Is it appropriate to use NHOID in this example where you are testing anti-RSV IgG antibody in the patient? In this assessment, the microbe is not the subject of the observation, this is measuring the host/subject immune response.
In reference to the published examples where NHOID is used, observations are made and tests are run on the microbe itself - the results tell you something about and relevant to the microbe:
is it susceptible to an antibiotics? (MS)
does it have some mutations or sequence changes in its genome? (GF)
can the subject antibody stop it from infecting cells? (IS)
for all of the above, you are running tests that have a direct impact on the microbe, or the observations/assessments tell you something about the microbe, but not necessarily about the host/subject.
In the below example, this is a use-case where the subject's humoral immune responses are measured by the quantification of anti-RSV IgG antibody toward vaccine-delivered RSV antigens (proteins B and Z), the observations (results) are about the study subject's protective antiviral antibody levels which indicates how he responds to the vaccine stimulation. It doesn't tell you anything about the bugs. Normally and traditionally, the model would look like example 1. However, in reality, what needs to be collected and modeled is Example 2.
Having NHOID in example 2 helps to identify the specific strains from which the vaccine is derived, but this is beyond the scope of how NHOID is defined and used.
Question: Can we expand the scope of NHOID in this case? Why was the variable scope limited to "observations about the non-host microbe" in the first place, what were/are the concerns?
Example 1: 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 the strain Human respiratory syncytial virus MinA
HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z is from the strain 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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Example 2: With NHOID, but this is stretching the scope of this variable.