Establishing serum proprotein convertase Subtilisin/Kexin type 9 (PCSK9) reference intervals

Area of Science:

• Cardiovascular Disease Research
• Lipid Metabolism Studies
• Biomarker Discovery

Background:

• Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) is crucial for lipid metabolism and a cardiovascular disease therapeutic target.
• Established reference intervals (RIs) for circulating PCSK9 are lacking, hindering clinical and research applications.
• This study aimed to establish serum PCSK9 RIs in a healthy adult population.

Purpose of the Study:

• To establish serum PCSK9 reference intervals (RIs) in a healthy adult population.
• To investigate the influence of demographic and biological variables on PCSK9 levels.
• To provide a foundation for the clinical interpretation of PCSK9 measurements.

Main Methods:

• Recruited 132 healthy adults (aged 18-65) with normal lipid profiles and no relevant medical history.
• Measured serum PCSK9 concentrations using a validated ELISA assay.
• Applied statistical analyses, including CLSI guideline-compliant RI calculation and sex/age stratification.

Main Results:

• The mean serum PCSK9 level was 428 ± 119 ng/mL.
• PCSK9 concentrations were significantly higher in women than in men.
• A moderate positive correlation was observed between PCSK9 levels and age (r=0.36, p<0.001).
• Overall RIs ranged from 201 to 659 ng/mL; stratified RIs revealed significant sex- and age-related differences.

Conclusions:

• This study presents the first rigorously derived reference intervals for serum PCSK9 in a healthy Caucasian population.
• Observed variations in PCSK9 levels by sex and age emphasize the necessity of personalized reference values.
• These findings support the clinical utility of PCSK9 measurements in cardiovascular risk assessment.