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
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Row | STUDYID | DOMAIN | USUBJID | NHOID | ISSEQ | ISREFID | 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 (strain RSB1734) | 1 | 13668 | 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 (strain RSB1734) | 2 | 13668 | 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 RSB1734) | 1 | 13668 | 2 | MBIGGAB | Microbial-induced IgG Antibody | HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z | SCREEN | NON-STUDY-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 RSB1734) | 2 | 13668 | 2 | MBIGGAB | Microbial-induced IgG Antibody | HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z | QUANTIFY | NON-STUDY-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 (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 |
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6 | RSC1230 | IS | RSV1230-011 | Human respiratory syncytial virus (strain RSB1734) | 2 | 13670 |
| 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 | RSC1230 | IS | RSV1230-011 | Human respiratory syncytial virus (strain RSB1734) | 3 | 13671 |
| MBIGGAB | Microbial-induced IgG Antibody | HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B | QUANTIFY | STUDY VACCINE-RELATED IMMUNOGENICITY | HUMORAL IMMUNITY | 1:500 | 500 | 500 | titer | SERUM | ELISA | 4 | VISIT 3 | 2017-09-27 |
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