Technical Assistance - Siemens IMMULITE 1000 Manual Del Usuario

Means:
1.44 ng/dL (Serum)
1.44 ng/dL (Heparin)
1.47 ng/dL (SST)
Method Comparison. The
IMMULITE/IMMULITE 1000 Free T4
assay was compared to ADVIA Centaur
FrT on 284 patient samples.
4
(Concentration range: approximately
0.3 to 5.4 ng/dL. See graph.) By linear
regression:
(IML) = 1.03 (Centaur) – 0.032 ng/dL
r = 0.975
Means:
1.44 ng/dL (IMMULITE)
1.37 ng/dL (Centaur)
References
1. Hay ID, Bayer MF, et al. American Thyroid
Association assessment of current free thyroid
hormone and thyrotropin measurements and
guidelines for future clinical assays. Clin Chem
1991;37:2002-8. 2. Lindstedt G, et al. Clinical
use of laboratory thyroid tests and
investigations. JIFCC 1994;6:136-41. 3. Mandel
SJ, Brent GA, Larsen PR. Levothyroxine therapy
in patients with thyroid disease. Ann Intern Med
1993;119:492-502. 4. Singer PA, Cooper DS,
et al. Treatment guidelines for patients with
hyperthyroidism and hypothyroidism. JAMA
1995;273:808-12. 5. Witherspoon LR, El Shami
AS, et al. Chemically blocked analog assays for
free thyronines. Clin Chem 1988;34:9–16 and
17–23. 6. Wosilait WD. A theoretical analysis of
the distribution of thyroxine among sites on
thyroid binding globulin, thyroid binding
prealbumin and serum albumin. Res Commun
Chem Pathol Pharmacol 1977;16:541–8.
7. CLSI. Protocols for the Determination of
Limits of Detection and Limits of Quantitation;
Approved Guideline. CLSI document EP17-A
Vol 24 (No 34). CLSI, 940 West Valley Road,
Suite 1400, Wayne, Pennsylvania 19087-1898,
USA, 2004. 8. Evaluation of Precision
Performance of Quantitative Measurement
Methods; Approved Guideline – Second Edition.
CLSI document EP5-A2. CLSI, 940 West Valley
Road, Suite 1400, Wayne, Pennsylvania 19087-
1898, USA, 2004. 9. Centers for Disease
Control. Update: Universal precautions for
prevention of transmission of human
immunodeficiency virus, hepatitis B virus and
other bloodborne pathogens in healthcare
settings. MMWR, 1988;37:377–82, 387–8.
6
10. Clinical and Laboratory Standards Institute
(formerly NCCLS). Protection of Laboratory
Workers From Occupationally Acquired
Infections; Approved Guideline - Third Edition.
Wayne, PA: Clinical and Laboratory Standards
Institute; 2005. NCCLS Document M29-A3.
11. Federal Occupational Safety and Health
Administration, Bloodborne Pathogens
Standard, 29 CFR 1910.1030.

Technical Assistance

In the United States, contact
Siemens Healthcare Diagnostics
Technical Services department.
Tel: 877.229.3711. Outside the United
States, contact your National Distributor.
www.siemens.com/diagnostics
The Quality System of Siemens Healthcare
Diagnostics Products Ltd. is certified to
ISO 13485:2003.
Tables and Graphs
Precision (ng/dL)
Within-Run
3 4
Mean SD
1 0.47 0.046
2 0.80 0.059
3 1.09 0.059
4 1.43 0.064
5 2.77 0.117
6 4.83 0.200
IMMULITE/IMMULITE 1000 Free T4 (PILKFT4-8, 2015-05-29)
1 2
Total
5
CV SD CV
9.8% 0.057 12.1%
7.4% 0.065 8.1%
5.4% 0.072 6.6%
4.5% 0.078 5.5%
4.2% 0.143 5.2%
4.1% 0.249 5.2%