Diesse CHORUS Tetanus Instructions Pour L'utilisation page 6

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 (Ref. 83606).
5. KIT COMPOSITION
PREPARATION
The kit is sufficient for 36 tests (REF 81270).
The kit is sufficient for 12 tests (REF 81270/12).
DD DEVICES
6 packages each containing 6 devices (REF 81270).
2 packages each containing 6 devices (REF 81270/12).
Description:
Position 8: Space for application of bar code label
Position 7: Empty
Position 6: MICROPLATE WELL
Coated with Tetanus Toxoid antigen
Position 5: Uncoated MICROPLATE WELL
Position 4: TMB SUBSTRATE
Contents: Tetramethylbenzidine 0.26 mg/ml and H
stabilized in 0.05 mol/L citrate buffer (pH 3.8)
Position 3: SAMPLE DILUENT
Contents: Proteic solution containing sodium azide 0.09%
Positon 2: CONJUGATE
Contents: anti-human IgG antibodies labelled with horseradish
peroxidase, in proteic solution containing preservative.
Position 1: EMPTY WELL
In which the operator must place the undiluted sample
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.
CALIBRATOR CALIBRATOR
Contents: Diluted human serum containing anti-Tetanus toxin
IgG antibodies and preservative. Liquid, ready for use.
CONTROL + POSITIVE CONTROL
Contents: Diluted human serum containing anti-Tetanus toxin
IgG antibodies and preservative. Liquid, ready for use.
MATERIALS REQUIRED BUT NOT PROVIDED
•
WASHING BUFFER REF 83606
•
CLEANING SOLUTION 2000 REF 83609
•
SANITIZING SOLUTION REF 83604 - 83608
•
Chorus/Chorus TRIO Instrument
•
Distilled or deionised water
AND REAGENT
O 0.01%
2 2
1 x 0.175 ml
1 x 0.425 ml
•
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 positive control
(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 8 weeks at 2/8°C
CALIBRATOR 8 weeks at 2/8°C
POSITIVE CONTROL 8 weeks at 2/8°C
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 sample may be stored for 7 days at 2/8°C, or frozen
for longer periods at –20°C.
Freeze-thawing cycles have to be avoided.
Do not keep the samples in auto-defrosting freezers.
Defrosted samples must be shaken carefully before use.
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 50 µl of undiluted test sample in well no. 1 of
each device; at each change of batch, use a device for the
calibrator.
4. Place the devices in the Chorus/Chorus TRIO instrument.
Perform the calibration (if necessary) and the test as
reported in the Instrument Operating Manual.
9. TEST VALIDATION
Use the positive control to check the validity of the results
obtained. It should be used as reported in the Instrument
Operating Manual. If the instrument signals that the positive
control has a value outside the acceptable range, the
calibration must be repeated. The previous results will be
automatically corrected.
If the result of the positive control continues to be outside the
acceptable range, contact the Scientific Support.
Tel: 0039 0577 319554
Fax: 0039 0577 366605
email: scientificsupport@diesse.it
IO-09/381-C IFU 81270-81270/12 – Ed. 16.09.2020
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