Why Quality Control Testing; Choosing Control Material; Handling And Testing Controls; Frequency Of Control Testing - Abbott ALERE AFINION AS100 Manual Del Usuario

Quality Control

Why quality control testing?

Quality control testing should be done to confirm that your Alere Afinion AS100 Analyzer System is working properly and providing
reliable results. Accurate results for patient samples can only be assured when controls are used routinely and the values are within
the acceptable ranges.

Choosing control material

Controls supplied by Abbott Diagnostics Technologies AS are recommended for use with the Alere Afinion AS100 Analyzer System.
These control kits contain control materials with established acceptable ranges for the Alere Afinion AS100 Analyzer System.
If you decide to use controls from another supplier, you will need to determine their precision and to establish acceptable control
ranges for the Alere Afinion AS100 Analyzer System.

Handling and testing controls

Consult the Package Insert that comes with each control kit for detailed instructions on handling and storage of the control
material.
To run a control, follow the procedure in the section "Testing procedures", page 19–26.
The measured value should be within the acceptable range stated on the control vial label or in the control package insert. If the
control results are within the acceptable ranges, patient samples may be tested and results reported.
If the result obtained for a control is out of range, make sure that:
- The control vial has not passed its expiry date.
- The control vial has not passed the declared stability for opened vials.
- The control vial and Afinion Test Cartridges have been stored according to recommendations.
- There is no evidence of bacterial or fungal contamination of the control vial.
Correct any procedural error and re-test the control material. If one or more control results are still out of range:
- Analyse a control sample from a new vial.
If the advice above is followed and the control results are still outside the stated acceptable ranges, contact your local Alere
Afinion supplier for assistance before proceeding to analyse patient samples.

Frequency of control testing

It is recommended that controls are analysed:
• When starting up an Alere Afinion AS100 Analyzer for the first time.
• With each new shipment of Afinion test kits.
• With each new lot of Afinion test kits.
• If an unexpected patient test result is obtained.
• When training new personnel in the correct use of the Alere Afinion AS100 Analyzer System.
• If national or local regulations require more frequent testing of control materials, perform quality control in compliance with the
regulations for your facility.
• Users with a low frequency of testing should analyse controls at least every 30 days.
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