Expected Values - Siemens IMMULITE 2000 Manual Del Usario

Thyroglobulin Reagent Wedge
(L2TYA2)
With barcode. 11.5 mL of ligand-labeled
anti-thyroglobulin murine monoclonal
antibody and alkaline phosphatase
(bovine calf intestine) conjugated to sheep
polyclonal anti-thyroglobulin antibody in
buffer, with preservative. Stable at 2–8°C
until expiration date.
L2KTY2: 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.
Thyroglobulin Adjustors (LTYL, LTYH)
Two vials (Low and High) of lyophilized
thyroglobulin in a nonhuman serum matrix,
with preservative. At least 30 minutes
before use: Reconstitute each vial with 4.0 mL distilled or deionized water. Mix by
gentle swirling or inversion until the
lyophilized material is fully dissolved.
Aliquot and freeze. Stable at –20°C for
2 months after reconstitution. L2KTY2: 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
Thyroglobulin Sample Diluent (L2TYZ):
For the on-board dilution of high samples.
25 mL of concentrated (ready-to-use)
thyroglobulin-free nonhuman serum
matrix. 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.
L2TYZ: 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
4
LTYCM: Tri-level, nonhuman
serum-based control module
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 2000 Systems Operator's
Manual.
See the IMMULITE Operator's Manual for
preparation, setup, dilutions, adjustment,
assay and quality control procedures.
Recommended Adjustment Interval:
2 weeks
Quality Control Samples: Use controls
or sample pools with at least two levels
(low and high) of thyroglobulin.

Expected Values

One hundred and ten serum samples from
apparently healthy subjects were tested
using the IMMULITE 2000 Thyroglobulin
procedure. The results ranged from 0.73
to 84 ng/mL, with a median of 11 ng/mL
and a 2.5th and 97.5th percentiles of 1.6
and 59.9 ng/mL, respectively.
Thirty serum samples from patients with
Hashimoto's disease were tested using
IMMULITE 2000 Thyroglobulin. The
thyroglobulin values ranged from
nondetectable to >300 ng/mL. Five of the
30 samples (17%) showed thyroglobulin
levels greater than 55 ng/mL.
Another 30 serum samples from patients
with Graves' disease were tested using
IMMULITE 2000 Thyroglobulin. The
thyroglobulin values ranged from
nondetectable to >300 ng/mL. Three of
the 30 samples (10%) manifested
thyroglobulin levels greater than
55 ng/mL.
In patients who have undergone
thyroidectomy, thyroglobulin
concentrations should theoretically
approach zero or approximate the
sensitivity of the thyroglobulins assay. Any
increase in the thyroglobulin level of such
patients should be further interpreted in
conjunction with other available diagnostic
test results and the patient's clinical
presentation.
IMMULITE 2000 Thyroglobulin (PIL2KTY-22, 2015-04-22)