| Request | Notes | Status | Fixed/Updated/Removed from SDTMIG v4.0? |
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This is sponsor inquiry. How do you model pre-specified ANA tests? | Question about how to model ANA data that are collected, and therefore should be molded differently from the example that's shown in the SDTMIG 3.4. | | | Status |
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| colour | Green |
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| title | update complete |
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2023-03-24: Added to SDTMIG v4.0. |
User Inquiry:
"I wanted to revisit this discussion on ANA pattern reporting. We also deal with testing labs where they pre-coordinate the pattern result into the test name and perform a call of whether the pattern is observed or not. For example, the 'test' the lab performs evaluates each staining pattern as listed below:
...
- https://loinc.org/14722-3/ Presence
- https://loinc.org/29953-7/ Titer
https://loinc.org/14611-8/ Pattern
| Example |
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| Dataset wrap |
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| | Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | ISSEQ | ISREFID | ISGRPID | ISTESTCD | ISTEST | ISBDAGNT | ISTSTDTL | ISTSTOPO | ISORRES | ISORRESU | ISSTRESC | ISSTRESN | ISSTRESU | ISSPEC | ISMETHOD | VISITNUM | VISIT | ISDTC |
|---|
| 1 | XYZ | IS | XYZ1234 | 1 | 19283746 | 1 | ATAB | Autoantibody | NUCLEAR AUTOANTIGENS |
| SCREEN | POSITIVE |
| POSITIVE |
|
| SERUM | FLUORESCENT IMMUNOASSAY | 1 | SCREENING | 2018-06-20 |
|---|
| 2 | XYZ | IS | XYZ1234 | 2 | 19283746 | 1a | ATAB | Autoantibody | NUCLEAR AUTOANTIGENS |
| QUANTIFY | 1:340 |
| 340 | 340 | titer | SERUM | FLUORESCENT IMMUNOASSAY | 1 | SCREENING | 2018-06-20 |
|---|
| 3 | XYZ | IS | XYZ1234 | 3 | 19283746 | 1a | ATAB | Autoantibody | NUCLEAR AUTOANTIGENS | STAINING PATTERN |
| CYTOPLASMIC,
SPECKLED PATTERN |
| CYTOPLASMIC, SPECKLED PATTERN |
|
| SERUM | FLUORESCENT IMMUNOASSAY | 1 | SCREENING | 2018-06-20 |
|---|
| 4 | XYZ | IS | XYZ1234 | 4 | 19283746 | 1b | ATAB | Autoantibody | NUCLEAR AUTOANTIGENS |
| QUANTIFY | 1:170 |
| 170 | 170 | titer | SERUM | FLUORESCENT IMMUNOASSAY | 1 | SCREENING | 2018-06-20 |
|---|
| 5 | XYZ | IS | XYZ1234 | 5 | 19283746 | 1b | ATAB | Autoantibody | NUCLEAR AUTOANTIGENS | STAINING PATTERN |
| NUCLEAR, NUCLEOLAR PATTERN |
| NUCLEAR, NUCLEOLAR PATTERN |
|
| SERUM | FLUORESCENT IMMUNOASSAY | 1 | SCREENING | 2018-06-20 |
|---|
| 6 | XYZ | IS | XYZ1007 | 1 | 19283746 | 1 | ATAB | Autoantibody | NUCLEAR AUTOANTIGENS |
| SCREEN | NEGATIVE |
| NEGATIVE |
|
| SERUM | FLUORESCENT IMMUNOASSAY | 1 | SCREENING | 2018-06-20 |
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Pre-specified findings modeling: Do you observe nuclear centromere ANA pattern? Do you observe cytoplasmic speckled ANA pattern? etc.
...
https://loinc.org/96921-2/ Titer
| Example |
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|
| Dataset wrap |
|---|
| | Dataset2 |
|---|
Row | STUDYID | DOMAIN | USUBJID | ISSEQ | ISREFID | ISGRPID | ISTESTCD | ISTEST | ISBDAGNT | ISTSTDTL | ISTSTOPO | ISORRES | ISORRESU | ISSTRESC | ISSTRESN | ISSTRESU | ISSPEC | ISMETHOD | VISITNUM | VISIT | ISDTC |
|---|
| 1 | XYZ | IS | XYZ1234 | 1 | 19283746 | 1 | ATAB | Autoantibody | NUCLEAR AUTOANTIGENS | CYTOPLASMIC, SPECKLED PATTERN | SCREEN | POSITIVE |
| POSITIVE |
|
| SERUM | FLUORESCENT IMMUNOASSAY | 1 | SCREENING | 2018-06-20 |
|---|
| 2 | XYZ | IS | XYZ1234 | 2 | 19283746 | 1 | ATAB | Autoantibody | NUCLEAR AUTOANTIGENS | CYTOPLASMIC, SPECKLED PATTERN | QUANTIFY | 1:170 |
| 170 | 170 | titer | SERUM | FLUORESCENT IMMUNOASSAY | 1 | SCREENING | 2018-06-20 |
|---|
| 3 | XYZ | IS | XYZ1234 | 1 | 19283746 | 2 | ATAB | Autoantibody | NUCLEAR AUTOANTIGENS | NUCLEAR, NUCLEOLAR PATTERN | SCREEN | POSITIVE |
| POSITIVE |
|
| SERUM | FLUORESCENT IMMUNOASSAY | 1 | SCREENING | 2018-06-20 |
|---|
| 4 | XYZ | IS | XYZ1234 | 2 | 19283746 | 2 | ATAB | Autoantibody | NUCLEAR AUTOANTIGENS | NUCLEAR, NUCLEOLAR PATTERN | QUANTIFY | 1:340 |
| 340 | 340 | titer | SERUM | FLUORESCENT IMMUNOASSAY | 1 | SCREENING | 2018-06-20 |
|---|
| 5 | XYZ | IS | XYZ1234 | 1 | 19283746 |
| ATAB | Autoantibody | NUCLEAR AUTOANTIGENS | NUCLEAR, CENTROMERE PATTERN | SCREEN | NEGATIVE |
| NEGATIVE |
|
| SERUM | FLUORESCENT IMMUNOASSAY | 1 | SCREENING | 2018-06-20 |
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Decisions and Additional Notes/Action Items:
...