Siemens Coat-A-Count TSH IRMA Manual Del Usuario página 4

reconstitute the zero calibrator A with
6.0 mL distilled water, and the remaining
calibrators B through H with 3.0 mL
distilled water. Use volumetric pipets and
mix by gentle swirling. Stable at 2–8°C for
30 days after opening. The life of the
calibrators may be extended by freezing.
Aliquot, if necessary, to avoid repeated
freezing and thawing.
IKTS1: 1 set. IKTS5: 2 sets.
IKTSX: 3 sets.
The calibrators contain, respectively, 0,
0.15, 0.5, 1.5, 4, 15, 30 and 60
micro-International Units of TSH per
milliliter (µIU/mL) in terms of the World
Health Organization's Second
International Reference Preparations of
TSH for Immunoassay, number 80/558.
Intermediate calibration points may be
obtained by mixing calibrators in suitable
proportions.
Buffered Wash Solution Concentrate
(1TSBW*, 3TSBW
†
40 mL* (200 mL ) of a concentrated
buffered saline solution, with surfactants.
Using a transfer container, dilute each vial
of concentrate with 400 mL* (2,000 mL
distilled water, for a total volume of
440 mL* (2,200 mL
before use. Stable at 2–8°C for 6 months
after preparation.
IKTS1: 1 vial × 40 mL.
IKTS5: 1 vial × 200 mL.
IKTSX: 2 vials × 200 mL.
Materials Required But Not
Provided
Gamma counter — compatible with
standard 12x75 mm tubes
Rack shaker — set at approximately 200
strokes per minute
Reagent Preparation
Distilled or deionized water
Volumetric pipets: 3 mL and 6 mL
Graduated cylinder — for dispensing
†
400 mL (2,000 mL
Plastic storage container with lid — for
preparation and storage of Buffered Wash
Solution
Immunoassay
Micropipets: 100 µL and 200 µL
4
†
)
†
). Mix thoroughly
)
Dispenser — for delivering 2.0 mL of
Buffered Wash Solution
Foam decanting rack — available from
Siemens Healthcare Diagnostics (catalog
number: FDR).
4-cycle log-log graph paper
A tri-level, human serum-based
immunoassay control, containing TSH as
one of over 25 assayed constituents, is
available from Siemens Healthcare
Diagnostics (catalog number: CON6).
Specimen Collection
The patient need not be fasting, and no
special preparations are necessary.
Collect blood by venipuncture
tubes and separate the serum from the
cells. Since TSH is known to exhibit a
small circadian rhythm, the time of
collection should be noted.
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.
†
)
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. Coat-A-
Count TSH IRMA 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: 200 µL of serum per
tube
Storage: 2–8°C for 5 days, or 1 month at
20
–20°C.
Before assay, allow the samples to come
to room temperature (15–28°C) and mix
by gentle swirling or inversion. Aliquot, if
necessary, to avoid repeated thawing and
freezing. Do not attempt to thaw frozen
specimens by heating them in a
waterbath.
Immunometric Assay
Procedure
All components must be at room
temperature (15–28°C) before use.
Coat-A-Count TSH IRMA (PIIKTS-8, 2010-11-04)
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into plain