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Alere Cholestech LDX® | Multianalyte Control Log Book

0161 483 5884 | [email protected] | alere.co.uk 1

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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



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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



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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.



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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



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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

[email protected]

• 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

mailto:uksupport%40alere.com?subject=Alere%20Cholestech%20LDX%20%7C%20Multianalyte%20Control%20Log%20Book



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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:



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Optional GLU

Control Lot:

Expiration Date:



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Optional GLU

Control Lot:

Expiration Date:



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Optional GLU

Control Lot:

Expiration Date:



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Optional GLU

Control Lot:

Expiration Date:



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Optional GLU

Control Lot:

Expiration Date:



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Optional GLU

Control Lot:

Expiration Date:



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Optional GLU

Control Lot:

Expiration Date:



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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.



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0161 483 5884 | [email protected] | alere.co.uk

Better information Better decisions Better health

alere cholestech ldx - gp website · contact alere 0161 483 5884 [email protected] • open a...

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