| Request | Notes | |
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Update Examples from TB-TAUG.
| Remodel this assay and data in IS. Fix modeling mistakes in the TB TAUG Also requested by Joleen White | |
- Feedback from Ivan Jiang Ivan Jiang , whose study team had reviewed this example.
| See his feedback in the comment section.See his feedback in the comment section. 2023-09-07: - Decision: We are not going to update the example. We will clarify in the example description that: ISCNDAGT is NOT controlled so this could be ESAT-6, CFP-10 or other peptide (instead of TB1 and TB2 Antigens). We are not suggesting that the stimulating agents used for TB IFN-y test have to be TB1/2 Antigens. This is just an example to show which variable needs to be used to populate which type of data, in order to make a meaningful and unique record. It is up to the sponsor to decide what collected value should be mapped to ISCNDAGT.
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| colour | Yellow |
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| title | Follow-up Needed |
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Action Item: Jordan to update example description when moving to Example Collection.
| | Status |
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| colour | Green |
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| title | In progressResolved |
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Ivan: Need team review.
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- Joleen Joleen White requested to update the example as well. Questions about specimen info in this example.
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| | Status |
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| colour | Yellow |
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| title | In progress |
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Joleen: Need team review. |
| Warning |
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| title | Updates for SDTMIG 4.0 |
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Make sure to update IS assumption #6: Measurements of cytokines, chemokines, and complement proteins should be represented in the Laboratory Test Results (LB) domain. We need to draft a language to describe when to use IS vs MB vs LB for cytokine tests. : IS assumption 6 has been updated. |
We recently received this request: SARS CoV-2 stimulated gamma interferon [Presence] in Blood (https://loinc.org/95971-8/). We also received requests for the following LOINC codes: 95974-2, 95972-6, and 95973-4. Upon further research on all 4 LOINC codes, they are referring to the IFN-y Release Assay (IGRA), which has been modeled in the LB domain in both TB-TAUGs V1 and V2.
...
| Dataset wrap |
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| Dataset2 |
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| hi1style | yellow |
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| hi1 | column ISBDAGNT |
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| tableid | IS table 1 |
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| NHOID | STUDYID | DOMAIN | USUBJID | SPDEVID | ISSEQ | ISGRPID | ISLNKID | ISTESTCD | ISTEST | ISMSCBCE | ISTSTCND | ISCNDAGT | ISTSTDTL | ISORRES | ISORRESU | ISSTRESC | ISSTRESN | ISSTRESU | ISSPEC | ISMETHOD | ISDTC |
|---|
1 | ABC | IS | ABC-01-201 | ABC002 | 1 | 1 | A | CYKSCCL | Cytokine-secreting Cells | INTERFERON GAMMA | WITHOUT STIMULATING AGENT |
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| 1 | SFC/10^6 PBMC | 1 | 1 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELLS | ELISPOT | 2013-08-26 | 2 |
Mycobacterium tuberculosis 13-Cr5_ND_6_A | ABC | IS | ABC-01-201 | ABC002 | 2 | 1 | A | CYKSCCL | Cytokine-secreting Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | CFP-10 |
| 13 | SFC/10^6 PBMC | 13 | 13 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELLS | ELISPOT | 2013-08-26 | | 3 |
Mycobacterium tuberculosis 13-Cr5_ND_6_A | ABC | IS | ABC-01-201 | ABC002 | 3 | 1 | A | CYKSCCL | Cytokine-secreting Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | ESAT-6 |
| 17 | SFC/10^6 PBMC | 17 | 17 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELLS | ELISPOT | 2013-08-26 | | 4 | ABC | IS | ABC-01-201 | ABC002 | 4 | 1 | A | CYKSCCL | Cytokine-secreting Cells | INTERFERON GAMMA | WITH STIMULATING AGENT | Mitogen |
| 30 | SFC/10^6 PBMC | 30 | 30 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELLS | ELISPOT | 2013-08-26 | | 5 | ABC | IS | ABC-01-201 | ABC002 | 5 | 1 | A | CYKSCCL | Cytokine-secreting Cells | INTERFERON GAMMA |
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| INTERPRETATION | POSITIVE |
| POSITIVE |
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| ELISPOT | 2013-08-26 |
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Example 2: Measure INF-y using ELISA
Jordan Li When moving this example to the Example Collection for internal and public review, update the example description to mention that: ISCNDAGT is NOT controlled so this could be ESAT-6, CFP-10 or other peptide (instead of TB1 and TB2 Antigens). We are not suggesting that the stimulating agents used for TB IFN-y test have to be TB1/2 Antigens. This is just an example to show which variable needs to be used to populate which type of data, in order to make a meaningful and unique record. It is up to the sponsor to decide what collected value should be mapped to ISCNDAGT.
| Dataset wrap |
|---|
| Dataset2 |
|---|
| hi1style | yellow |
|---|
| hi1 | column ISBDAGNT |
|---|
| tableid | IS table 1 |
|---|
| Row NHOID | STUDYID | DOMAIN | USUBJID | SPDEVID | ISSEQ | ISGRPID | ISLNKID | ISTESTCD | ISTEST | ISTSTCND | ISCNDAGT | ISTSTDTL | ISORRES | ISORRESU | ISSTRESC | ISSTRESN | ISSTRESU | ISSPEC | ISMETHOD | ISDTC |
|---|
1 | ABC | IS | ABC-01-203 | ABC001 | 1 | 1 | B | IFNG | Interferon Gamma | WITHOUT STIMULATING AGENT |
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| 0.9 | IU/mL | 0.9 | 0.9 | IU/mL | PLASMA | ELISA | 2013-08-26 | 2 Mycobacterium tuberculosis | ABC | IS | ABC-01-203 | ABC001 | 2 | 1 | B | IFNG | Interferon Gamma | WITH STIMULATING AGENT | TB1 Antigen |
| 6.2 | IU/mL | 6.2 | 6.2 | IU/mL | PLASMA | ELISA | 2013-08-26 | 3 Mycobacterium tuberculosis | ABC | IS | ABC-01-203 | ABC001 | 2 | 1 | B | IFNG | Interferon Gamma | WITH STIMULATING AGENT | TB2 Antigen |
| 9.8 | IU/mL | 9.8 | 9.8 | IU/mL | PLASMA | ELISA | 2013-08-26 | | 4 | ABC | IS | ABC-01-203 | ABC001 | 3 | 1 | B | IFNG | Interferon Gamma | WITH STIMULATING AGENT | Mitogen |
| 0.95 | IU/mL | 0.9 | 5 | 50.9 | IU/mL | PLASMA | ELISA | 2013-08-26 | | 5 | ABC | IS | ABC-01-203 | ABC001 | 4 | 1 | B | IFNG | Interferon Gamma |
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| INTERPRETATION | POSITIVE |
| POSITIVE |
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|
| ELISA | 2013-08-26 |
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|
...