BUN-2
Operator’s Manual – OPTI CCA-TS2
BUN/UREA
ANALYTES
Standard Reference Cassette (SRC) Limit Values
LOW
NORMAL
HIGH
Units
5.6 ± 1.4
28.0 ± 1.4
70.0 ± 1.4
mg/dL
2.0 ± 0.5
10.0 ± 0.5
25.0 ± 0.5
mmol/L
Interferences
The OPTI CCA 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 BUN(urea) sensor will
show an offset of +4.8 mg/dL BUN (1.7 mmol/L urea). This testing was done on the OPTI CCA platform,
with a standard OPTI style BUN(urea) sensor. No changes were made to the sensor or the measurement
principle, so the interference of the OPTI CCA-TS2 is equivalent to the OPTI CCA.
Heparin salts are the only acceptable anticoagulants. Other anticoagulants such as citrate, EDTA, oxalate,
and fluoride cause significant interferences to the BUN(urea) sensor.
Only clear, uncolored quality control materials, such as OPTI CHECK PLUS brand aqueous controls
should be used with the OPTI CCA-TS2 system. Colored materials, including proficiency testing
materials, may interfere with the BUN(urea) measurement, or fail to be properly aspirated.
Reproducibility
Controls
Within run precision (S
wr
) and Total Precision (S
T
), were determined from 2 runs per day with 2 replicates
per run over a period of 10 days following the CLSI guideline EP5-A2. Typical results for 3 different
control levels are shown below.
BUN (mg/dL)
OPTI Check Level 1
OPTI Check Level 2
OPTI Check Level 3
Days Run
10
10
10
Total Average
74.1
19.3
5.9
Within Run St. Dev. (S
wr
)
3.0
0.6
0.1
Within Run % CV
4.0%
3.2%
1.9%
Total Precision St. Dev. (S
T
)
3.5
0.7
0.2
Total % CV
4.7%
3.7%
3.2%
Содержание CCA-TS2
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