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BUN-2 Operator’s Manual – OPTI CCA-TS
BUN/UREA
ANALYTES
Standard Reference Cassette (SRC) Limit Values
LOW NORMAL HIGH Units
BUN 5.6 ± 1.4 28.0 ± 1.4 70.0 ± 1.4 mg/dL
Urea 2 ± 0.5 10 ± 0.5 25 ± 0.5 mmol/L
Interferences
The OPTI CCA-TS BUN(urea) sensor has no interference from ammonia or ammonium ion present at
normal physiologic levels (below 100 µmol/L) nor at hyperammonemia (plasma levels of 300 µmol/L).
At extreme hyperammonemia (plasma levels of 3000µmol/L), the OPTI CCA-TS BUN(urea) sensor will
show an offset of +4.8 mg/dL BUN (1.7 mmol/L urea).
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. BUN(urea) values are
expressed in mg/dL and mmol/L, respectively.
Material mean S
wr (CV%)
S
dd (CV%)
S
T (CV%)
OPTI CHECK PLUS Level 1 (BUN mg/dL) 60.5 0.07 (0.1) 0.42 (0.7) 0.43 (0.7)
(aqueous control solution) (Urea mmol/L) 21.6 0.02 (0.1) 0.15 (0.7) 0.15 (0.7)
OPTI C HECK PLUS Level 2 (BUN mg/dL) 20.3 0.02 (0.1) 0.12 (0.6) 0.12 (0.6)
(aqueous control solution) (Urea mmol/L) 7.2 0.01 (0.1) 0.04 (0.6) 0.04 (0.6)
OPTI CHECK PLUS Level 3 (BUN mg/dL) 4.4 0.01 (0.2) 0.10 (2.2) 0.10 (2.2)
(aqueous control solution) (Urea mmol/L) 1.57 0.003 (0.2) 0.035 (2.2) 0.035 (2.2)
Serum (BUN mg/dL) 11.2 0.01 (0.1) 0.1 (0.8) 0.1 (0.8)
(Urea mmol/L) 4.0 0.004 (0.1) 0.04 (0.8) 0.04 (0.8)
All specific 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
3
Wherever possible, linearity for the OPTI CCA measurement has been established against reference
materials or methods. BUN(urea) linearity is established with N.I.S.T SRM 909b Human Serum.
Correlation
Slope Intercept Coefficient Sy.x Range n
1.0046 1.58 0.99919 1.75 16 - 86 6