Upload
others
View
3
Download
0
Embed Size (px)
Citation preview
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 1
GB
0002
6-R
EV1-
02.1
0.14
-AP
P
Alere Cholestech LDX®
Internal Quality Control Process - User Guide including Log Book
0161 483 5884 | [email protected] | alere.co.uk
Better information Better decisions Better health
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 2
GB
0002
6-R
EV9-
02.1
0.14
-AP
P
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 3
GB
0002
6-R
EV1-
02.1
0.14
-AP
P
Multianalyte Quality Control Materials
Unopened control vial stability
Stable until expiry date indicated on the vial label when stored refrigerated (2-8°C)
Opened control vial stability
Stable for 30 days when stored refrigerated (2-8°C). Record the open date on the vial label
Pack size
Catalogue Number
88773
Level 1 1 x 250µl
Level 2 1 x 250µl
Catalogue Number
88769
Level 1 2 x 2mL
Level 2 2 x 2mL
Storage Instructions
Avoid exposure to direct sunlight
Do not freeze
Do not use the LDX Multianalyte Controls after their expiry date or if they have not been stored in accord-
ance with recommendations
Sample PreparationAllow the control material to reach room temperature (15-25°C) before use, remove from the refrigerator
for at least 10 minutes before use.
Mix the control material well by inverting the vial 8-10 times before collecting a sample
Your Multianalyte Quality Control material will be delivered as per your local delivery schedule.
When you receive each delivery, please place the package directly in the refrigerator and discard any previous vials
that have expired.
For in vitro diagnostic use only. For warnings and precautions please see Appendix 1
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 4
GB
0002
6-R
EV9-
02.1
0.14
-AP
P
Running Multianalyte Controls
Step 1 - Prepare necessary equipment:
1. Multianalyte Controls
a. Remove vial(s) from the refrigerator
b. Check expiry dates
c. Gently invert vial(s) 8-10 times
2. MiniPet Pipette
a. Place a pipette tip firmly onto the end of the MiniPet pipette.
Please note, a new tip is required for every sample being tested.
3. Test cassettes
a. Ensure correct storage - bring to room temperature
b. Check expiry dates
4. LDX instrument
a. Ensure LDX is powered on
Step 2 – Collect and apply sample1. Remove test cassette from foil pouch
2. Holding it by the short sides, place it on a flat surface
3. Depress the plunger of the MiniPet pipette and place the tip into the Multianalyte
control vial
4. With the tip just below sample level, slowly release the plunger to draw up the
sample
5. To apply the sample to the test cassette, place the tip of the pipette tip into the
sample well and press the plunger down slowly until the entire sample has been
expelled.
DO NOT RELEASE THE PLUNGER until the pipette tip has been removed
from the sample well.
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 5
GB
0002
6-R
EV1-
02.1
0.14
-AP
P
Running Multianalyte Controls
Step 3 – Run the sample1. Press ‘RUN’ and the cassette drawer will open. The following message will be
displayed:
2. Immediately place the cassette inside the analyser drawer with the black test
bar innermost and brown magnetic on the right hand side.
3. Press ‘RUN’ and the drawer will close automatically. The following message
will be displayed:
4. When the test has finished, the analyser will beep and the drawer will open
automatically.
5. Discard the used cassette and used pipette tip in the appropriate waste
containers.
6. Replace the vial lid and return to the refrigerator.
REPEAT THIS PROCESS FOR BOTH LEVELS OF MULTIANALYTE
CONTROL
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 6
GB
0002
6-R
EV9-
02.1
0.14
-AP
P
Multianalyte Quality Controls
Expected Multianalyte Quality Control Values
Refer to the Expected Values Card included in the Multianalyte Control packet for expected values for each
analyte
Be sure that the lot numbers on the vials of the Controls correspond to the lot numbers on the Expected Values
Card
Ensure the result falls within the expected range for each analyte
Record the results in a Quality Control Log
Decision Tree:
Check the expiry date on the QC
material and cassettes. If OK
repeat the QC. Are the results
now within the specified limits?
