Before you submit ‘Indirect bilirubin [Moles/volume] in Serum or Plasma by Direct assay’ to Regenstrief, please check Ortho Clinical’s customer service for their LOINC terms? The larger IVD manufacturers have been working internally to identify the correct LOINC terms for their assays. I tried to look online at their technical documents to determine how they chemically directly measure indirect (non-glucuronidated) bilirubin; couldn’t locate the package inserts for reagents on VITROS machine. Regenstrief would need that package insert as well if it’s necessary to submit.
The method of “Direct assay” has only been assigned to LDL Cholesterol in LOINC. The submission would need to make a solid case that direct measurement in this instance is to be kept separate from values measured differently.
Thank you for your discussion!
Best regards,