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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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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With NHOID, but this is stretching the scope of this variable.
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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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