Reproducibility, accuracy and concordance of Accutrend Plus for measuring circulating lipid concentration in adults

Biochem Med (Zagreb). 2012;22(1):100-8. doi: 10.11613/bm.2012.011.

Abstract

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. This study aimed to assess its reproducibility, accuracy and concordance for blood lipid profiling in adults.

Materials and methods: 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.

Results: 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).

Conclusions: 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.

Uvod: Određivanje lipida uzorkovanjem kapilarne krvi može se primijeniti pri probiru, dijagnozi i/ili osobnom praćenju hiperlipidemije i kardiovaskularnog rizika. Pitanje je li sustav Accutrend® Plus primjeren za taj zadatak ostaje još nerazjašnjeno. Ovim istraživanjem želimo procijeniti ponovljivost, točnost i podudarnost sustava pri određivanju lipidnog statusa krvi kod odraslih osoba.

Materijali i metode: Rezultati određivanja koncentracije ukupnog kolesterola (engl. total cholesterol, TC) i triglicerida (TG) natašte iz kapilarne krvi na sustavu Accutrend® Plus uspoređeni su s rezultatima analognih pretraga iz venske krvi dobivenih referentnim laboratorijskim metodama kod 61 odrasle osobe (27 muškaraca i 34 žena, median dobi 33,0 godine). Dodatno uzorkovanje kapilarne krvi provedeno je dva dana za redom vodeći računa o unosu makronutrijenata.

Rezultat:: Ponovljivost iz dana u dan na sustavu Accutrend® Plus bila je visoka za TC (ICC = 0,85, P < 0,001), no umjerena za TG (ICC = 0,68, P < 0,001). Za oba parametra TC i TG dobivene su jake korelacije (r ≥ 0,80, P < 0,001) s referentnom metodom. Granice podudaranja srednjih statističkih razlika bile su: 0,26 mmol/L (−0,95, 1,47) za TC, i −0,16 mmol/L (−1,29, 0,98) za TG. Podudarnost za klasifikaciju ispitanika prema smjernicama Nacionalnog programa za edukaciju o kolesterolu (engl. National Cholesterol Education Program, NCEP) bila je statistički značajna (P < 0,001) sa značajnom podudarnošću za TC (κw = 0,67) te umjerenom za TG (κw=0,50).

Zaključak:: Ponovljivost iz dana u dan na uređaju Accutrend® Plus za TC i TG nije optimalna i nedostaje joj točnosti u usporedbi s referentnom laboratorijskom metodom. Podudarnost između te dvije metode za klasifikaciju ispitanika prema smjernicama NCEP je neodgovarajuća. Uređaj Accutrend® Plus se ne bi trebao primjenjivati kao potpuna zamjena standardnih laboratorijskih metoda u dijagnostici hiperlipidemije.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Blood Chemical Analysis / instrumentation*
  • Cholesterol / blood*
  • Female
  • Humans
  • Lipids / blood*
  • Male
  • Middle Aged
  • Reproducibility of Results
  • Triglycerides / blood*
  • Young Adult

Substances

  • Lipids
  • Triglycerides
  • Cholesterol