Siemens IMMULITE 2000 Manuel D'instructions page 5

Alternate Sample Type: To assess the
effect of alternate sample types, blood
was collected from 26 volunteers into
plastic plain serum, heparinized, EDTA
and Becton Dickinson SST
tubes. Equal volumes of the matched
samples were spiked with various
concentrations of androstenedione, to
obtain values throughout the calibration
range of the assay, and then assayed by
the IMMULITE 2000 Androstenedione
procedure.
(Heparin) = 0.88 (Serum) – 0.15 ng/mL
r = 0.981
(SST) = 1.04 (Serum) – 0.10 ng/mL
r = 0.989
(EDTA) = All samples were >10 ng/mL.
Means:
3.83 ng/mL (Serum Plastic)
3.20 ng/mL (Heparin Plastic)
3.87 ng/mL (SST Plastic)
> 10 ng/mL (EDTA Plastic)
Neither EDTA nor heparinized plasma are
recommended for use.
Method Comparison 1: The assay was
compared to a commercially available
solid phase radioimmunoassay for
androstenedione (Kit A) on 78
endogenous patient samples.
(Concentration range: approximately
0.5 to 6 ng/mL. See graph 1.) By linear
regression:
(IML 2000) = 1.12 (Kit A) – 0.45 ng/mL
r = 0.950
Means:
1.67 ng/mL (IMMULITE 2000)
1.88 ng/mL (Kit A)
Method Comparison 2: The assay was
also compared to IMMULITE/IMMULITE
1000 Androstenedione on 334
endogenous and spiked samples.
(Concentration range: approximately
0.3 to 9.5 ng/mL. See graph 2.) By linear
regression:
(IML 2000) = 0.94 (IML) – 0.05 ng/mL
r = 0.992
Means:
2.49 ng/mL (IMMULITE 2000)
2.69 ng/mL (IMMULITE)
References
1) Abraham GE. Ovarian and adrenal
contribution to peripheral androgens during the
menstrual cycle. J Clin Endocrinol Metab
1974;39:340. 2) Baird DT. Ovarian steroid
secretion and metabolism in women. In: James
IMMULITE 2000 Androstenedione (PIL2KAO-23, 2021-04)
VHT, Serio M, Giusti G, editors. The Endocrine
Function of the Human Ovary. New York:
Academic Press, 1976: 125-33. 3) Fiet J et al.
Simultaneous radioimmunoassay of
androstenedione, dehydroepiandrosterone and
®
vacutainer
11β-hydroxyandrostenedione in plasma. Horm
Res 1980;13: 133-49. 4) Hummer L et al. An
easy and reliable radioimmunoassay of serum
androstenedione: age-related normal values in
252 females aged 2 to 70 years. Scand J Clin
Lab Invest 1983;43:301-6. 5) Judd HL, Yen
SSC. Serum androstenedione and testosterone
levels during the menstrual cycle. J Clin
Endocrinol Metab 1973;39:475. 6) Keenan BS et
al. Plasma androgens in congenital adrenal
hyperplasia; androstenedione concentration as
an index of adrenal androgen suppression. J
Lab Clin Med 1979;94:799-808. 7) Putz Z. A
selective radioimmunoassay of androstenedione
in plasma and saliva. J Clin Chem Clin Biochem
1982;20:761-4. 8) Raj S et al. Diagnostic value
of androgen measurements in polycystic ovary
syndrome. Obstet Gynecol 1978;52:169-71.
9) Redi B et al. Diagnostic strategy in
hyperandrogenic syndrome. Horm Res
1983;18:117-24. 10) Sciarra F. Diagnosis of
virilizing syndromes: endocrinological
parameters. In: Milinatti G et al, editors.
Androgenization in Women. New York: Raven
Press 1983;85-115. 11) Tourniaire J, Pugeat M.
Strategic approach of hyperandrogenism in
women. Horm Res 1983;18:125-34.
12) Vermeulen A. Androgen secretion by
adrenals and gonads. In: Mahesh V, Greenblatt
RB, editors. Hirsutism and Virilism. Boston: John
Wright PSG 1983;17-34. 13) Lejeune-Lenain C,
Van Cauter E, Desir D, et al. Control of circadian
and episodic variations of adrenal androgens
secretion in man. J Endocrinol Invest
1987;10:267-76. 14) Lupo C, Baldi L, Bonifazi
M, et al. Androgen levels following a football
match. Eur J Appl Physiol 1985;54:494-6.
15) Velardo A, Pantaleoni M, Valerio L, et al.
Influence of exercise on
dehydroepiandrosterone sulphate and d
androstenedione plasma levels in man. Exp Clin
Endocrinol 1991;97:99-101. 16) National
Committee for Clinical Laboratory Standards.
Procedures for the collection of diagnostic blood
specimens by venipuncture; approved standard.
4th ed. NCCLS Document H3-A4, Wayne, PA:
NCCLS, 1998. 17) 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. 18) 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. 19) Federal
Occupational Safety and Health Administration,
Bloodborne Pathogens Standard, 29 CFR
1910.1030.
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