Performance characteristics Measuring range “The test has been developed to determine LDL-Cholesterol Concentration until 400 mg/6L, When values exceed this ange samples should be diuted 144 with NaCl-Solution (8 g/L) and the result multiplied by 5, Specificity /Interferences No interference was observed by bilirubin up to 30 mg/dl. ‘and hemoglobin up to 800 mg/dL. Limit of detection ‘The lower limit of detection Is 2 ma/Ah. Precision intra-assay | Mean 35 wr n= 20, Ima/dt)_| _tmgydty [1 [Sample 20, 0.81 a | Sample 2 57 247 43 Sample 3 aa 139 10 Trter-assay | Mean 30 VK n= 10 [ma/st) | tma/suy 6) ‘sample T 62 1.90 3.0) Sample 2 Bt 280 21 Sample 3 283 2.09 o7 Method comparison 'A comparison of LDL-Cholesterol values obtained with the DiaSys LDL precipitant (y) with the Friedewald calculation (x) using 49 samples gave following results: y= 1121 x~ 9.62 mg/dl; r= 0.947 Reference range [4] LDL cholestero! Desirable £130 mg/dL (3.4 mmol/L) Borderline high risk 130 -160 mg/di. (3.4 ~ 4.1 mmol/L) High risk > 160 mg/dl. (> 4.1 mmol/L) Each laboratory should check if the reference ranges are transferable to its own patient population and determine own reference ranges if necessary. Clinical Interpretation (2) Epidemiological studies have observed that low HOL- Cholesterol concentrations < 39 mg/dL (0.9 mmol/L) in men and < 43 mg/dl. (1.0 mmol/L) in women) especially if associated with fasting triglycerides > 180 mg/dl. (2 mmol/L), predict @ high risk of coronary heart disease The European Task Force on Coronary Prevention recommends to lower TC concentration to less than $90 mg/dl (5.0 mmol/L) and LDL-cholesterol to less than 115 mg/at (3.0 mmol/L}. LDL Preciptant- Page 2 Literature 1 Rifai N, Bachorik PS, Albers 3- Lipids, lipoproteins and Spolipoproteins. In: Burtis CA, Ashwood ER, editors Tletz Textbook "of Clinical’ Chemistry. 3 ed. Philadelphia: W.8 Saunders Company; 1999. p. 809- 61, Recommendation of the Second Joint Task Force of European and other Societies on Coronary Prevention Prevention of coronary heart disease in clinical practice, Gur Heart } 1998;19: 1434-503. Copes-Virela MF, Stone Py Elis S, Colwell 3A. Cholesterol determination in high-density lipoproteins ‘separated by. three. different methods. Clin Chem 1977;23,982-4. Schaefer £), McNamara 3. Overview of the diagnosis tnd treatment of lipid disorders. In: Rifai N, Warnick GR, Dominezak MH, eds. Handbook of lipoprotein testing. Washington: RACC Press;1997.p.25-48. Guder WG, Zawta B et al, The Quality of Diagnostic Samples. 1" ed. Darmstadt: GIT Verlag; 200. e223. Manufacturer Diasys Diagnostic Systems GmbH Alte Strasse 9 65558 Holzhelm Germany 1844 4330 10 02 00 sanwary 2009/2