Contact Alere
0161 483 5884
• Open a fresh vial of Multianalyte control material
and a new box of test cassettes.
• Clean the magnetic head of the LDX as per relevant
instructions.
• Repeat the Multianalyte control process.
• Are the results now within the specified limits?
Yes No
NoYes
Proceed with client testing
Proceed with client testing
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 7
GB
0002
6-R
EV1-
02.1
0.14
-AP
P
Multianalyte Control Level 1
Date Cassette Lot No. Analyte Value Accept Reject Operator Comments/Actions taken
Control Range: TC HDL
Optional GLU
Control Lot:
Expiration Date:
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 8
GB
0002
6-R
EV9-
02.1
0.14
-AP
P
Multianalyte Control Level 2
Date Cassette Lot No. Analyte Value Accept Reject Operator Comments/Actions taken
Control Range: TC HDL
Optional GLU
Control Lot:
Expiration Date:
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 9
GB
0002
6-R
EV1-
02.1
0.14
-AP
P
Multianalyte Control Level 1
Date Cassette Lot No. Analyte Value Accept Reject Operator Comments/Actions taken
Control Range: TC HDL
Optional GLU
Control Lot:
Expiration Date:
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 10
GB
0002
6-R
EV9-
02.1
0.14
-AP
P
Multianalyte Control Level 2
Date Cassette Lot No. Analyte Value Accept Reject Operator Comments/Actions taken
Control Range: TC HDL
Optional GLU
Control Lot:
Expiration Date:
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 11
GB
0002
6-R
EV1-
02.1
0.14
-AP
P
Multianalyte Control Level 1
Date Cassette Lot No. Analyte Value Accept Reject Operator Comments/Actions taken
Control Range: TC HDL
Optional GLU
Control Lot:
Expiration Date:
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 12
GB
0002
6-R
EV9-
02.1
0.14
-AP
P
Multianalyte Control Level 2
Date Cassette Lot No. Analyte Value Accept Reject Operator Comments/Actions taken
Control Range: TC HDL
Optional GLU
Control Lot:
Expiration Date:
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 13
GB
0002
6-R
EV1-
02.1
0.14
-AP
P
Multianalyte Control Level 1
Date Cassette Lot No. Analyte Value Accept Reject Operator Comments/Actions taken
Control Range: TC HDL
Optional GLU
Control Lot:
Expiration Date:
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 14
GB
0002
6-R
EV9-
02.1
0.14
-AP
P
Multianalyte Control Level 2
Date Cassette Lot No. Analyte Value Accept Reject Operator Comments/Actions taken
Control Range: TC HDL
Optional GLU
Control Lot:
Expiration Date:
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 15
GB
0002
6-R
EV1-
02.1
0.14
-AP
P
Multianalyte Quality Controls
Appendix 1:
Warnings and Precautions
For in vitro diagnostic use only
Human and animal source material. Treat as potentially infectious.
The human source material used to produce this product has been tested using FDA-accepted methods and
found nonreactive for hepatitis B surface antigen (HBsAg), and for antibodies to hepatitis C (HCV) and human
immunodeficiency viruses (HIV-1 and HIV-2). Because no test can offer complete assurance that infectious agents
are not present, this product should be considered potentially infectious and handled with the same precautions
used with patient specimens.
Alere Cholestech LDX® | Multianalyte Control Log Book
0161 483 5884 | [email protected] | alere.co.uk 16
GB
0002
6-R
EV9-
02.1
0.14
-AP
P
alere.co.uk
© 2
014
Ale
re. A
ll rig
hts
rese
rved
. All
trad
emar
ks r
efer
ence
d a
re t
rad
emar
ks o
f the
ir re
spec
tive
owne
rs. G
B00
026-
RE
V1-
02.1
0.14
-AP
P
0161 483 5884 | [email protected] | alere.co.uk
Better information Better decisions Better health