Intended Use; Warnings And Precautions - Diesse Chorus fT4 Instrucciones De Uso

INSTRUCTIONS FOR USE
CHORUS
For the quantitative determination of free
thyroxine (fT4)
For In Vitro Diagnostic Use Only
1.

INTENDED USE

Immunoenzymatic method
determination of free thyroxine (fT4) in human serum, using
a disposable device applied on the Chorus TRIO
instruments.
2. INTRODUCTION
Thyroxine (T4) is the main hormone produced by the thyroid,
stimulated by the human thyroid-stimulating hormone (hTSH). T4
mainly circulates bound to transportation proteins, such as
albumin, prealbumin and TBG (Thyroid Binding Globulin); only
the free fraction (fT4), which represents about 0.03% of the
circulating T4, is indeed active. The total T4 concentration not
only depends on the thyroid conditions of the subject and on the
peripheral conversion from T4, but also on the carrier proteins
concentration, varying with the variation of their blood levels.
The fT4 concentration, instead, does not depend on such factors
and therefore it is able to show the thyroid conditions of the
patient, with more reliable results from a diagnostic point of view.
The fT4 assay is important in case of hyperthyroidism (Graves'
disease or toxic adenoma), in case of monitoring of hypothyroid
patients treated with Thyroxine (T4) and anti-thyroid medications
and in case of low T4 syndrome (Hashimoto's thyroiditis). For a
correct diagnosis, the fT4 assay must be associated to the fT3
and TSH assay, and to the patient's clinical data.
3. PRINCIPLE OF THE METHOD
The Chorus fT4 device is ready to use for the detection of free
thyroxine in human serum, in the Chorus TRIO instruments.
The test is based on the competitive ELISA principle (Enzyme
linked Immunosorbent Assay). The anti-T4 monoclonal antibody
is bound to the solid phase and the free T4 (fT4), present in the
human sample, competes with the T4 conjugated to horse radish
peroxidase. A higher fT4 concentration in the examined sample
corresponds to a lower quantity of conjugated T4 that binds.
After washing to eliminate the components which have not
reacted, the peroxidase substrate is added. The enzymatic
reaction is subsequently stopped by adding the Stop Solution
that turns the solution into yellow.
The colour which develops is proportional to the concentration of
specific antibodies present in the examined serum.
The disposable devices contain all the reagents to perform the
test in the Chorus/Chorus TRIO instruments.
The results are expressed in pmol/l.
4.

WARNINGS AND PRECAUTIONS

fT4
for the quantitative
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 work is continued. Sodium
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
followed and the Instrument Operating Manual must be
consulted.
The use of the kit is only possible with an updated
version of software. Make sure that the software
installed in the instrument corresponds or has a
Release (Rel.) subsequent to the one reported in the
table published
(http://www.diesse.it/en/Support/Download/strumento:39/)
IO-09/335-C IFU 86520 – Ed. 07.06.2018
EN 5/22
on Diesse website