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

INSTRUCTIONS FOR USE
CHORUS
Tetanus IgG
For the quantitative determination of anti-
Tetanus toxin IgG antibodies
For In Vitro Diagnostic Use Only
1.

INTENDED USE

Immunoenzymatic method
determination of IgG class antibodies against Tetanus
toxin in human serum, using a disposable device applied
on the Chorus and Chorus TRIO instruments.
2. INTRODUCTION
Tetanus is a disease caused by the toxin from Clostridium
tetani. Through better hygienic conditions and a wide
prophylaxis by vaccination, the disease rate could be
decreased worldwide. The protection through vaccination is
very rare in older persons, because Tetanus antitoxin levels
decline with age.
Sufficient protection is achieved by vaccination and following
booster injections.
Even if vaccination has a very low risk, it is advisable to detect
the immunity before boostering.
Protection begins at a level of 0.1 IU/mL of anti-Tetanus Toxoid.
3. PRINCIPLE OF THE METHOD
The Chorus Tetanus IgG device is ready to use for the
detection of IgG antibodies against Tetanus toxin, in the
Chorus/Chorus TRIO instruments.
The test is based on the ELISA principle (Enzyme linked
ImmunoSorbent Assay). The antigen is bound to the solid
phase. The specific immunoglobulins are bound to the antigen
through incubation with diluted sample.
After washing to eliminate the proteins which have not reacted,
incubation is performed with the conjugate, composed of anti-
human IgG antibodies conjugated to horseradish peroxidase.
The unbound conjugate is eliminated, and the peroxidase
substrate added. The blue colour which develops is
proportional to the concentration of specific antibodies present
in the sample.
The disposable devices contain all the reagents to perform the
test when applied on the Chorus/Chorus TRIO instruments.
The results are expressed in milli-International Units (mIU/ml)
calculated in reference to Who Reference Preparation 76/589".
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-
for the quantitative
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 material of human origin.
Waste disposal: 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/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
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/)
5. Check that the Chorus/Chorus TRIO instrument is set up
correctly (see Operating Manual).
6. Do not alter the bar code placed on the handle of the
device in order to allow correct reading by the instrument.
7. Avoid using self-defrosting freezers for the storage of the
samples.
IO-09/381-C IFU 81270-81270/12 – Ed. 16.09.2020
EN 5/34
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