
1
BASELINE
2017-05-27
2
RSV1230
IS
RSV1230-011
2
1
MBIGGAB
Microbial-induced IgG Antibody
HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B
QUANTIFY
STUDY VACCINE-RELATED IMMUNOGENICITY
HUMORAL IMMUNITY
1:25
25
25
titer
SERUM
ELISA
1
BASELINE
2017-05-27
3
RSV1230
IS
RSV1230-011
1
2
MBIGGAB
Microbial-induced IgG Antibody
HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z
SCREEN
STUDY VACCINE-RELATED IMMUNOGENICITY
HUMORAL IMMUNITY
POSITIVE
POSITIVE
SERUM
ELISA
1
BASELINE
2017-05-27
4
RSV1230
IS
RSV1230-011
2
2
MBIGGAB
Microbial-induced IgG Antibody
HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z
QUANTIFY
STUDY VACCINE-RELATED IMMUNOGENICITY
HUMORAL IMMUNITY
1:120
120
120
titer
SERUM
ELISA
1
BASELINE
2017-05-27
5
RSV1230
IS
RSV1230-011
1
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
6
RSC1230
IS
RSV1230-011
2
MBIGGAB
Microbial-induced IgG Antibody
HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B
QUANTIFY
STUDY VACCINE-RELATED IMMUNOGENICITY
HUMORAL IMMUNITY
1:220
220
220
titer
SERUM
ELISA
3
VISIT 2
2017-08-27
7
RSV1230
IS
RSV1230-011
1
MBIGGAB
Microbial-induced IgG Antibody
HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z
QUANTIFY
STUDY VACCINE-RELATED IMMUNOGENICITY
HUMORAL IMMUNITY
1:140
140
140
titer
SERUM
ELISA
2
VISIT 1
2017-07-27
8
RSC1230
IS
RSV1230-011
2
MBIGGAB
Microbial-induced IgG Antibody
HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z
QUANTIFY
STUDY VACCINE-RELATED IMMUNOGENICITY
HUMORAL IMMUNITY
1:400
400
400
titer
SERUM
ELISA
3
VISIT 2
2017-08-27
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With NHOID, but this is stretching the scope of this variable.