Can Reference Materials Prepared Following CLSI C37-A Be Utilized Without Commutability Assessment? Perspectives Based on Lipid Measurements
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Background: Ensuring reference material (RM) commutability is crucial for evaluating measurement traceability in order to standardize laboratory tests. However, commutability assessment is not routinely performed. We assessed whether RMs prepared following CLSI C37-A guidelines could be used without assessing commutability by evaluating their commutability for four lipid measurements using the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and CLSI EP14 protocols. Methods: We analyzed total cholesterol (TC), triglycerides (TGs), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) in frozen sera from 20 individuals and 11 RMs, prepared by the Korea Disease Control and Prevention Agency- Laboratory Standardization Project (per CLSI C37-A), using six routine measurement pro- cedures (MPs). Regression equations and 95% prediction intervals derived from single-do- nor sera were analyzed following CLSI EP14. The IFCC protocol was used to assess differ- ences in inter-MP biases between RM and clinical samples. The effect of the TG concen- tration on commutability was evaluated by analyzing biases between MP results and refer- ence procedure-assigned values. Results: RMs were commutable for most MP pairs for TC and TG. Commutability for HDL-C and LDL-C varied across RMs, with RM10 and RM11 showing higher TG levels (2.38 and 2.95 mmol/L, respectively) and lower commutability. Increased bias percentages from as- signed values were observed for RMs with higher TG levels. Conclusions: RMs prepared per CLSI C37-A were commutable with most MP pairs for TC and TG. Elevated TG levels affected HDL-C and LDL-C commutability, highlighting the need to consider TG concentrations during RM preparation and assess commutability to stan- dardize laboratory tests.
Abstract
Background: Ensuring reference material (RM) commutability is crucial for evaluating measurement traceability in order to standardize laboratory tests. However, commutability assessment is not routinely performed. We assessed whether RMs prepared following CLSI C37-A guidelines could be used without assessing commutability by evaluating their commutability for four lipid measurements using the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and CLSI EP14 protocols. Methods: We analyzed total cholesterol (TC), triglycerides (TGs), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) in frozen sera from 20 individuals and 11 RMs, prepared by the Korea Disease Control and Prevention Agency- Laboratory Standardization Project (per CLSI C37-A), using six routine measurement pro- cedures (MPs). Regression equations and 95% prediction intervals derived from single-do- nor sera were analyzed following CLSI EP14. The IFCC protocol was used to assess differ- ences in inter-MP biases between RM and clinical samples. The effect of the TG concen- tration on commutability was evaluated by analyzing biases between MP results and refer- ence procedure-assigned values. Results: RMs were commutable for most MP pairs for TC and TG. Commutability for HDL-C and LDL-C varied across RMs, with RM10 and RM11 showing higher TG levels (2.38 and 2.95 mmol/L, respectively) and lower commutability. Increased bias percentages from as- signed values were observed for RMs with higher TG levels. Conclusions: RMs prepared per CLSI C37-A were commutable with most MP pairs for TC and TG. Elevated TG levels affected HDL-C and LDL-C commutability, highlighting the need to consider TG concentrations during RM preparation and assess commutability to stan- dardize laboratory tests.