Determination of lipemia acceptance thresholds for 31 immunoassay analytes.

Background: Lipemia is one of common endogenous interferences that can compromises sample quality and potentially influence results of various laboratory methods. Determination of the lipemic index or triglyceride concentrations are used to define the degree of lipemia. This study was aimed to establish lipemic index (LI) and triglyceride thresholds above where significant interference exists for 31 immunoassay analytes measured on Roche Cobas 6000.

Materials And Methods: The study was carried out following CLSI C56-A and EP07-ED3:2018 guidelines using sample pools spiked with increasing concentrations of lipid emulsion solution, reaching 70 mmol/L. To define the LI and triglyceride thresholds, the bias from concentration in the native sample was calculated at different lipemia degree and compared with allowable error limits based on biological variation or state-of-the-art technology.

Results: No lipemia interference was observed for 27 out of 31 analytes even at the highest concentrations of lipid emulsion (LI ranging from 1737 to 2086 mg/dL, triglyceride concentration 60.34-73.99 mmol/L). However, progesterone, 25-OH vitamin D, testosterone, and estradiol were negatively affected by lipemia at 217 mg/dL (9.58 mmol/L), 222 mg/dL (10.66 mmol/L), 478 mg/dL (18.81 mmol/L), and 941 mg/dL (35.82 mmol/L) of the LI (triglyceride concentration), respectively.

Conclusion: Most immunoassays evaluated in this study were found to be robust to lipemia interference. By using these thresholds, laboratories can report the immunoassay results from analyzing a lipemic patient sample in many cases.