Performance Data - Siemens IMMULITE 2000 Manual De Instrucciones

Limitations
Pregnancy Samples: Exercise caution
when assaying pregnancy samples, since
estriol levels may be high enough to
interfere.
Neonatal Samples: The assay has not
been validated for use on neonatal
samples. Crossreacting steroids, including
estriol, circulating at high concentrations
during this period may cause spuriously
elevated results.
Heterophilic antibodies in human serum
can react with the immunoglobulins
included in the assay components causing
interference with in vitro immunoassays.
[See Boscato LM, Stuart MC. Heterophilic
antibodies: a problem for all
immunoassays. Clin Chem 1988:34:
27-33.] Samples from patients routinely
exposed to animals or animal serum
products can demonstrate this type of
interference potentially causing an
anomalous result. These reagents have
been formulated to minimize the risk of
interference; however, potential
interactions between rare sera and test
components can occur. For diagnostic
purposes, the results obtained from this
assay should always be used in
combination with the clinical examination,
patient medical history, and other findings.
The drug Fulvestrant (FASLODEX
cause falsely elevated estradiol results in
immunoassays. For patients being treated
with Fulvestrant, an alternate method that
is not expected to show cross reactivity to
Fulvestrant, such as Liquid
Chromatography-Mass Spectrometry
(LC-MS), should be used.
With the advent of new steroid based
medications (analogues) with similar
chemical structures to estradiol, there is
the possibility of cross-reactivity and
results inconsistent with the patients
clinical history. For diagnostic purposes,
the results should always be assessed in
conjunction with the patient's medical
history, clinical examination and other
findings. If the estradiol results are
inconsistent with clinical evidence,
additional testing is suggested to confirm
the result.
®
* FASLODEX is a registered trademark of
AstraZeneca
IMMULITE 2000 Estradiol (PIL2KE2-28, 2016-05-23)

Performance Data

See Tables and Graphs for data
representative of the assay's performance.
Results are expressed in pg/mL. (Unless
otherwise noted, all were generated on
serum samples collected in tubes without
gel barriers or clot-promoting additives.)
Conversion Factor:
pg/mL × 3.671  pmol/L
Reportable Range: 20 to 2000 pg/mL
(73–7342 pmol/L)
The assay is traceable to an internal
standard manufactured using qualified
materials and measurement procedures.
Analytical Sensitivity: 15 pg/mL
(55 pmol/L)
Precision: Samples were assayed in
duplicate over the course of 20 days,
two runs per day, for a total of 40 runs and
80 replicates. (See "Precision" table.)
Precision Profile: In a series of studies
involving 10 kit lots, samples spanning the
working range were assayed in 10 or 20
replicates per run. (See "Precision Profile"
graph.)
Linearity: Samples were assayed under
various dilutions. (See "Linearity" table for
representative data.)
Recovery: Samples spiked 1 to 19 with
®
)* may
three estradiol solutions (800, 1440 and
4020 pg/mL) were assayed. (See
"Recovery" table for representative data.)
Specificity: The antiserum was generated
with estradiol derivative at 6- position, and
is highly specific for estradiol. (See
"Specificity" table.)
Bilirubin: Presence of bilirubin in
concentrations up to 200 mg/L has no
effect on results, within the precision of the
assay.
Hemolysis: Presence of packed red blood
cells in concentrations up to 30 µL/mL has
no effect on results, within the precision of
the assay.
Lipemia: Presence of triglycerides in
concentrations up to 3000 mg/dL may
interfere with the assay. (See "Lipemia"
table.)
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