Siemens IMMULITE 2000 Mode D'emploi page 4

GH Adjustors (LGHL, LGHH)
Two vials (Low and High) containing
lyophilized hGH in a nonhuman serum,
with preservative. Reconstitute each vial
with 3.0 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.
L2KGRH2: 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
Multi-Diluent 2 (L2M2Z, L2M2Z4)
For the on-board dilution of high samples.
One vial of concentrated (ready-to-use),
nonhuman protein/buffer matrix, with
preservative. Stable at 2–8°C for 30 days
after opening, or for 6 months (aliquotted)
at –20°C.
L2M2Z: 25 mL L2M2Z4: 55 mL
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.
L2M2Z: 3 labels L2M2Z4: 5 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
Also Required
Distilled or deionized water; test tubes;
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 2000 Systems
Operator's Manual for preparation, setup,
dilutions, adjustment, assay and quality
control procedures.
4
Recommended Adjustment Interval:
2 weeks
Quality Control Samples: Follow
government regulations or accreditation
requirements for quality control frequency.
Use controls or serum pools with at least
two levels (low and high) of human growth
hormone.
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.
Expected Values
A study performed on 67 healthy adult
males and 149 healthy adult females
yielded the following reference intervals:
Males: Up to 3 ng/mL
Females: Up to 8 ng/mL
Secretion of growth hormone by the
pituitary gland is episodic and pulsatile,
and transient levels up to 40 ng/mL have
been observed in healthy subjects.
Because serum levels are rather low
between pulses in healthy individuals,
immunoassays with sufficient sensitivity
are necessary to distinguish patients with
abnormally low values from healthy
subjects who have values that happen to
fall in the low-normal range. Thus, basal or
random levels of hGH provide little
diagnostic information. In some
individuals, spontaneous growth hormone
secretion is better monitored by using a
continuous withdrawal pump, or by
drawing specimens for hGH assay every
20 to 30 minutes over a 12-to-24-hour
period. A number of provocative tests
designed to stimulate or suppress release
are also used to assess growth hormone
secretion; the definition of abnormal
responses varies with the laboratory.
Consider these limits as guidelines only.
Each laboratory should establish its own
reference ranges.
IMMULITE 2000 Growth Hormone (hGH) (PIL2KGRH-11, 2018-03-15)
1