Intended Use; Warnings And Precautions - Diesse CHORUS Instructions D'utilisation

INSTRUCTIONS FOR USE
CHORUS
Tg Extened Range
For the quantitative determination of human
thyroglobulin (Tg)
For In Vitro Diagnostic Use Only
1.

INTENDED USE

Immunoenzymatic method
determination of human thyroglobulin (Tg) in human serum,
using a disposable device applied on the Chorus TRIO
instruments.
2. INTRODUCTION
Thyroglobulin (Tg) is a glycoprotein of 660 kDa localized within
the colloid of the thyroid follicle where it is synthesized under the
influence of thyrotropin. It plays an essential role in the storage
of iodine and acts as precursor for the synthesis of thyroid
hormones T3 and T4. Elevated thyroglobulin serum
concentrations have been reported in various thyroid diseases,
such as hyperthyroidism, non-toxic goitre, thyroiditis and
differentiated thyroid carcinoma.
The main clinical application for the Tg determination, however,
is represented by the post-operative monitoring of differentiated
thyroid carcinoma. The assay of Tg is used for the early detection
or exclusion of metastases, tumor relapses and the follow-up of
radioiodine treatments. Serum Tg is no detectable in patients
who underwent total thyroidectomy and are free of metastases
and tumour. These patients in true complete remission will not
display Tg levels, even by endogenous TSH stimulation.
Consequently, detectable Tg values in this group of patients are
an important indication for still existing or newly developed
neoplasia, particularly if these detectable Tg values are
increasing under a TSH-suppressive thyroid hormone treatment
(Tg profiles). For this reason a high sensitivity assay test is very
useful.
In case of patients that need an extended period monitoring, it is
recommended to keep using the same analytical test, inserting
in the same run the samples previously tested as well.
The presence of anti-Tg antibodies in the serum of the patient
can influence the Tg assay.
3. PRINCIPLE OF THE METHOD
The Chorus TG Extened Range device is ready to use for the
detection of human thyroglobulin (Tg), in the Chorus TRIO
instruments.
The test is based on the ELISA principle (Enzyme linked
Immunosorbent Assay). During two different incubations, the Tg
in the sample is bound to two different anti-Tg monoclonal
antibodies: one present in the solid phase and the other one
conjugated with Biotin.
After washing to eliminate the components which have not
reacted, incubation is performed with the conjugate, composed
of Streptavidin conjugated to horse radish peroxidase.
for the quantitative
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. 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 ng/ml calculated in reference to
BCR-457 reference material.
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 CE marked 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.
IO-09/255-C IFU 86110 - Ed. 23.10.2020
EN 6/24