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Model in IS, if you need to report changes in the actual level of IFN-y or number of IFN-y secreting cells, the stimulating and control agents used in the assay, and a "summary interpretation" result of positive, negative, or indeterminate, etc. In this case, you are testing and recording the explicit changes in the IFN-y release immune response, and this belong in the IS domain.
Example 1: INFy Measure INF-y using T-Cell ELISPOT
| Dataset wrap |
|---|
| Dataset2 |
|---|
| hi1style | yellow |
|---|
| hi1 | column ISBDAGNT |
|---|
| tableid | IS table 1 |
|---|
| Row | 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 |
|
| 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 | MTB 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 | MTB 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 | MTB 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 |
|
| INTERPRETATION | POSITIVE |
| POSITIVE |
|
|
| ELISPOT | 2013-08-26 |
|
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Example 2: INFy Measure INF-y using ELISA
| 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 |
|
| 1.3 | IU/mL | 1.3 | 1.3 | 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 | ESAT-6, CFP-10, TB 7.7 |
| 6.2 | IU/mL | 6.2 | 6.2 | IU/mL | PLASMA | ELISA | 2013-08-26 | | 3 |
| ABC | IS | ABC-01-203 | ABC001 | 3 | 1 | B | IFNG | Interferon Gamma | WITH STIMULATING AGENT | Mitogen |
| 0.9 | IU/mL | 0.9 | 0.9 | IU/mL | PLASMA | ELISA | 2013-08-26 | | 4 |
| ABC | IS | ABC-01-203 | ABC001 | 4 | 1 | B | IFNG | Interferon Gamma |
|
| INTERPRETATION | POSITIVE |
| POSITIVE |
|
|
| ELISA | 2013-08-26 |
|
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Example 3: Identification of Mycobacterium tuberculosis
The MB data below are derived records from the IS dataset above, the identification and diagnosis of Mycobacterium tuberculosis are interpretations based on the IFNy responses test results above.
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