Siemens IMMULITE 2000 Manual De Instrucciones página 4

L2SUBM: Chemiluminescent Substrate
L2PWSM: Probe Wash
L2KPM: Probe Cleaning Kit
LRXT: Reaction Tubes (disposable)
L2ZT: 250 Sample Diluent Test Tubes
(16 × 100 mm)
L2ZC: 250 Sample Diluent Tube Caps
E2TC: Estradiol Control (single level)
Also Required
Distilled or deionized water; test tubes;
controls
Assay Procedure
Note that for optimal performance, it is
important to perform all routine
maintenance procedures as defined in the
IMMULITE 2000 Systems Operator's
Manual.
See the IMMULITE 2000 Systems
Operator's Manual for preparation, setup,
dilutions, adjustment, assay and quality
control procedures.
Recommended Adjustment Interval:
2 weeks
Quality Control Samples Follow
government regulations or accreditation
requirements for quality control frequency.
Use controls or serum pools with at least
two levels (low and high) of estradiol.
Siemens Healthcare Diagnostics
recommends the use of commercially
available quality control materials with at
least 2 levels (low and high). A satisfactory
level of performance is achieved when the
analyte values obtained are within the
Acceptable Control Range for the system,
or within an established range determined
by an appropriate internal laboratory
quality control scheme.
Expected Values
Based on its relationship to IMMULITE
Estradiol (see Method Comparison), the
assay can be expected to have essentially
the same reference ranges.
Reference ranges were generated using
IMMULITE Estradiol in a multi-national
study involving women in apparent good
health (age: 16–44 years), who
volunteered to have blood samples drawn,
on a daily basis, throughout one complete
ovulatory cycle. (See "Menstrual Cycle
Graph.")
4
Ovulatory Cycles
n*
Follicular Phase 54 (708)
Follicular Phase, 54 (108)
Days 2 to 3
Periovulatory, 54 (378)
 3 days
Luteal Phase 54 (604)
*Number of subjects (total number of results)
Ovulatory Cycles
n*
Follicular Phase 54 (708)
Follicular Phase, 54 (108)
Days 2 to 3
Periovulatory, 54 (378)
 3 days
Luteal Phase 54 (604)
*Number of subjects (total number of results)
Another study performed with IMMULITE
Estradiol yielded the following results.
Group n Mean Median
Adult males 50 30.5
Adult females:
Untreated 27 ND
Postmenopausal
Treated 27 ND
Postmenopausal
Oral 61 35.2
Contraceptives
ND: not detectable
Group n Mean Median
Adult males 50 112
Adult females:
27 ND
Untreated
Postmenopausal
Treated 27 ND
Postmenopausal
Oral 61 129
Contraceptives
ND: not detectable
Consider these limits as guidelines only.
Each laboratory should establish its own
reference ranges.
IMMULITE 2000 Estradiol (PIL2KE2-28, 2016-05-23)
Estradiol, pg/mL
Median Central 95%
42 ND–160
31 ND–84
133 34–400
93 27–246
Estradiol, pmol/L
Median Central 95%
154 ND–587
114 ND–308
489 124–1468
343 101–905
Estradiol, pg/mL
90%
Range
29.7 ND–56
ND ND–30
ND ND–93
24.5 ND–102
Estradiol, pmol/L
90%
Range
109 ND–206
ND ND–110
ND ND–341
90 ND–374