TRACEABILITY and UNCERTAINTY5 Roche/Hitachi – Preciset® Lp(a) Gen. 2

Cat. No. 05852641 190

Roche Diagnostics GmbH January 2013

Routine Method

Roche/cobas c systems

Reference Method Reference Material Selected Measurement

Procedure

Assigned Value Uncertainty 1 Unit

LPA2Lipoprotein (a)

immunoturbidimetric

Tina-Quant, Gen.2

SRM2B IFCC/WHO2,3,4

Manufacture’s selected measurement procedure

Level 1: 11.1

Level 2: 21.6

Level 3: 60.0

Level 4: 158

Level 5: 211

1.81

4.33

7.47

8.49

7.93

nmol/L

1 This uncertainty (expanded uncertainty; k = 2) was calculated in accordance with the “Guide to the expression of uncertainty in measurement” (GUM:1993). For the estimation of the single standard uncertainties normal distribution of the measurement results is assumed; the level of confidence of the expanded uncertainty is about 95% with the coverage factor k=2 (analogue to the 2sd of the standard uncertainty).

2 SRM = Standard Reference Material3 IFCC = International Federationof clinical chemistry and laboratory medicine4 WHO = World Health Organisation5 Unless otherwise noted, the assigned values and uncertainties are valid for Roche Hitachi Modular P provided that the method is available on that analyzer.