Biological variation of proprotein convertase subtilisin/kexin type 9 (PCSK9) in human serum.

• Within-subject biological variation of PCSK9 in human serum was 23.2%, between-subject biological variation was 10.9%. • Index of individuality was 2.13, thus enabling the use of reference intervals. • Reference change value was 66.3%. • The estimation of homeostatic point can be based on at least...

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Bibliographic Details
Published in:Clinica Chimica Acta Vol. 521; pp. 59 - 64
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Format: Article
Published: Elsevier B.V., Oct2021
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Summary:• Within-subject biological variation of PCSK9 in human serum was 23.2%, between-subject biological variation was 10.9%. • Index of individuality was 2.13, thus enabling the use of reference intervals. • Reference change value was 66.3%. • The estimation of homeostatic point can be based on at least 3 blood samples to assess its value within ±25%. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is involved in the regulation of LDL receptors. Inhibition of PCSK9 increase uptake of LDL-particles and pathogen-associated molecular patterns (PAMPs). The aim of our study was to evaluate biological variation of serum PCSK9. Within-subject (CV I) and between-subject (CV G) biological variations were assessed in 14 healthy volunteers in a 6-week protocol (7 samples, equidistant time intervals). Serum concentration of PCSK9 was measured by a Quantikine ELISA assay (R&D systems, Bio-Techne Ltd., UK) on a DS2 ELISA reader (Dynex Technologies GmbH, Germany). Precision (CV A) was assessed by duplicate measurements. Two methods with different levels of robustness were used for the estimation of CV I , SD-ANOVA and CV-ANOVA method. We calculated the index of individuality and reference change values. The experiment was fully compliant with EFLM database checklist. The within-subject values of PCSK9 in healthy persons, as calculated by two statistical methods, were 23.2% (SD-ANOVA with CV A of 5.6%) and 26.6% (CV-ANOVA with CV A of 4.8%). The CV G was 10.9% (SD-ANOVA), index of individuality and RCV were 2.13 and 66.3%, respectively. The high index of individuality indicates that common reference intervals can be used to interpret serum PSCK9 values.