Technical Assistance - Siemens Coat-A-Count TSH IRMA Manual Del Usuario

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18) Klee GG, Hay ID. Assessment of sensitive
tyrotropin assays for an expanded role in thyroid
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performance and clinical utility. J Clin Endocrinol
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diagnostic blood specimens by venipuncture;
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H3-A4, Wayne, PA: NCCLS, 1998. 22) Baloch
Z, Carayon P, Conte-Devolx B, Demers LM,
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disease. Thyroid 2003 Jan;13(1):3-126. Also
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Technical Assistance

In the United States, contact Siemens
Healthcare Diagnostics Technical
Services department. Tel: 877.229.3711.
To place an order: Tel: 800.255.3232.
Outside the United States, contact your
National Distributor.
www.siemens.com/diagnostics
The Quality System of Siemens Healthcare
Diagnostics Inc. is certified to ISO 13485:2003.
Coat-A-Count TSH IRMA (PIIKTS-8, 2010-11-04)
Tables and Graphs
Example Run
Duplicate Average
1 2
Tube CPM CPM
188,551
7
T 189,633
190,715
119
8
A (NSB) 117
114
317
B 337
356
897
C 871
845
2,317
D 2,312
2,306
5,753
E 5,727
5,701
17,703
F 17,641 17,524
17,579
29,792
G 29,559 29,442
29,326
H 44,212
44,563 44,446 100%
9
("MB") 44,913
10
Unknowns
457
X1 436
514
11,808
X2 11,847 11,730
11,885
28,087
X3 28,132 28,015
28,177
Quality Control Parameters:
7
T = 189,633 cpm
8
%NSB = 0.06%
9
%MB = 24%
Intraassay Precision (µIU/mL)
1
Mean
1 0.25
2 0.36
3 1.84
4 3.83
5 10.3
6 17.6
7 29.2
Net Percent TSH
3 4 5
CPM Bound µIU/mL
0 —
0
220
0.5% 0.15
754
1.7% 0.5
2,195
4.9% 1.5
5,610
13% 4.0
39% 15
66% 30
60
319 0.7% 0.22
26% 9.7
63% 28
11
2 3
SD CV
0.01 4.5%
0.02 5.8%
0.08 4.4%
0.09 2.5%
0.22 2.1%
0.33 1.9%
0.67 2.3%
6
9