Siemens IMMULITE 2000 HCG Bedienungsanleitung Seite 7

Linearity (mIU/mL)
1 2
Dilution Observed Expected
5
1 16 in 16 204
8 in 16 100 102
4 in 16 50
2 in 16 24
1 in 16 12
2 16 in 16 552
8 in 16 273 276
4 in 16 134 138
2 in 16 68
1 in 16 33
3 16 in 16 1,144
8 in 16 556 572
4 in 16 267 286
2 in 16 140 143
1 in 16 70
4 16 in 16 2,088
8 in 16 1,020 1,044
4 in 16 503 522
2 in 16 240 261
1 in 16 119 131
Recovery (mIU/mL)
1 2
Solution Observed Expected
1 — 270 —
A 339 322
B 597 543
C 1,770 1,774
2 — 554 —
A 617 592
B 913 812
C 2,114 2,043
3 — 949 —
A 984 967
B 1,290 1,188
C 2,610 2,419
IMMULITE 2000 HCG (PIL2KCG-26, 2009-04-17)
Specificity
3 4
%O/E
— —
98%
FSH
51 98%
LH
26 92%
TSH
13 92%
ND: not detectable.
— —
99%
β-HCG
WHO
97%
75/551
69 99%
ng/mL
35 94%
42.2
— —
84.4
97%
169
93%
338
98%
*mIU HCG/mL × 0.10769 → ng HCG/mL
72 97% =
ng HCG/mL × 0.605 → ng β-HCG/mL
— —
Method Comparison
98%
96%
92%
91%
3 4
%O/E
—
105%
110%
100%
(IML 2000) = 1.0 (IML) – 21 mIU/mL
—
r = 0.994
104%
Expected Values During Pregnancy
112%
103%
—
102%
109%
108%
Amount Apparent %
Added Concentration Cross-
1 2
(ng/mL) (ng/mL) reactivity
26.8 ND ND
16.5 ND ND
860 ND ND
4
Apparent HCG
Concentration
β-HCG
HCG HCG Cross-
=
mIU/mL ng/mL* reactivity
ng/mL
825 88.8 53.7 127%
1,579 170 103 122%
2,789 300 182 108%
4,803 517 313 93%
3
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