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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 neccessarily necessarily end up with a testkit/instrument device identifier, since it is the calculation …
Hematology
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analyzer example (e.g. from Abbott, Coulter, Sysmex).
Used to produce results from CBC panel order
using several reagents, but not all are used for all of these - these would have to be identifed by the vendor which goes with what element
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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
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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)
IVD vendor needs to determine and provide to laboratory customers which reagent(s) is/are used for each test parameters.
Parameters calculated on the instrument: HCT, MCV (Hct * 10/RBC), MCH (Hgb 100/RBC), MCHC (Hgb *100/Hct), RDW, anything with %.
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
Question: Which Reagent Test Identifiers to use?
MCV: Reagent D and Reagent D or None?
MCHC: Reagent D and Reagent H and Reagent D or None?
MCHC: Reagent D and Reagent H and Reagent D or None?
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.
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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
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WBC Count and 3 part differential may be Reagent ED above (is formulation same/different as previous analyzers)?
Questions: Is Alinity 6 part diff Lymphocyte Count # and % Lymphocytes the same or different as Emerald 3 part diff Lymphocyte Count # and % Lymphocytes?
Reminder Alinity uses 2 reagents for Lymp and Emerald uses 1 reagent.
For comingling result values, they are considered the same.