bioMérieux
®
SA
English - 1
80 000
12767
B
- en - 2007/12
TEMPO
®
QC
For microbiological control only
Kit for the verification of TEMPO Reader measurement performance
SUMMARY AND EXPLANATION
TEMPO QC should only be used with the TEMPO system.
The TEMPO QC kit is used to check TEMPO Reader
measurement performance. Each control kit is intended
for single use only.
The kit should be used to confirm that the instrument is
functioning correctly and ensure that the fluorescence
readings are accurate.
PRINCIPLE
The TEMPO QC kit consists of 5 vials of standard solution
and 5 control cards. All the kit components are ready-to-
use.
Each vial and each card is identified by a pictogram (8 or
20).
Each vial is associated with a card which has the same
pictogram. The TEMPO Filler fills each card with the
solution contained in the matching vial. It also seals the
card to avoid any risk of contamination during subsequent
handling.
The solution contained in the cards emits a calibrated
fluorescent signal which depends on its concentration of
4-Methylumbelliferone (8 or 20 µmol.l
-1
). The light signal
detected by the TEMPO Reader, is evaluated by
comparison with an expected value.
CONTENT OF THE KIT (Kit for 1 control):
-
3 TEMPO QC 13 ml vials.8 µM
-
2 TEMPO QC 13 ml vials.20 µM
-
3 TEMPO QC cards.8 µM
-
2 TEMPO QC cards.20 µM
-
1 package insert
COMPOSITION OF THE VIALS OF STANDARDS
4-Methylumbelliferone
Standard 8 µM
8 µmol.l
-1
Standard 20 µM
20 µmol.l
-1
Volume of the vials: 13 ml
WARNINGS AND PRECAUTIONS
x
For microbiological control only.
x
For professional use only.
x
This kit is for single use only.
x
Do not incubate the control cards.
x
It is critical to correctly match the vials and control cards
with the same pictograms (8 or 20).
x
Do not use kit components after the expiry date
indicated on the box label.
x
Do not mix components from different lots.
x
Before use, check that the packaging and components
are intact.
x
Allow the components to come to room temperature in
their box before use.
x
Do not use visibly deteriorated cards.
x
The TEMPO Reader, TEMPO Filler and racks should be
regularly cleaned and decontaminated (see the User’s
Manuals).
x
Any change or modification in the procedure may affect
the results and must be validated by the laboratory.
bioMerieux will not be held liable for results obtained
following any changes or modifications in procedures
not validated by bioMerieux. In addition, such changes
or modifications may void all warranties.
STORAGE CONDITIONS
x
Store the components of the TEMPO QC kit between
2°C and 8°C in their box protected from the light.
x
If stored according to the recommended conditions, all
components are stable until the expiry date indicated on
their label.
x
After opening the kit, do not leave the components
exposed to direct light.
TEST FREQUENCY
It is recommended to check the TEMPO Reader
measurement performance once a month.
INSTRUCTIONS FOR USE
For complete instructions, see the TEMPO system User's
Manuals (TEMPO Check chapter).
1. Prior to use, allow the TEMPO QC kit to come to room
temperature, then remove the components from their
box.
2. Check the expiry date of each of the components.
3. Put each vial in the filling rack and insert the cards
with the same pictogram opposite the vial. The
transfer tube of each card should be placed inside the
matching vial.
4. Place the rack in the TEMPO Filler and start the filling-
sealing cycle. The TEMPO Filler simultaneously fills
the cards, then cuts and seals the transfer tubes.
5. Remove the filling rack from the TEMPO Filler.
NOTE:
There is a residual volume of standard solution
in the vials after the filling cycle.
6. Take the cards out of the filling rack and transfer them
into the reading rack, ensuring that the label of each
card is facing the user (towards the rack handle) and
that the cards are properly inserted into the following
positions:
-
the three 8 µM cards: rack positions 1, 2 and 3.
-
the two 20 µM cards: rack positions 4 and 5.
7. Dispose of the used vials and transfer tubes into an
appropriate receptacle.
