OPTi CCA-TS2 User Manual

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 uoride cause signicant 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 prociency 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 dif
ferent
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%

OPTi CCA-TS2 Specifications

General

Brand	OPTi
Model	CCA-TS2
Category	Measuring Instruments
Language	English