Diesse CHORUS Instructions D'utilisation page 7

4. The devices are for use with the Chorus TRIO instrument;
the Instructions for Use and the Instrument Operating
Manual must be carefully followed.
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 on Diesse website
(https://www.diesse.it/en/downloads/downloads/strumento:
39/)
5. Check that the 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.
8. Defective barcodes can be inserted manually in the
instrument (see Operating Manual).
9. Do not expose the devices to strong light or to hypochlorite
vapors during storage and use.
10. The use of strongly hemolyzed, lipemic, icteric samples, of
serum not completely coagulated or of samples presenting
microbial contamination may all constitute sources of error.
11. Do not use the device after the expiry date.
12. Make sure that the instrument is connected to the
Washing Buffer Autoimmunity (Ref. 86004).
5. KIT COMPOSITION
PREPARATION
The kit is sufficient for 36 tests.
DD DEVICES 6 packages each containing 6 devices
Description:
Position 9: Space for application of bar code label
Position 8: STREPTAVIDIN-POD
Contents: Streptavidin conjugated to peroxidase, in phosphate
buffer solution containing phenol 0.05% and Bronidox 0.02%.
Position 7: MICROPLATE WELL
Coated with anti-Tg monoclonal antibodies
Position 6: MICROPLATE WELL
Coated with anti-Tg monoclonal antibodies
Position 5: TMB SUBSTRATE
Contents: Tetramethylbenzidine 0.26 mg/mL and H
stabilized in 0.05 mol/L citrate buffer (pH 3.8)
Position 4: SAMPLE DILUENT
Contents: saline proteic solution with Proclin (0.1%)
Position 3: STOP SOLUTION
Contents: 0.3 M sulfuric acid solution
Position 2: CONJUGATE
Contents: anti-Tg monoclonal antibodies labeled with Biotin, in
phosphate buffer containing phenol 0.05% and Bronidox 0.02%.
Position 1: EMPTY WELL
in which the sample is transferred.
Use: equilibrate a package at room temperature, open the
package and remove the required devices; replace the others in
the bag with the silica gel, expel the air and seal by pressing the
closure. Store at 2-8°C.
AND REAGENT
O 0.01%
2 2
CALIBRATOR CALIBRATOR
Contents: Buffer containing Tg and preservative. Liquid, ready to
use.
CONTROL + POSITIVE CONTROL
Contents: Buffer containing Tg and preservative. Liquid, ready to
use.
MATERIALS REQUIRED BUT NOT PROVIDED
•
WASHING BUFFER AUTOIMUNITY REF 86004
•
CLEANING SOLUTION 2000 REF 83609
•
SANITIZING SOLUTION REF 83604 - 83608
•
CHORUS NEGATIVE CONTROL/SAMPLE DILUENT REF
83607
•
Chorus TRIO Instrument
•
Distilled or deionised water
•
Normal laboratory glassware: cylinders, test-tubes etc.
•
Micropipettes for the accurate collection of 50-200 µl
solution
•
Disposable gloves
•
Sodium Hypochlorite solution (5%)
•
Containers for collection of potentially infectious materials
6. STORAGE AND STABILITY OF REAGENTS
Reagents must be stored at 2/8°C. In the case of storage at
an incorrect temperature the calibration must be repeated
and the run validated using the control serum (see section
9, Test validation).
The expiry date is printed on each component and on the kit
label.
Reagents have a limited stability after opening:
DEVICES
CALIBRATOR
POSITIVE CONTROL
7. SPECIMEN COLLECTION AND STORAGE
The sample is composed of serum collected in the normal
manner from the vein and handled with all precautions dictated
by good laboratory practice.
Possible consequences, in case of use of other biological liquids,
are not known.
The fresh serum may be stored for 4 days at 2/8°C, or frozen for
longer periods at –20°C. Can be thawed a maximum of 3 times.
Do not keep the samples in auto-defrosting freezers. Defrosted
samples must be shaken carefully before use.
Heat-inactivation can rise to erroneous results.
The quality of the sample can be seriously affected by microbial
contamination which leads to erroneous results.
8. ASSAY PROCEDURE
1. Open the package (on the side containing the pressure-
closure), remove the number of devices required and seal
the rest in the bag after expelling the air.
2. Check the state of the device according to the indications
reported in chapter 4, Analytical Precautions.
3. Dispense 150 µl of undiluted test serum in well no. 1 of each
device; at each change of batch, use a device for the
calibrator.
IO-09/255-C IFU 86110 - Ed. 23.10.2020
1 x 0.500 ml
1 x 1 ml
8 weeks at 2/8°C
8 weeks at 2/8°C
8 weeks at 2/8°C
EN 7/24