AFINION
™
2 User Manual
US | 19
Why quality control testing?
Quality control testing should be done to confirm that your Afinion 2 System is working properly and provides 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 Alere Technologies AS are recommended for use with the Afinion 2 System. These control kits contain control materials with established
acceptable ranges for the Afinion 2 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 Afinion 2 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 20-25.
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 expiration 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 retest the control material. If no procedural errors are detected, it is recommended to examine the laboratory’s quality control
record to investigate the frequency of control failures. Ensure that there is no trend in out-of-range quality control results. Retest the control material using a new
control vial.
Patient results must be declared invalid when controls do not perform as expected. Contact your Technical service representative (1.866.216.9505) for
advice before analyzing patient samples.
Frequency of control testing
It is recommended that controls are analyzed:
• When starting up an Afinion 2 Analyzer for the first time.
• With each new shipment of Afinion Test Kits.
• With each new lot of Afinion Test Kits.
• Anytime an unexpected patient test result is obtained.
• When training new personnel in the correct use of the Afinion 2 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 analyze controls at least every 30 days.
The controls should always be analyzed if an unexpected test result is obtained (see the Afinion Test Package Insert, section Test result reporting). If
local, state and/or federal regulations require more frequent testing of control materials, then quality control should be performed in compliance with these
regulations. Each laboratory site can benefit from establishing a quality control plan. The laboratory director should determine whether additional testing is
appropriate for their laboratory.
Quality Control
Содержание Afinion 2
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