5. Performance characteristics
ABL800 FLEX Reference Manual
Performance test results - bilirubin,
Continued
Performance
test results for
bilirubin
(continued)
Micromodes: 95
µ
L (syringe and capillary), 55
µ
L (capillary) and 35
µ
L
(capillary):
ctBil
(
µ
mol/L)
ctHb
(g/dL)
sO
2
(%)
S
0
S
D
S
T
S
I
S
ABL
S
X
≈
0
Plasma 1.1
1.4
2.2 0.4 2.3 2.9
≈
0
10 100
1.9
3.1
4.0 3.2 5.1 6.3
≈
0
15 100
2.3
2.9
7.4 5.5 9.2 9.9
≈
0
20 100 3.4
2.6
10.9 13.0 17.0 17.5
≈
200
Plasma 2.0
1.7
2.9 3.9 6.8 7.3
≈
200
10 100
3.7
3.9
6.0 5.6 9.6
11.0
≈
200
15 100
4.4
4.2
9.3 7.9
13.2
14.6
≈
200
20 100 5.6
5.9
13.0 16.3 21.6 23.1
≈
400
Plasma 3.5
2.5
4.3 7.8 10.6
11.4
≈
400
10 100
6.7
5.7
9.9 9.6
15.2
17.6
≈
400
15 100 7.9
6.7
13.5 12.5 19.7 22.3
≈
400
20 100 9.5
10.9
17.8 23.6 30.7 33.9
Notes:
a, b, c
NOTES:
a.
Adult/fetal blood, pH = 7.4
±
0.1, normal MCHC and albumin variation,
Spiked with unconjugated bilirubin.
b.
c
tBil specification at level 200
µ
mol/L is interpolated from the measured
specifications at 0 and 400
µ
mol/L.
c.
The performance specifications apply to measurements performed using
CLINITUBES with clot catchers and mixing wire from Radiometer.
References
1. Fraser CG. The application of theoretical goals based on biological variation
data in proficiency testing. Arch Pathol Lab Med 1988; 112: 402-15.
2. Ehrmeyer SS, Laessig RH, Leinweber JE, Oryall JJ. 1990 Medicare/CLIA
final rules for proficiency testing: minimum intralaboratory performance
characteristics (CV and bias) needed to pass. Clin Chem 1990; 36, 10: 1736-
40.
Continued on next page
5-44
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