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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 for TB study have to be TB1/2 Antigens. This is just an example to show which variable to populate which type of data 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 |
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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 | NHOID | STUDYID | DOMAIN | USUBJID | SPDEVID | ISSEQ | ISGRPID | ISLNKID | ISTESTCD | ISTEST | ISTSTCND | ISCNDAGT | ISTSTDTL | ISORRES | ISORRESU | ISSTRESC | ISSTRESN | ISSTRESU | ISSPEC | ISMETHOD | ISDTC |
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1 |
| ABC | IS | ABC-01-203 | ABC001 | 1 | 1 | B | IFNG | Interferon Gamma | WITHOUT STIMULATING AGENT |
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| IU/mL |
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| 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 |
| 0.9 | IU/mL | 0.9 | 0.9 | 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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