Abstract

The determination of lipid biomarkers by capillary sampling may be useful in the screening, diagnosis and/or personal management of hyperlipidemia and cardiovascular risk. It remains unclear whether the use of the Accutrend Plus system is appropriate. This study aimed to assess its reproducibility, accuracy and concordance for blood lipid profiling in adults. Fasting capillary total cholesterol (TC) and triglyceride (TG) concentration on Accutrend Plus were compared with their venous analogues obtained by a laboratory reference method in sixty-one adults (27 men and 34 women, aged 33.0 years). Supplementary capillary sampling was performed at two consecutive days taking into account macro-nutrient intake. The day-to-day reproducibility of the Accutrend Plus system proved to be high for TC (ICC = 0.85, P < 0.001), but moderate for TG (ICC = 0.68, P < 0.001). Strong correlations (r > or = 0.80, P < 0.001) with the reference method were found for TC and TG. Mean difference (limits of agreement) were: 0.26 mmol/L (-0.95, 1.47) for TC, and -0.16 mmol/L (-1.29, 0.98) for TG. The concordance for subject classification according to the National Cholesterol Education Program (NCEP) guidelines was significant (P < 0.001), with substantial agreement for TC (K(w) = 0.67), and moderate agreement for TG (K(w) = 0.50). Day-to-day reproducibility of the Accutrend Plus device for TC and TG is not optimal and lacks accuracy when compared to the reference laboratory method. The concordance between both methods for classifying subjects according to the NCEP is inadequate. Accutrend Plus device should not be interchangeably used as a substitution for the standard laboratory methods in the diagnosis of hyperlipidemia.

Highlights

  • The determination of lipid biomarkers by capillary sampling may be useful in the screening, diagnosis and/or personal management of hyperlipidemia and cardiovascular risk

  • The detection, evaluation and treatment of hyperlipidemia are based on circulating blood lipid concentrations among which total cholesterol (TC) and triglycerides (TG)

  • There is evidence indicating that the newly developed Accutrend® Plus device (Roche Diagnostics GmbH, Mannheim, Germany) has been improved for in vivo diagnostic use [9]. Validation of this upgraded optical reflectance system is scarcely reported in the scientific literature. Since it remains unclear under which circumstances the use of this particular system is appropriate, the aims of this study were: 1) to determine the day-to-day reproducibility of the Accutrend® Plus device; 2) to assess the accuracy of the Accutrend® Plus system by comparing its results to those obtained by a reference laboratory method for monitoring lipid profile in adults; and 3) to assess the concordance between both methods for classifying subjects according to the National Cholesterol Education Program (NCEP)

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Summary

Introduction

The determination of lipid biomarkers by capillary sampling may be useful in the screening, diagnosis and/or personal management of hyperlipidemia and cardiovascular risk. It remains unclear whether the use of the Accutrend® Plus system is appropriate. Elevated concentrations of lipids in the blood have been associated with an increased risk of cardiovascular morbidity and mortality [1]. The classification of individuals based on lipid profile represents a general guidance for clinical decision making. In this context, portable devices such as the Accutrend system (Roche Diagnostics GmbH, Mannheim, Germany) offer a number of advantages over conventional laboratory machinery. In a number of studies, the Accutrend was found to be sufficiently accurate for clinical use; others concluded that the precision and the control range of the Biochemia Medica 2012;22(1):100

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