Warnings And Precautions; Materials Supplied - Siemens Immulite Homocysteine 2000 User Manual

synthesis of HCY will take place in red
blood cells after sampling. Samples
should be stored on ice between the
time of sampling and centrifugation.
Note that storage on ice makes the use of
serum samples particularly difficult.
The use of an ultracentrifuge is
recommended to clear lipemic samples.
Hemolyzed samples may indicate
mistreatment of a specimen before receipt
by the laboratory; hence the results should
be interpreted with caution.
Centrifuging serum samples before a
complete clot forms may result in the
presence of fibrin. To prevent erroneous
results due to the presence of fibrin,
ensure that complete clot formation has
taken place prior to centrifugation of
samples. Some samples, particularly
those from patients receiving
anticoagulant therapy, may require
increased clotting time.
Blood collection tubes from different
manufacturers may yield differing values,
depending on materials and additives,
including gel or physical barriers, clot
activators and/or anticoagulants.
IMMULITE 2000 Homocysteine has not
been tested with all possible variations of
tube types. Consult the section on
Alternate Sample Types for details on
tubes that have been tested.
Volume Required: 15 µL plasma or
serum.
Storage: 14 days at 2–8°C, or 6 months
at –20°C.

Warnings and Precautions

For in vitro diagnostic use.
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
IMMULITE 2000 Homocysteine (PIL2KHO-14, 2007-11-20)
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. Labels on
the inside box are needed for the assay.
Homocysteine Bead Pack (L2HO12)
With barcode. 200 beads, coated with
S-adenosyl-L-homocysteine (SAH). Stable
at 2–8°C until the expiration date.
L2KHO2: 1 pack.
Homocysteine Reagent Wedge
(L2HOA2)
With barcode. One wedge, containing 3
reagents: 15.5 mL bovine S-adenosyl-L-
homocysteine hydrolase in buffer, with
preservative. 18.5 mL dithiothreitol (DTT)
in buffer. 11.5 mL alkaline phosphatase
(bovine calf intestine) conjugated to
murine monoclonal anti-SAH in buffer.
Stable at 2–8°C until expiration date.
L2KHO2: 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.
Homocysteine Adjustors (LHOL, LHOH)
Two amber vials (Low and High), 2.0 mL
each, of synthetically-derived S-adenosyl-
L-homocysteine (SAH) in a protein/buffer
matrix. Stable at 2–8°C for 30 days after
opening, or for 6 months (aliquotted) at
–20°C.
L2KHO2: 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
Homocysteine Sample Diluent (L2HOZ)
For the on-board dilution of high samples.
25 mL of concentrated (ready-to-use)
homocysteine-free protein/buffer matrix.
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