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 TBG 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: 20 µL serum.
Storage: 2 days at 2–8°C, or
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1 month 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
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.
TBG Bead Pack (L2TB12)
With barcode. 200 beads, coated with
monoclonal murine anti-TBG. Stable at
2–8°C until expiration date.
L2KTB2: 1 pack.
IMMULITE 2000 TBG (PIL2KTB-18, 2010-07-07)
TBG Reagent Wedge (L2TBA2)
With barcode. 11.5 mL alkaline
phosphatase (bovine calf intestine)
conjugated to human TBG in buffer, with
preservative. Stable at 2–8°C until
expiration date.
L2KTB2: 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.
TBG Adjustors (LTBL, LTBH)
Two vials (Low and High), 4 mL each, of
human TBG in buffer, with preservative.
Stable at 2–8°C for 30 days after opening,
or for 6 months (aliquotted) at –20°C.
L2KTB2: 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
TBG Sample Diluent (L2TBZ)
For the on-board dilution of high samples.
25 mL of concentrated (ready-to-use)
TBG-free buffer. Storage: 30 days (after
opening) at 2–8°C or 6 months
(aliquotted) at –20°C.
Barcode labels are provided for use with
the diluent. Before use, place an
appropriate label on a 16 × 100 mm test
tube, so that the barcodes can be read by
the on-board reader.
L2TBZ: 3 labels
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
LTBCM: TBG Contol Module (bi-level
control containing human TBG)
Also Required
Distilled or deionized water; test tubes;
controls.
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