Materials Supplied - Siemens IMMULITE 2000 Manuel D'instructions

materials derived from human blood were
tested and found nonreactive for syphilis;
for antibodies to HIV 1 and 2; for hepatitis
B surface antigen; and for antibodies to
hepatitis C.
Chemiluminescent Substrate: Avoid
contamination and exposure to direct
sunlight. (See insert.)
Water: Use distilled or deionized water.

Materials Supplied

Components are a matched set. Labels on
the inside box are needed for the assay.
Androstenedione Bead Pack (L2AO12)
With barcode. 200 beads, coated with
polyclonal rabbit anti-androstenedione
antibody. Stable at 2–8°C until expiration
date.
L2KAO2: 1 pack
Androstenedione Reagent Wedge
(L2AOA2)
With barcode. 11.5 mL alkaline
phosphatase (bovine calf intestine)
conjugated to androstenedione in buffer.
Stable at 2–8°C until expiration date.
L2KAO2: 1 wedge
Before use, tear off the top of the label at
the perforations, without damaging the
barcode. Remove the foil seal from the top
of wedge; snap the sliding cover down into
the ramps on the reagent lid.
Androstenedione Adjustors
(LAOL, LAOH)
Two vials (Low and High), 2 mL each, of
androstenedione in a processed human
serum matrix. Stable at 2–8°C for 30 days
after opening, or for 6 months (aliquotted)
at –20°C.
L2KAO2: 1 set
Before making an adjustment, place the
appropriate Aliquot Labels (supplied with
the kit) on test tubes so that the barcodes
can be read by the on-board reader.
Kit Components
Supplied Separately
L2SUBM: Chemiluminescent Substrate
L2PWSM: Probe Wash
L2KPM: Probe Cleaning Kit
LRXT: Reaction Tubes (disposable)
IMMULITE 2000 Androstenedione (PIL2KAO-23, 2021-04)
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 sample pools with at least
two levels (low and high) of
androstenedione.
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
A reference range study was performed
on serum samples from 48 male and 58
female adult laboratory volunteers using
the IMMULITE 2000 Androstenedione
procedure.
Males: Median: 1.6 ng/mL (5.6 nmol/L)
Central 95% range: 0.6–3.1 ng/mL
(2.1–10.8 nmol/L)
Females: Median: 1.7 ng/mL (5.9 nmol/L)
Central 95% range: 0.3–3.3 ng/mL
(1.0–11.5 nmol/L)
Consider these limits as guidelines only.
Each laboratory should establish its own
reference ranges.
Limitations
The growing graafian follicle secretes
androstenedione, and a two-fold increase
in its production occurs near the midcycle.
Specimens drawn during this time may
3