Standardization of Apolipoprotein B, LDL-Cholesterol, and Non-HDL-Cholesterol

Area of Science:

• Cardiovascular diagnostics
• Clinical chemistry
• Lipidology

Background:

• Concerns exist regarding the standardization of apolipoprotein B (apoB) assays for widespread clinical application.
• Standardization ensures a test accurately, precisely, and selectively measures the intended marker for clinically valid results.

Purpose of the Study:

• To address concerns about apoB measurement standardization.
• To define "standardization" in the context of clinical laboratory testing.
• To advocate for the broader clinical use of apoB testing.

Main Methods:

• Review of expert group determinations on apoB assay standardization.
• Comparison of apoB measurement characteristics (accuracy, precision, selectivity) with LDL-C and non-HDL-C.
• Discussion of ongoing standardization improvements using mass spectrophotometry.

Main Results:

• Multiple expert groups confirm apoB measurement is adequately standardized for clinical care.
• ApoB is measured accurately, precisely, and selectively using inexpensive, widely available automated methods.
• ApoB offers superior standardization compared to LDL-C and non-HDL-C due to its defined molecular structure.

Conclusions:

• Apolipoprotein B measurement is sufficiently standardized for widespread clinical adoption.
• ApoB offers significant advantages in accuracy, precision, and selectivity over traditional cholesterol markers.
• Ongoing standardization efforts will further enhance apoB's utility in managing lipid-lowering therapies.