Issues this data element is aiming to solve:

• Linking instance data to LIDR entries

• Identifying test kit issues for EUAs to better understand these new tests or in post market surveillance of 510k = Real World Data

• Allowing to decide if results can be combined (harmonized methods)

  • need to determine the key items needed for this effort

  • CDC’s Harmonization effort for lipid testing has been tracking instrument and reagents and calibrators at the lot number level - but has not been seeing much benefit of tracking this at the lot level

    • the list of parameters that helps them find what is comparable: https://www.cdc.gov/labstandards/csp/pdf/crmln/MFR_TC-AK_CRMLN-508.pdf

      • seems to be manufacturer and model - if taking off the lot numbers etc

What level of identification is needed:

• manufacturer / model

• Global Trade Identificatin Number (GTIN) - provided by GS1 - can be used as UDI

• UDI

  • device identifier

  • production identifier (serial number or lot number)

  • full UDI

Lab tests not covered by UDI

• Lab developed tests (some of them may be coverable)

• manual assessment of specimen (urin color / clarity, specimen characteristics (gradeing hemolysis, lipemia), grossing)

• calculations (if it is not performed by the instrument)

• not EVERY result needs a Unique identifier

  • https://loinc.org/65634-8/ or https://loinc.org/34535-5/

    • in both of these the map to LOINCs would not necessarily end up with a testkit/instrument device identifier, since it is the calculation …

Hematology analyzer example (e.g. from Abbott, Coulter, Sysmex).

Used to produce results from CBC panel order

1. https://loinc.org/58410-2/

2. Some are directly measured by the instrument, while others are calculated on the instrument.

Instrument (large footprint for high volume//large labs):

https://www.corelaboratory.abbott/int/en/offerings/brands/alinity/Alinity-h-hematology-system.html

1. Need to determine which reagents (above) are used solely or in combination with other reagents to produce each test result value (each reportable parameter above)

   1. IVD vendor needs to determine and provide to laboratory customers which reagent(s) is/are used for each test parameters.

2. Parameters calculated on the instrument: HCT, MCV (Hct * 10/RBC), MCH (Hgb 100/RBC), MCHC (Hgb *100/Hct), RDW, anything with %.

3. Question: Which Reagent Test Identifiers to use? Hgb, Reagent D used for RBC, Reagent D used for HcT, Reagent D and Reagent H used for Hgb

4. Question: Which Reagent Test Identifiers to use?

   1. MCV: Reagent D and Reagent D or None?

   2. MCHC: Reagent D and Reagent H and Reagent D or None?

   3. MCHC: Reagent D and Reagent H and Reagent D or None?

   4. WBC, Neu, %Neu, Lym, %Lym, Mono, %Mono, Eo, %Eo, Baso, %Baso, IG, %IG: Reagent D and Reagent W for all parameters in 6 part Diff and WBC

Consider a medium lab footprint hematology analyzer (medium volume): https://www.corelaboratory.abbott/int/en/offerings/brands/cell-dyn/cell-dyn-ruby.html 4 reagents, CBC parameters and differential as before.

Consider a small lab footprint hematology analyzer (lower volume): https://www.corelaboratory.abbott/int/en/offerings/brands/cell-dyn/cell-dyn-emerald.html 3 part diff. 3 reagents for CBC parameters

1. WBC Count and 3 part differential may be Reagent ED above (is formulation same/different as previous analyzers)?

2. Questions: Is Alinity 6 part diff Lymphocyte Count # and % Lymphocytes the same or different as Emerald 3 part diff Lymphocyte Count # and % Lymphocytes?

   1. Reminder Alinity uses 2 reagents for Lymp and Emerald uses 1 reagent.

   2. For comingling result values, they are considered the same.