CAUTION: This device contains material
of animal origin and should be handled as
a potential carrier and transmitter of
disease.
Reagents: Store at 2–8°C. Dispose of in
accordance with applicable laws.
Follow universal precautions, and handle
all components as if capable of
transmitting infectious agents. Source
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.
Sodium azide, at concentrations less than
0.1 g/dL, has been added as a
preservative. On disposal, flush with large
volumes of water to prevent the buildup of
potentially explosive metal azides in lead
and copper plumbing.
Chemiluminescent Substrate: Avoid
contamination and exposure to direct
sunlight. (See insert.)
Water: Use distilled or deionized water.
Materials Supplied
Components are a matched set. The
barcode labels are needed for the assay.
Cortisol Test Units (LCO1)
Each barcode-labeled unit contains one
bead coated with polyclonal rabbit
anti-cortisol antibody. Stable at 2–8°C until
expiration date.
LKCO1: 100 units
Allow the Test Unit bags to come to room
temperature before opening. Open by
cutting along the top edge, leaving the
ziplock ridge intact. Reseal the bags to
protect from moisture.
Cortisol Reagent Wedge (LCO2)
With barcode. 7.5 mL alkaline
phosphatase (bovine calf intestine)
conjugated to cortisol in buffer, with
preservative. Store capped and
refrigerated: stable at 2–8°C until
expiration date. Recommended usage is
within 30 days after opening when stored
as indicated.
LKCO1: 1 wedge
IMMULITE/IMMULITE 1000 Cortisol (PILKCO-16, 2016-02-08)
Cortisol Adjustors (LCOL, LCOH)
Two vials (Low and High), 3 mL each, of
cortisol in processed human serum, with
preservative. Stable at 2–8°C for 30 days
after opening, or for 6 months (aliquotted)
at –20°C.
LKCO1: 1 set
Kit Components
Supplied Separately
Cortisol Sample Diluent (LCOZ)
For the dilution of patient samples. One
vial containing 25 mL of processed
cortisol-free human serum, with
preservative. Stable at 2–8°C for 30 days
after opening, or for 6 months (aliquotted)
at –20°C.
LSUBX: Chemiluminescent Substrate
LPWS2: Probe Wash Module
LKPM: Probe Cleaning Kit
LCHx-y: Sample Cup Holders (barcoded)
LSCP: Sample Cups (disposable)
LSCC: Sample Cup Caps (optional)
Also Required
Sample transfer pipets, distilled or
deionized water, controls
Assay Procedure
Note that for optimal performance, it is
important to perform all routine
maintenance procedures as defined in the
IMMULITE or IMMULITE 1000 Operator's
Manual.
See the IMMULITE or IMMULITE 1000
Operator's Manual for preparation, setup,
dilutions, adjustment, assay and quality
control procedures.
Visually inspect each Test Unit for the
presence of a bead before loading it onto
the system.
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 cortisol.
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
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