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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
is.xpt
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is.xpt
Row
STUDYID
DOMAIN
USUBJID
NHOID ISSEQ
ISREFID
ISGRPID
ISTESTCD
ISTEST
ISBDAGNT
ISTSTOPO
ISCAT
ISSCAT
ISORRES
ISSTRESC
ISSTRESN
ISSTRESU
ISSPEC
ISMETHOD
VISITNUM
VISIT
ISDTC
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
SERUM
ELISA 1
BASELINE
2017-05-27
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
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 SERUM
ELISA 1
BASELINE
2017-05-27
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
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
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 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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