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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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | ISSEQ | ISGRPID | ISTESTCD | ISTEST | ISBDAGNT | ISTSTOPO | ISCAT | ISSCAT | ISORRES | ISSTRESC | ISSTRESN | ISSTRESU | ISSPEC | ISMETHOD | VISITNUM | VISIT | ISDTC |
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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 |
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| SERUM | ELISA | 1 | BASELINE | 2017-05-27 |
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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 |
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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 |
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| SERUM | ELISA | 1 | BASELINE | 2017-05-27 |
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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 |
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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 |
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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 |
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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 |
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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.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | NHOID | ISSEQ | ISGRPID | ISTESTCD | ISTEST | ISBDAGNT | ISTSTOPO | ISCAT | ISSCAT | ISORRES | ISSTRESC | ISSTRESN | ISSTRESU | ISSPEC | ISMETHOD | VISITNUM | VISIT | ISDTC |
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1 | RSV1230 | IS | RSV1230-011 | Human respiratory syncytial virus MinA | 1 | 1 | MBIGGAB | Microbial-induced IgG Antibody | HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B | SCREEN | STUDY VACCINE-RELATED IMMUNOGENICITY | HUMORAL IMMUNITY | POSITIVE | POSITIVE |
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| SERUM | ELISA | 1 | BASELINE | 2017-05-27 |
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2 | RSV1230 | IS | RSV1230-011 | Human respiratory syncytial virus MinA | 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 |
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3 | RSV1230 | IS | RSV1230-011 | Human respiratory syncytial virus (strain RSP112/Sweden/02-03) | 1 | 2 | MBIGGAB | Microbial-induced IgG Antibody | HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z | SCREEN | STUDY VACCINE-RELATED IMMUNOGENICITY | HUMORAL IMMUNITY | POSITIVE | POSITIVE |
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| SERUM | ELISA | 1 | BASELINE | 2017-05-27 |
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4 | RSV1230 | IS | RSV1230-011 | Human respiratory syncytial virus (strain RSP112/Sweden/02-03) | 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 |
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5 | RSV1230 | IS | RSV1230-011 | Human respiratory syncytial virus MinA | 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 |
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6 | RSC1230 | IS | RSV1230-011 | Human respiratory syncytial virus MinA | 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 |
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7 | RSV1230 | IS | RSV1230-011 | Human respiratory syncytial virus (strain RSP112/Sweden/02-03) | 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 |
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8 | RSC1230 | IS | RSV1230-011 | Human respiratory syncytial virus (strain RSP112/Sweden/02-03) | 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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