Expected Values - Siemens IMMULITE 1000 Thyroglobulin Manual Del Usuario

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.
Thyroglobulin Reagent Wedge (LTY2)
With barcode. 7.5 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. Store capped
and refrigerated: stable at 2–8°C until
expiration date. Recommended usage is
within 30 days after opening when stored
as indicated.
LKTY1: 1 wedge
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.
LKTY1: 1 set
Kit Components
Supplied Separately
Thyroglobulin Sample Diluent (LTYZ)
For the manual dilution of patient samples.
One vial 25 mL containing a thyroglobulin-
free nonhuman serum matrix, 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)
LTYCM: Tri-level, nonhuman serum-
based control module.
LTYRM: IMMULITE Thyroglobulin
Recovery Sample. An elevated
concentration of thyroglobulin in a
nonhuman serum matrix, with
preservative.
Also Required
Sample transfer pipets, distilled or
deionized water, controls.
4
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: 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 Thyroglobulin
procedure. The results ranged from 0.83
to 68 ng/mL, with a median of 10.2 ng/mL
and a 2.5th and 97.5th percentiles of
1.7 and 55.6 ng/mL, respectively.
Thirty serum samples from patients with
Hashimoto's disease were tested using
IMMULITE Thyroglobulin. The
thyroglobulin values ranged from
nondetectable to 268 ng/mL. Four of the
30 samples (13%) showed thyroglobulin
levels greater than 55 ng/mL.
Another 30 serum samples from patients
with Graves' disease were tested using
IMMULITE 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/IMMULITE 1000 Thyroglobulin (PILKTY-24, 2015-04-30)