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  1. FHIR Specification Feedback
  2. FHIR-35154

Should value be 0..N instead of 1 for this lab result value? https://loinc.org/95423-0/

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    • Resolution: Not Persuasive
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    Description

      The LOINC https://loinc.org/95423-0/

      upon which this item is based has a value set for responses here:  http://hl7.org/fhir/us/covid19library/2022Jan/ValueSet-fluAB-SARSCoV2-value-set.html

       

      Given a patient can have 1, 2, 3, or none of the viruses tested, doesn't the cardinality need to be 0..N in instances where more than one virus is detected in a patient with this test method and reported? (i.e. Flu A and COV2 dual infection, or FluA and FluB dual infection or all 3)?

      In the CDC/SHIELD LIVD file, this LOINC is mapped to the Roche Cobas 6800 assay used by Quest Diagnostics:  https://diagnostics.roche.com/us/en/products/params/cobas-sars-cov-2-influenza-a-b-test.html    

      Although it looks like Quest structures this assay to report out unique result items (with different LOINCs) and their values for this assay currently on their website.  Roche's website indicates each virus can be distinctly identified qualitatively (which is different than this LOINC as a nom response with the viruses listed, but that is a LIVD mapping issue) and this is not a pan assay. 

      See also Quest's possible result description which would be repeated with same LOINC as separate result values depending how many are detected by the assay:

      No target RNA Detected (260415000^Not Detected^SCT)
      Influenza B RNA Detected (407480007^Influenza B virus^SCT)
      Influenza A RNA Detected (407479009^Influenza A virus^SCT)
      Influenza A and Influenza B RNA Detected (407479009^Influenza A virus^SCT and 407480007^Influenza B virus^SCT)
      Presumptive Positive for SARS-CoV-2 RNA (868196001^Subgenus Sarbecovirus^SCT)
      Presumptive Positive for SARS-CoV-2 RNA and Influenza B RNA Detected (868196001^Subgenus Sarbecovirus^SCT and 407480007^Influenza B virus^SCT)
      Influenza A RNA Detected and Presumptive Positive for SARS-CoV-2 RNA (407479009^Influenza A virus^SCT and 868196001^Subgenus Sarbecovirus^SCT)
      Influenza A RNA Detected, Presumptive Positive for SARS-CoV-2 RNA, and Influenza B RNA Detected (407479009^Influenza A virus^SCT and 868196001^Subgenus Sarbecovirus^SCT and 407480007^Influenza B virus^SCT)
      SARS-CoV-2 RNA Detected (840533007^Severe acute respiratory syndrome coronavirus 2^SCT)
      SARS-CoV-2 RNA and Influenza B RNA Detected (840533007^Severe acute respiratory syndrome coronavirus 2^SCT and 407480007^Influenza B virus^SCT)
      Influenza A RNA and SARS-CoV-2 RNA Detected (407479009^Influenza A virus^SCT and 840533007^Severe acute respiratory syndrome coronavirus 2^SCT)
      Influenza A RNA and SARS-CoV-2 RNA Detected (407479009^Influenza A virus^SCT and 840533007^Severe acute respiratory syndrome coronavirus 2^SCT)
      Influenza A RNA, SARS-CoV-2 RNA, and Influenza B RNA Detected (407479009^Influenza A virus^SCT and 840533007^Severe acute respiratory syndrome coronavirus 2^SCT and 407480007^Influenza B virus^SCT)
      Invalid (455371000124106^Invalid result^SCT or 125154007^Specimen unsatisfactory for evaluation^SCT)

       

      Another LIVD test mapped to this LOINC is CDC's assay:  https://www.fda.gov/media/139744/download

      Unfortunately, it's not clear from the EU whether this is reported as flu a-pos, neg, indeterminate; flu b-pos, neg, indeterminate like Quest with separate other LOINCs for the results  or if this might be reported as a result of "flu a, flu b, and/or covid 19" (like the LOINC indicates) with a result value of "flu a", and/or "flu b" and/or COVID and or negative for all, or indeterminant, which might be mapped to this LOINC and have one or more of the responses values as listed in the value set?

       

      So to summarize, it looks like the value set needs to be 0..N (or 1 to N as some value if if not detected or indeterminate is used would be reported).

       

      Secondly, the linked value set for this LOINC/test result/assay lists only a few of the values that Quest indicates they report.  Either Quest needs to map to another LOINC (if another fits-didn't research)  I'm assuming the mapping is correct.  In that case, the Logica "test result" needs to be updated to support.  The easiest way is to not list response values in a value set (unless you want the term to only reflect that single combo of LOINC and responses)?  In that case, another Logica term is needed to reflect the same LOINC with the different response value sets depending on which test is performed (CDC assay or Quest's on the Roche analyzers).

       

      Due to time constraints analysis was only performed on this code/term and the entire COVID lab library may need further review to determine scope of impact.

       

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            apitkus Andrea Pitkus
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