Testing
New point-of-care device shows strong correlation with lab Lp(a) assays, validation study of 58 samples (Clin Chem Lab Med 2026)
Original title: Measurement of lipoprotein(a) via a novel point of care approach with comparison to established laboratory assays
Comparative validation study of iProtin, a novel point-of-care Lp(a) testing device, against Randox and Roche laboratory assays using 58 residual serum samples. Passing-Bablok regression gave iProtin = 1.15 x Randox + 7.28 nmol/L (R2 0.906) and iProtin = 1.02 x Roche + 17.54 nmol/L (R2 0.912), while Roche correlated with Randox as Roche = 1.15 x Randox - 13.33 nmol/L (R2 0.973). iProtin's inter-assay coefficient of variation over 5 days was 15.5% at low and 6.2% at high concentration quality control; within-day imprecision was 13.2% (lower patient sample) and 14.3% (higher patient sample). The authors conclude point-of-care Lp(a) testing could complement laboratory testing, particularly in remote areas, helping identify and treat patients who would otherwise go untested.
Original 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.
Summary written by lp-a.org from the published abstract; figures as published. Page updated 17 August 2026. Methods.