Clin Chem Lab Med. 2026 Jan 6. doi: 10.1515/cclm-2025-1605. Online ahead of print.

ABSTRACT

OBJECTIVES: Lipoprotein(a) is an atherogenic particle causative of atherosclerotic cardiovascular disease. Novel treatments have been developed that lower lipoprotein(a) to unprecedented levels with cardiovascular outcomes trials ongoing. Many guidelines recommend testing once in the lifetime of everyone, but testing rates remain low. In this study we compare a lipoprotein(a) point of care testing device to laboratory analysers and assess its performance.

METHODS: Lipoprotein(a) concentrations on residual patient samples measured on the Randox and Roche assays were compared to a novel point of care device, iProtin. Furthermore, assessment of iProtin performance characteristics were performed, including intra- and inter-assay coefficient of variation and dilutional studies.

RESULTS: Lipoprotein(a) concentrations measured on the Randox and Roche assays showed strong correlation with iProtin. Regression analysis using Passing-Bablock showed the best fits for iProtin based on 58 serum samples were: 1.15 × Randox + 7.28 nmol/L and 1.02 × Roche + 17.54 nmol/L. The R² values for Randox/iProtin and Roche/iProtin were 0.906 and 0.912 respectively. Correlation between Roche and Randox showed Roche=1.15 × Randox – 13.33 nmol/L with an R² value of 0.973. Inter-assay coefficient of variation of the iProtin device showed a day-to-day imprecision over 5 days of 15.5 % (low concentration quality control) and 6.2 % (high concentration quality control). Within day imprecision was 13.2 % (lower concentration patient sample) and 14.3 % (higher concentration patient sample).

CONCLUSIONS: Point of care testing could be a complimentary option to laboratory testing of lipoprotein(a), especially in remote areas. It may help (re-)stratify cardiovascular risk and help tailor treatment decisions.

PMID:41486066 | DOI:10.1515/cclm-2025-1605