Warnings And Precautions; Intended Use - Diesse CHORUS PRL Instructions Pour L'utilisation

INSTRUCTIONS FOR USE
CHORUS
For the quantitative determination of Prolactin
hormone (PRL)
For In Vitro Diagnostic Use Only
1.

INTENDED USE

Immunoenzymatic method
determination of Prolactin (PRL) hormone in human serum,
using a disposable device applied on the Chorus TRIO
instruments.
2. INTRODUCTION
Prolactin (PRL) is a polypeptide hormone, with a molecular
weight of approximately 23.000 Da. It is composed of a single
chain of 198 amino acids and it is secreted from the anterior lobe
of the pituitary gland. The synthesis and secretion of prolactin
are regulated by hypothalamic factors such as the thyrotropin-
releasing hormone (TRH) that stimulates its production and the
dopamine that inhibits it.
Prolactin plays its most important role in females, stimulating the
development of the mammary gland and starting and maintaining
the milk secretion.
The basal concentrations of prolactin in adults present significant
circadian oscillations, with higher values during the sleeping
hours and lower values during the waking hours. Physical
exercise and stress can also cause an increase of serous
prolactin, as well as some medicines such as sulpiride and
chlorpromazine. As regards to its physiological function, prolactin
rises during pregnancy and reaches its maximum level around
the 38° week. After delivery, prolactin still maintains high values
for the whole nursing period.
The assay of prolactin is significantly useful to clarify many
clinical pictures concerning sterility problems, both in males and
females, or relative to hypothalamic-pituitary axis dysfunctions.
3. PRINCIPLE OF THE METHOD
The Chorus PRL is ready to use for the detection of the Prolactin
hormone in the Chorus TRIO instruments.
The test is based on the ELISA principle (Enzyme linked
Immunosorbent Assay).
During incubation, the PRL in the sample is simultaneously
bound to the anti-PRL monoclonal antibody present in the solid
phase and to that conjugated to horse radish peroxidise,
composing a "sandwich".
After washing to eliminate the proteins which have not reacted
the peroxidase substrate is added.
The unbound conjugate is eliminated and the peroxidase
substrate is added. The enzymatic reaction is subsequently
stopped by adding the Stop Solution that turns the solution into
yellow.
PRL
for the quantitative
The colour which develops is proportional to the concentration of
hormone present in the serum sample. The disposable devices
contain all the reagents to perform the test in the Chorus TRIO
instruments.
The results are expressed in µIU/mL.
4.

WARNINGS AND PRECAUTIONS

FOR IN VITRO DIAGNOSTIC USE ONLY
This kit contains materials of human origin which have been
tested and gave a negative response by FDA-approved
methods for the presence of HBsAg and for anti-HIV-1, anti-
HIV-2 and anti-HCV antibodies. As no diagnostic test can
offer a complete guarantee regarding the absence of
infective agents, all material of human origin must be
handled as potentially infectious. All precautions normally
adopted in laboratory practice should be followed when
handling reagents and samples.
Waste disposal: serum samples, calibrators and strips,
once used, must be treated as infectious residuals and
eliminated according to law.
Health and Safety Information
1. Do not pipette by mouth.
2. Wear disposable gloves and eye protection while handling
specimens.
3. Wash hands thoroughly after placing the devices in the
Chorus TRIO instrument.
4. Consult the relative Material Safety Data Sheet (available
on request) for all the information on safety concerning the
reagents contained in the kit.
5. Neutralized acids and other liquid waste should be
decontaminated by adding a sufficient volume of sodium
hypochlorite to obtain a final concentration of at least 1%.
A 30 minute exposure to 1% sodium hypochlorite may be
necessary to ensure effective decontamination.
6. Spillage of potentially infectious materials should be
removed immediately with adsorbent paper tissue and the
contaminated area swabbed with, for example, 1% sodium
hypochlorite before
hypochlorite should not be used on acid-containing spills
unless the spill area is first wiped dry. Materials used to
clean spills, including gloves, should be disposed of as
potentially biohazardous waste. Do not autoclave materials
containing sodium hypochlorite.
Analytical Precautions
Bring the devices to room temperature (18-30°C) before use;
use within 60 min.
1. Discard devices which show the substrate (well 4) blue
colored.
2. Adding the sample into the well verify that it is perfectly
distributed on the bottom.
3. Check for the presence of the reagents in the device and
that the device is not damaged. Do not use devices which
are lacking a reagent and/or present foreign bodies in the
reaction well when visually inspected.
4. The devices are for use with the Chorus/Chorus TRIO
instrument; the Instructions for Use must be carefully
IO-09/339-C IFU 86514 – Ed. 21.05.2018
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work is continued. Sodium