OPTIMedical OPTI CCA-TS - Page 221

Operator’s Manual – OPTI CCA-TS Glu-3
ANALYTES GLUCOSE
Reproducibility
Typical Within-Run (Swr), Between-Day (Sdd) and Total (ST) Precision is determined from 1 run per
day with 2 replicates per run for 20 days on each of two OPTI CCA instruments. Glucose values are
expressed in mg/dL and mmol/L.
Material mean Swr (CV%) Sdd (CV%) ST (CV%)
OPTI CHECK PLUS Level 1 (mg/dL) 44.9 0.28 (0.6) 1.38 (3.1) 1.42 (3.2)
(aqueous control solution) (mmol/L) 2.49 0.02 (0.6) 0.08 (3.1) 0.08 (3.2)
OPTI CHECK PLUS Level 2 (mg/dL) 102.8 0.38 (0.4) 2.87 (2.8) 2.90 (2.8)
(aqueous control solution)
(mmol/L) 5.70 0.02 (0.4) 0.16 (2.8) 0.16 (2.8)
OPTI CHECK PLUS Level 3 (mg/dL) 252.4 1.7 (0.7) 12.4 (4.9) 12.5 (5.0)
(aqueous control solution) (
mmol/L) 14.01 0.09 (0.7) 0.69 (4.9) 0.69 (5.0)
Serum (mg/dL) 71.9 0.3 (0.4) 1.7 (2.4) 1.8 (2.5)
(mmol/L) 3.94 0.02 (0.4) 0.09 (2.4) 0.10 (2.5)
All specic performance characteristics tests were run with default instrument calibration and after
normal recommended equipment quality control checks were performed (see Operator’s Manual).
Specimens at each level were analyzed in replicates of two for 20 days. The within-run and
between-day standard deviations were calculated by the analysis of variance method.
Linearity
2
Wherever possible, linearity for the OPTI CCA measurement has been established against reference
materials or methods. Glucose linearity is established by measurement of gravimetrically prepared,
N.I.S.T. traceable aqueous standard solutions (Glucose
ST
). Glucose linearity in serum is by measurement
of N.I.S.T. Standard Reference Material 965 Glucose in Frozen Human Serum (Glucose
NIST
).
Correlation
 Slope Intercept Coefcient Sy.x Range n
Glucose
ST
mg/dL 0.9874 3.26 0.9959 7.57 30 - 400 126
Glucose
ST
mmol/L 0.9874 0.181 0.9959 0.420 1.6 - 23.0 126
Glucose
NIST
mg/dL 1.0256 -7.79 0.9912 8.13 97 - 306 36
Glucose
NIST
mmol/L 1.0256 -0.432 0.9912 0.451 5.4 - 17 36