Alere Afinion ™ as100 Analyzer us

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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. Only when controls are used routinely and the values are within the acceptable ranges can accurate 

results for patient samples be assured.

Choosing control material

Controls recommended by manufacturer should be used for quality control of your the Alere Afinion™ AS100 Analyzer System.  

These control kits contain control materials with established acceptable 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 outside the acceptable limits, make sure that:

-  The control vial has not passed its expiry date.

-  The control vial has not passed its open vial expiry date.

-  The control vial and Alere 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 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. Re-test 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

Controls should be analyzed:

•  When starting up an Alere Afinion™ AS100 Analyzer for the first time.

•  With each new shipment of Alere Afinion™ test kits.

•  With each new lot of Alere Afinion™ test kits.

•  Users with a low frequency of testing should analyze controls at least every 30 days. 

•  When training new operators in correct use of the Alere Afinion™ AS100 Analyzer. 

•  Anytime an unexpected test result is obtained.

•  After software upgrade of the Alere Afinion™ AS100 Analyzer.

The controls should always be analyzed if an unexpected test result is obtained (see the Alere 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

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TESTING PROCEDURES

Operating precautions

When operating the Analyzer 

•  Use your fingertip to operate the touch screen. Do not use pens or other objects that may scratch or damage the screen. 

Exception: If the screen alignment function is required, you will need to use a blunt pencil. 

•  The lid opens automatically, but must be closed manually. Do not try to open the lid manually.

•  The lid protects the cartridge chamber from dust, dirt, light and humidity. Empty the cartridge chamber and keep the lid 

closed when the Analyzer is not in use. 

•  If an information code appears on the screen during the analysis, please consult the “Information codes and trouble-

shooting” section, page 27–29.

•  Do not move the Analyzer when a Test Cartridge is being processed.

When handling the Test Cartridge

•  Do not use Test Cartridges after the expiry date, or if the Test Cartridges are not stored in accordance with the  

recommendations. 

•  Do not touch the Test Cartridge optical reading area. Hold the Test Cartridge by the handle. (Figure 2).

•  Do not use the Test Cartridge if the foil pouch, the desiccant bag or the Test Cartridge itself  is damaged. 

•  The Test Cartridges must reach recommended operating temperature before use.

•  Do not open the foil pouch until just before use. Once opened, the Test Cartridge has limited stability.

•  Handle and dispose the Test Cartridges and sample collection equipment as potential biohazardous  

materials. Use gloves. 

•  Do not re-use any part of the Test Cartridge.

Consult the Package Insert that comes with each Alere Afinion™ test kit for assay specific information.

Preparing for an Alere Afinion

TM

 analysis

-  Allow the Alere Afinion™ Test Cartridges to reach the recommended operating temperature before use. 

-  Power on your Alere Afinion™ Analyzer so it is ready for the day’s first analysis.

-  Enter the operator ID (optional). See procedure on page 22.

-  The patient ID, control ID or Alere Afinion™ Control Data can be entered before or during processing of the Test 

 Cartridge in the Analyzer. See procedures on page 21–25. 

Consult the Package Insert that comes with each Alere Afinion™ test kit for assay specific information.

1

Tear strip

2

3

Open the foil pouch. Grip the handle 

and remove the Test Cartridge from the 

pouch.

Discard the desiccant bag and foil  

pouch in suitable waste containers.

When first opened, the Test Cartridge  

has limited stability.

Inspect the Cartridge. Do not use the 

Test Cartridge if it is damaged or if 

loose desiccant particles are found on 

the Test Cartridge.

Use the handle to avoid 

touching the optical reading area.

Mark the Test Cartridge with the patient 

or control ID. Use the ID area on the Test 

Cartridge. An ID label can also be used.

Do not write on the barcode label or allow 

it to become wet, dirty or scratched.

If an ID label is used, this must fit into the 

ID area.

If a barcode reader is connected to the Analyzer, a barcoded patient ID, control ID or Alere Afinion™ Control Data can be entered.

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