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User Inquiry:

"I wanted to revisit this discussion on ANA pattern reporting. We also deal with testing labs where they pre-coordinate the pattern result into the test name and perform a call of whether the pattern is observed or not. For example, the 'test' the lab performs evaluates each staining pattern as listed below:

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1. This approach allows the users to report both the "specific, pre-specified" positive and negative patterns.
2. This is also almost a 1:1 mapping to LOINC codes.
3. Consistent modeling approach across specimen-based domains.

Supporting LOINC Codes:

• https://loinc.org/53994-0/ Presence

• https://loinc.org/96921-2/ Titer

  Example
  title IS Example 2
  Dataset wrap Name IS Dataset2 Row STUDYID DOMAIN USUBJID ISSEQ ISREFID ISGRPID ISTESTCD ISTEST ISBDAGNT ISTSTDTL ISTSTOPO ISORRES ISORRESU ISSTRESC ISSTRESN ISSTRESU ISSPEC ISMETHOD VISITNUM VISIT ISDTC 1 XYZ IS XYZ1234 1 19283746 1 ATAB Autoantibody NUCLEAR AUTOANTIGENS CYTOPLASMIC, SPECKLED PATTERN SCREEN POSITIVE POSITIVE SERUM FLUORESCENT IMMUNOASSAY 1 SCREENING 2018-06-20 2 XYZ IS XYZ1234 2 19283746 1 ATAB Autoantibody NUCLEAR AUTOANTIGENS CYTOPLASMIC, SPECKLED PATTERN QUANTIFY 1:170 170 170 titer SERUM FLUORESCENT IMMUNOASSAY 1 SCREENING 2018-06-20 3 XYZ IS XYZ1234 1 19283746 2 ATAB Autoantibody NUCLEAR AUTOANTIGENS NUCLEAR, NUCLEOLAR PATTERN SCREEN POSITIVE POSITIVE SERUM FLUORESCENT IMMUNOASSAY 1 SCREENING 2018-06-20 4 XYZ IS XYZ1234 2 19283746 2 ATAB Autoantibody NUCLEAR AUTOANTIGENS NUCLEAR, NUCLEOLAR PATTERN QUANTIFY 1:340 340 340 titer SERUM FLUORESCENT IMMUNOASSAY 1 SCREENING 2018-06-20 5 XYZ IS XYZ1234 1 19283746 ATAB Autoantibody NUCLEAR AUTOANTIGENS NUCLEAR, CENTROMERE PATTERN SCREEN NEGATIVE NEGATIVE SERUM FLUORESCENT IMMUNOASSAY 1 SCREENING 2018-06-20

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• Team is happy with both approaches, this "reciprocal" modeling approach provides flexibility and allows sponsors to accommodate different data collection schemas. It is also highly consistent with LOINC, both example have LOINC codes corroboration.
• Jordan to enter this into the CDISC Example Libraryalready added this one to the SDTMIG v4.0.

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