2023-03-06: This example has been updated in IG4.0 by Jordan. SuppIS has been converted to NSIS per SDS request. Also, verified with Diane W, the use of "Multiple" rule here is not appropriate here, concatenated values are fine in ISBTAR.
Below is the updated version of the IS Example 11.
Row 1:
Shows the detection of immunoglobulin E (IgE) antibody against multiple animal allergens.
Rows 2-3:
Show the amount of IgE antibody against dog dander and its RAST classification score.
Rows 4-5:
Show the amount of IgE antibody against cat dander and its RAST classification score.
Rows 6-7:
Show the amount of IgE antibody against horse dander and its RAST classification score.
Rows 8-9:
Show the amount of IgE antibody against cow dander and its RAST classification score.
Row 10:
Shows immunoglobulin E (IgE) antibody against multiple tree pollen allergens is not detected.
is.xpt
is.xpt
Row
STUDYID
DOMAIN
USUBJID
ISSEQ
ISGRPID
ISREFID
ISTESTCD
ISTEST
ISBDAGNT
ISTSTDTL
ISORRES
ISORRESU
ISSTRESC
ISSTRESN
ISSTRESU
ISSPEC
ISMETHOD
VISITNUM
VISIT
ISDTC
1
XYZ
IS
XYZ1234
1
1
12453333
ARIGEAB
Allergen-induced IgE Antibody
ANIMAL MIX ANTIGENS
POSITIVE
POSITIVE
SERUM
RIA
1
SCREENING
2018-06-20
2
XYZ
IS
XYZ1234
2
2
12456666
ARIGEAB
Allergen-induced IgE Antibody
DOG DANDER ANTIGEN
0.12
U/mL
0.12
0.12
U/mL
SERUM
RIA
1
SCREENING
2018-06-20
3
XYZ
IS
XYZ1234
3
2
12456666
ARIGEAB
Allergen-induced IgE Antibody
DOG DANDER ANTIGEN
RAST SCORE
0
0
0
SERUM
RIA
1
SCREENING
2018-06-20
4
XYZ
IS
XYZ1234
4
3
12456666
ARIGEAB
Allergen-induced IgE Antibody
CAT DANDER ANTIGEN
0.19
U/mL
0.19
0.19
U/mL
SERUM
RIA
1
SCREENING
2018-06-20
5
XYZ
IS
XYZ1234
5
3
12456666
ARIGEAB
Allergen-induced IgE Antibody
CAT DANDER ANTIGEN
RAST SCORE
0
0
0
SERUM
RIA
1
SCREENING
2018-06-20
6
XYZ
IS
XYZ1234
6
4
12456666
ARIGEAB
Allergen-induced IgE Antibody
COW DANDER ANTIGEN
44
U/mL
44
44
U/mL
SERUM
RIA
1
SCREENING
2018-06-20
7
XYZ
IS
XYZ1234
7
4
12456666
ARIGEAB
Allergen-induced IgE Antibody
COW DANDER ANTIGEN
RAST SCORE
4
4
4
SERUM
RIA
1
SCREENING
2018-06-20
8
XYZ
IS
XYZ1234
8
5
12456666
ARIGEAB
Allergen-induced IgE Antibody
HORSE DANDER ANTIGEN
120
U/mL
120
120
U/mL
SERUM
RIA
1
SCREENING
2018-06-20
9
XYZ
IS
XYZ1234
9
5
12456666
ARIGEAB
Allergen-induced IgE Antibody
HORSE DANDER ANTIGEN
RAST SCORE
6
6
6
SERUM
RIA
1
SCREENING
2018-06-20
10
XYZ
IS
XYZ1234
10
12458888
ARIGEAB
Allergen-induced IgE Antibody
TREE MIX POLLENS
NEGATIVE
NEGATIVE
SERUM
RIA
1
SCREENING
2018-06-20
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The NSIS dataset below shows the specific and individual animal and tree pollen allergens within the mixed antigens panel tests. Users may wonder why the SDTM "MULTIPLE" convention is not used in the records below, this is because the tests are not "check/select some or all that apply" scenario. The allergen panel tests look for antibodies that target multiple allergens in the below dataset all at the same time and in a single analysis, and the outcome of the assessment is a pooled positive or negative result (IS dataset above rows 1 and 10). Therefore, all the targeted allergens are mapped to ISABTR and are separated with a semicolon.
BOX ELDER POLLEN; OLIVE TREE POLLEN; SILVER BIRCH POLLEN
$warningHtml
NSIS Variable Metadata [ISABTR]
Variable
Label
Type
Codelist
Role
ISABTR
Antibody Target
Char
Non-Standard Qualifier
Alternatively, instead of reporting the specific components of a mixed allergen panel, regional allergen mixes may also be reported by the specific regions/areas where they are predominant, as shown in the NSIS dataset below.