Request | Notes | Status |
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User Inquiry: Yun Zhang <Yun.Zhang@modernatx.com> | From Yun: Hepatitis B screening panel includes Hepatitis B surface antigen, Hepatitis B Surface antibody, Hepatitis B core antibody. If those tests are only done at screening and not related to study interest disease. If following IG 3.3 , all those 3 tests are mapped to MB. If following IG 3.4, will only antigen map to MB , those 2 antibody tests are mapped to IS ? But in this way the same panel test would be separated in two domains. Do you have any suggestions ? Here is the link to the test: https://testdirectory.questdiagnostics.com/test/test-guides/TS_HBVScreen/hbv-screen-panel-with-reflexes
2024-02-22 team notes - we also talked about making a new variable called “Panel Testing” which would apply to all the specimen-based domains. In recent years we have seen other panel tests that would required tests to be mapped to, for instance, GF and MB. It would be nice to have a standard variable dedicated to grouping related records from the same panel test, instead of having to rely on CAT or linking variables. | 2024-02-22: Jordan sent the mockup example back to Yun.
Action Item: - Jordan needs to add this to Example Collection.
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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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Rows 1-2: | Show the screening, followed by confirmatory detection of Influenza A virus RNA in a nasal specimen by Rapid PCR test. | Row 3: | Shows viral load of the previously detected Influenza A virus RNA. | Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | MBSEQ |
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MBGRPIDMBLNKID | MBTESTCD | MBTEST | MBTSTDTL | MBTSTOPO | MBCAT | MBORRES |
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MBORRESUMBSTRESN | MBSTRESU | MBSPEC | MBLOC | VISITNUM0011 | INFARNA | Influenza A RNA | DETECTION | SCREEN | MICROBIOLOGY | YES | YES | YES | MUCUS | NOSTRIL | RAPID PCR | 1 | SCREEN | 2018-06-01HBVP1 |
| Hepatitis B Virus Surface Antigen | DETECTION |
| HBV TRIPLE SCREEN PANEL | POSITIVE | POSITIVE |
| SCREENING | 2013-08-26 | 2 | ABC | MB | ABC-01- | 00131INFARNA | Influenza A RNA | DETECTION | CONFIRM | MICROBIOLOGY | YES | YES | YES | log 10 IU/mL | MUCUS | NOSTRIL | RAPID PCR | 1 | SCREEN |
| Hepatitis B Virus | INTERPRETATION | SCREEN | HBV TRIPLE SCREEN PANEL | ACUTE INFECTION | ACUTE INFECTION |
| SCREENING | 2013-08-26 | 2018-06-0100112 | INFARNA | Influenza A RNA | VIRAL LOAD | QUANTIFY | MICROBIOLOGY | 4.5 | log 10 copies/mL | 4.5 | 4.5 | log 10 copies/mL | MUCUS | NOSTRIL | QUANTITATIVE REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION | 1 | SCREEN | 2018-06-01 | HBVP2 |
| Hepatitis B Virus Surface Antigen | DETECTION |
| HBV TRIPLE SCREEN PANEL | POSITIVE | POSITIVE |
| VISIT 1 | 2013-10-25 | 4 | ABC | MB | ABC-01-203 | 4 | HBVP2 |
| Hepatitis B Virus | INTERPRETATION | SCREEN | HBV TRIPLE SCREEN PANEL | ACUTE INFECTION | ACUTE INFECTION |
| VISIT 1 | 2013-10-25 |
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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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dataset2 | Row | STUDYID | DOMAIN | USUBJID | SPDEVID | ISSEQ |
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ISGRPIDISBDAGNT | ISTSTOPOISORRESUISSTRESN | ISSTRESUVISITNUM | MBDTC0011Antimicrobial IgM SARS-CoV-2 | SCREEN | MICROBIOLOGY | YES | YES | YES | EIA | 1 | SCREEN | 2018-06-01HEPATITIS B VIRUS SURFACE ANTIGEN | HBV TRIPLE SCREEN PANEL | NEGATIVE | NEGATIVE |
| SCREENING | 2013-08-26 | 2 | ABC | IS | ABC | -0013 | 1 | Anti-microbial IgM Antibody | SARS-CoV2QUANTIFY | MICROBIOLOGY | 350 | Titer | 350 | 350 | Titer | EIA | 1 | SCREEN | 2018-06- | |
The LB drug tox screen example of TSTPOP.
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ug/L
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The IS ADA example using TSTPOP.
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-203 | ABC001 | 2 | HBVP1 |
| Microbial-induced IgM Antibody | HEPATITIS B VIRUS CORE ANTIGEN | HBV TRIPLE SCREEN PANEL | POSITIVE | POSITIVE |
| SCREENING | 2013-08-26 | 3 | ABC | IS | ABC-01-203 | ABC001 | 3 | HBVP1 |
| Microbial-induced Total Antibody | HEPATITIS B VIRUS CORE ANTIGEN | HBV TRIPLE SCREEN PANEL | POSITIVE | POSITIVE |
| SCREENING | 2013-08-26 | 4 | ABC | IS | ABC-01-203 | ABC001 | 4 | HBVP2 |
| Microbial-induced Antibody | HEPATITIS B VIRUS SURFACE ANTIGEN | HBV TRIPLE SCREEN PANEL | NEGATIVE | NEGATIVE |
| VISIT 1 | 2013-10-25 | 5 | ABC | IS | ABC-01-203 | ABC001 | 5 | HBVP2 |
| Microbial-induced IgM Antibody | HEPATITIS B VIRUS CORE ANTIGEN | HBV TRIPLE SCREEN PANEL | NEGATIVE | NEGATIVE |
| VISIT 1 | 2013-10-25 | 6 | ABC | IS | ABC-01-203 | ABC001 | 6 | HBVP2 |
| Microbial-induced Total Antibody | HEPATITIS B VIRUS CORE ANTIGEN | HBV TRIPLE SCREEN PANEL | POSITIVE | POSITIVE |
| VISIT 1 | 2013-10-25 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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1 | ABC | MB |
| MBLNID |
| MANY | 1 | 2 | ABC | IS |
| ISLNKID |
| MANY | 1 |
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ISBDAGNT
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ADA_BAB
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Binding Antidrug Antibody
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DRUG AZ-007
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SCREEN
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ANTIDRUG ANTIBODIES
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DRUG AZ-007
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CONFIRM
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ADA_BAB
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Binding Antidrug Antibody
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DRUG AZ-007
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ANTIDRUG ANTIBODIES
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