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There is quite a bit of push back on this data element

Should support testkit and instrument device identifiers, in order to accommodate different patterns

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

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

What level of identification is needed:

  • manufacturer / model

  • device identifier of UDI

  • production identifier of UDI (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

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

image-20240216-233223.png

  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.

image-20240217-000226.png

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

image-20240217-000436.png

image-20240217-000252.png

  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.