Point-of-care testing compared to gold-standard laboratory methods in the measurement of serum lipids.

Abstract

Background: Cardiovascular disease is the leading cause of mortality worldwide, with dyslipidaemia being one of the major risk factors. Point-of-care testing (POCT) allows for the rapid measurement of serum lipids. The aim of this study was to assess the accuracy of serum lipid measurement by the Fujifilm^™ NX700 POCT compared to a gold-standard clinical laboratory method (Medpace, Leuven, Belgium).

Methods: This was a prospective, observational study conducted at the Lipid Clinic at Charlotte Maxeke Johannesburg Academic Hospital from July to September 2022. Participants were known to have a lipid disorder, most commonly, familial hypercholesterolaemia. Samples sent for lipid measurement by standard laboratory methods were simultaneously measured by the Fujifilm^™ NX700 POCT.

Results: Lipograms evaluating total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C) and calculated low-density lipoprotein cholesterol (LDL-C) were obtained from 115 participants. No statistically significant difference was noted between the parameters tested on the different platforms. The Fujifilm^™ NX700 POCT correctly identified > 91% of serum lipid results as normal or abnormal, as defined by NCEP-ATP III criteria, and exhibited good sensitivity and specificity for each parameter. Lin's concordance correlation coefficient demonstrated a strong correlation for all parameters; TC (ρ_c = 0.9861), HDL-C (ρ_c = 0.95919), LDL-C (ρ_c = 0.98134) and TG (ρ_c = 0.92775). Bland-Altman plots identified low bias and a good level of agreement between the two test methods.

Conclusion: The Fujifilm^™ NX700 POCT compared favourably with gold-standard laboratory methods in the determination of serum lipid measurements, allowing for rapid screening at the primary healthcare level.