Modular p800 analyser

After inclusion, participants visited the study center at baseline and after 26 weeks of treatment, after ≥ 6 h of fasting, for medical history assessment, standard physical examination, collection of venous blood samples and MRI. All blood samples were centrifuged and stored at − 80 °C until analysis. Plasma total cholesterol, HDL-cholesterol and triglyceride concentrations were measured on a Modular P800 analyser (Roche Diagnostics, Mannheim, Germany). LDL-cholesterol was calculated according to the Friedewald formula [26 (link)]. HbA1c was assessed with ion-exchange high-performance liquid chromatography (HPLC; Tosoh G8, Sysmex Nederland B.V., Etten-Leur, the Netherlands). Body composition and lean body mass was assessed using bioelectrical impedance analysis (BIA; Bodystat 1500, Bodystart Ltd., Douglas, UK).

At study entry and at 26 weeks, blood examinations were performed after participants had fasted for at least 6 h. HbA_1c was measured using boronate affinity high-performance liquid chromatography (Primus Ultra; Siemens Healthcare Diagnostics, Breda, the Netherlands) throughout the first part of the study, and changed to measurement using ion-exchange high-performance liquid chromatography (Tosoh G8; Sysmex Nederland, Etten-Leur, the Netherlands) for subsequent measurements. HbA_1c values assessed by the boronate affinity method were corrected on the basis of the correlation coefficient derived from a validation experiment that used data of 196 samples measured on both analysers. All other blood samples were processed and analysed as described previously [20 (link)]. Adiponectin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and γ-glutamyl transferase (GGT) concentrations were measured with a Modular P800 analyser (Roche Diagnostics, Mannheim, Germany). Serum NEFA were measured using the NEFA C kit (Wako Diagnostics, INstruchemie, Delfzijl, the Netherlands).

The analytes studied were: glucose (Glc), total proteins (TP), urea, creatinine (CREA), cystatin C, total bilirubin (BT), total cholesterol, HDL, LDL, Tg, uric acid (UA), high-sensitivity C-reactive protein (hsCRP), gamma-glutamyltransferase (GGT), aspartate-aminotransferase (AST), alanine-aminotransferase (ALT) and lactate-dehydrogenase (LD).
Biochemical determinations were performed by the Vitros® 4600 autoanalyser (Ortho Clinical Diagnostics, New Jersey, USA) with proprietary reagents and calibrators. Internal and external quality controls were included as part of the standard procedure. Measurements of the analytes cystatin C, hsCRP and LDL were performed using a Modular P800® analyser (Roche Diagnostics, Mannheim, Germany) following the same quality specifications. In both cases, determinations were made at the same time, which ensured the use of the same reagent lot, thus avoiding lot-to-lot variability. The analytical coefficient of variation (CV_A) for each analyte was obtained using third party control material (BIORAD, Irvine, USA). Table 2 lists the analytes studied and the methods followed for their determination.