Expected Values - Siemens IMMULITE 1000 Manual Del Usuario

Free T4 Adjustors (LFT4L, LFT4H)
Two vials (Low and High) of lyophilized
free T4 in processed human serum, with
preservative. Reconstitute each vial with
2.0 mL distilled or deionized water. Mix by
gentle swirling or inversion until the
lyophilized material is fully dissolved.
Stable at 2–8°C for 30 days after
reconstitution, or for 6 months (aliquotted)
at –20°C.
LKFT41: 1 set
Kit Components
Supplied Separately
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)
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 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: Follow government
regulations or accreditation requirements
for quality control frequency.
To monitor system performance and chart
trends, as a minimum requirement, quality
control materials with at least two levels
(low and high) of Free T4 should be
assayed on each day that samples are
analyzed. Quality control samples should
also be assayed when performing
adjustment. Treat all quality control
samples the same as patient samples.
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Siemens Healthcare Diagnostics
recommends the use of commercially
available quality control materials with at
least 2 levels (low and high). A satisfactory
level of performance is achieved when the
analyte values obtained are within the
Acceptable Control Range for the system,
or within an established range determined
by an appropriate internal laboratory
quality control scheme.
If the quality control results do not fall
within the Expected Values or within the
laboratory's established range, do not
report patient results. Take the following
actions:
•
Verify that the materials are not
expired.
•
Verify that required instrument
maintenance was performed.
•
Verify that the assay was performed
according to the instructions for use.
•
Re-run the assay with fresh quality
control samples.
•
If necessary, contact technical support
provider for assistance.

Expected Values

Based on its relationship to ADVIA
Centaur FrT assay (see Method
4
comparison), IMMULITE/IMMULITE 1000
Free T4 can be expected to have
essentially the same reference ranges:
FT4 Range
(ng/dL)
Euthyroid 0.89–1.76
Hypothyroid < 0.89
> 1.76
Hyperthyroid
Consider these limits as guidelines only.
Each laboratory should establish its own
reference ranges.
Limitations
The interpretation of free T4 results is
complicated by a variety of drugs which
can affect the binding of T4 to the thyroid
hormone-carrier proteins or interfere with
its metabolism to T3.
IMMULITE/IMMULITE 1000 Free T4 (PILKFT4-8, 2015-05-29)
FT4 Range
(pmol/L)
11.5–22.7
< 11.5
> 22.7
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