ELISA:
| Warning |
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| title | Updates for SDTMIG 4.0 |
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When this example is moved to the IG, make sure to update IS assumption #6: Measurements of cytokines, chemokines, and complement proteins should be represented in the Laboratory Test Results (LB) domain. Need to explain when to use IS vs LB for cytokine tests. See notes #3 below. |
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If we were to model this in IS:
ELISA:
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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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Row
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STUDYID
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DOMAIN
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USUBJID
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ISSEQ
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ISGRPID
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ISTESTCD
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ISTEST
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ISCNDAGT
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ISORRES
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ISORRESU
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ISSTRESC
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ISSTRESN
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ISSTRESU
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ISSPEC
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ISMETHOD
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ISDTC
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1
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ABC
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IS
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ABC-01-201
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1
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1
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IFNG
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Interferon Gamma
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1.3
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IU/mL
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1.3
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1.3
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IU/mL
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PLASMA
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ELISA
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2
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ABC
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IS
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ABC-01-201
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2
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1
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Interferon Gamma
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Mycobacterium tuberculosis ESAT-6, CFP-10, TB 7.7
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6.2
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IU/mL
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6.2
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6.2
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IU/mL
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PLASMA
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ELISA
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ABC-01-201
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3
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1
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Interferon Gamma
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Mitogen
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0.9
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IU/mL
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0.9
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0.9
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IU/mL
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PLASMA
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ELISA
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ABC-01-201
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4
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1
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Interferon Gamma
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Positive
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Positive
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PLASMA
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ELISA
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T-Cell ELISPOT:
| 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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| Row | STUDYID | DOMAIN | USUBJID | SPDEVID | ISSEQ | ISGRPID | ISLNKID | ISTESTCD | ISTEST | ISMSCBCE | ISTSTCND | ISCNDAGTISCNDAGT | ISTSTDTL | ISORRES | ISORRESU | ISSTRESC | ISSTRESN | ISSTRESU | ISSPEC | ISMETHOD | ISDTC | LOINC |
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1 | ABC | IS | ABC-01-201 | ABC002 | 1 | 1 |
| CYKSCCL | Cytokine-secreting Cells | INTERFERON GAMMA | WITHOUT STIMULATING AGENT | Nil, no antigen |
| 1 | SFC/10^6 PBMC | 1 | 1 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELLS | ELISPOT | 2013-08-26 |
| 2 | ABC | IS | ABC-01-201 | ABC002 | 2 | 1 |
| CYKSCCL | Cytokine-secreting Cells | INTERFERON GAMMA | STIMULATED | Mycobacterium tuberculosis CFP-10 |
| 13 | SFC/10^6 PBMC | 13 | 13 | SFC/10^6 PBMC | PERIPHERAL BLOOD MONONUCLEAR CELLS | ELISPOT | 2013-08-26 |
| | 3 | ABC | IS | ABC-01-201 | ABC002 | 3 | 1 |
| CYKSCCL | Cytokine-secreting Cells | INTERFERON GAMMA | STIMULATED | Mycobacterium tuberculosis 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 |
| CYKSCCL | Cytokine-secreting Cells | INTERFERON GAMMA | STIMULATED | 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 | MTB001 | CYKSCCL | Cytokine-secreting Cells | INTERFERON GAMMA |
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| InterpretationDetection | Positive |
| Positive |
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| PERIPHERAL BLOOD MONONUCLEAR CELLS | ELISPOT | 2013-08-26 |
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A positive Interferon-gamma (IFN-y) response means the detection to Mycobacterium tuberculosis antigens, suggesting infection with M tuberculosis, see blow:
| 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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| Row | STUDYID | DOMAIN | USUBJID | MBSEQ | MBLNKID | MBTESTCD | MBTEST | MBTSTDTL | MBORRES | MBSTRESC | MBDTC | LOINC |
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1 | ABC | MB | ABC-01-201 | 1 | MTB001 | MTB | Mycobacterium tuberculosis | Interpretation | Detected | Detected | 2013-08-26 | 71773-6 |
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ELISA:
| Dataset wrap |
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| Dataset2 |
|---|
| hi1style | yellow |
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| hi1 | column ISBDAGNT |
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| tableid | IS table 1 |
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| Row | STUDYID | DOMAIN | USUBJID | SPDEVID | ISSEQ | ISGRPID | ISTESTCD | ISTEST | ISTSTCND | ISCNDAGT | ISTSTDTL | ISORRES | ISORRESU | ISSTRESC | ISSTRESN | ISSTRESU | ISSPEC | ISMETHOD | ISDTC |
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1 | ABC | IS |
ABC1230-011ABC-01-201 | ABC001 | 1 | 1 | IFNG | Interferon Gamma | UNSTIMULATED | Nil, no antigen |
| 1.3 | IU/mL | 1.3 | 1.3 | IU/mL |
BLOOD20210510ABC1230-011ABC-01-201 | ABC001 | 2 | 1 | IFNG | Interferon Gamma |
SARS-CoV-2 Antigen or | STIMULATED | Mycobacterium tuberculosis ESAT-6, CFP-10, TB 7.7 |
SARS-CoV-2 Spike ProteinBLOOD20210510ABC1230-011ABC-01-201 | ABC001 | 3 | 1 | IFNG | Interferon Gamma | STIMULATED | Mitogen |
| 0.9 | IU/mL | 0.9 | 0.9 | IU/mL |
BLOOD20210510ABC1230-011ABC-01-201 | ABC001 | 4 | 1 | IFNG | Interferon Gamma |
Interpretation
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| Detection | Positive |
| Positive |
BLOOD20210510 |
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