Siemens HCG IMMULITE 2000 Manual Del Usuario página 7

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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
7
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Immulite 2000 hcg

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