Alere Afinion ™ as100 Analyzer us

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ANALYZER SYSTEM DESCRIPTION

How the Alere Afinion™ AS100 Analyzer System works

The Alere Afinion™ AS100 Analyzer System uses different chemical and mechanical assay methods combined with advanced,  

computerized processing and measuring technology.

A Test Cartridge with patient sample or control is placed in the cartridge chamber of the Analyzer. By manually closing the lid, the 

Test Cartridge is transported into the analysis compartment of the Analyzer.  Test and lot-specific information is obtained from the 

barcode label (Figure 2). When the Test Cartridge enters the Analyzer, the integrated camera reads the barcode. The calibration 

data for the actual lot are read, which then initiates the processing of the Test Cartridge. The sample and reagents are automatically 

transferred between the wells. An integrated camera monitors the entire process. Light-emitting diodes (LEDs) illuminate the reaction 

area, which can be either a colored membrane or a reaction well. The camera detects the reflected or transmitted light, which is  

converted to a test result and displayed on the touch screen. When the user accepts the result, the lid covering the cartridge chamber 

opens automatically and the used Test Cartridge can be removed and discarded. The Analyzer is then ready for the next run. 

Internal process control

The Analyzer self-test

A self-test is performed during start-up of the Analyzer to ensure that the instrument is operating according to established  

specifications. The self-test validates:

•  Hardware and software integrity

•  Test Cartridge transport system

•  Liquid transport system

•  Camera vision system

If the self-test fails at any point the red LED will start flashing and an information code will be displayed on the touch screen  

(see “Information codes and troubleshooting”, page 27). 

When the Analyzer is powered on for a longer period, it will automatically restart once a day to ensure that a self-test is done  

regularly. This procedure does not interrupt any analysis of the Test Cartridge. 

The fail-safe mechanisms

Fail-safe mechanisms are included to secure safe processing. The integrated camera inspects the test cartridges initially before the 

process starts and during the assay. If defects are detected (e.g. broken capillary or the cartridge is used past its expiry date), the 

Test Cartridge is rejected and an information code is displayed. During processing vital functions and components (e.g. pumps and 

heater) are supervised. When problems are detected by the built-in safety mechanism, the process will be aborted and an informa-

tion code will be displayed.

External process control

Patient ID

The Alere Afinion™ patient ID functionality will, if configured, allow up to four patient ID fields to be entered. 

The Patient ID will be stored with each patient test result in the result records.

Operator ID

The Alere Afinion™ operator functionality will, if configured, require the operators to login before testing. The functionality may also 

prevent un-authorized operators to login, perform tests and configuration. The operator ID will be stored with each test result in the 

result records.

Quality Control lockout

The Alere Afinion™ QC lockout function allows you to configure the instrument to automatically enforce your local required frequency 

of control testing. If the required control test has not been performed or the control result is outside the acceptable range, the in-

strument will disable patient testing for this assay. For manufacturer recommendations (see “Frequency of control testing” page 18).

For more information regarding these functionalities (see “Setting the configuration” page 13).

Calibration

The Alere Afinion™ AS100 Analyzer has been manufactured to deliver reliable and accurate results. During manufacturing, the Ana-

lyzers are calibrated against a reference system. This procedure has been established to ensure that all Analyzers operate within 

identical tolerance limits. 

Test specific calibration data are established for each lot of Test Cartridges and then stored in the barcode label (Figure 2).  

When the Test Cartridge enters the Analyzer, the integrated camera reads the barcode. The calibration data for the actual lot are 

transferred to the instrument and used for calculating the results. Calibration by the operator is thus not required.

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GETTING STARTED

Installing your Analyzer

Place your Alere Afinion™ AS100 Analyzer on a dry, clean, stable and horizontal surface. Make sure that the Analyzer is 

located with sufficient surrounding airspace, at least 5 inches on each side. Acclimate the Analyzer to ambient operating 

temperature (15-32°C, 59-89°F).

The Analyzer might be impaired by:

• Condensing humidity and water

• Heat and large temperature variations

• Direct sunlight

• Vibrations (e.g. from centrifuges and dishwashers)

• Electromagnetic radiation (e.g.from mobile phones)

• Movement of the Analyzer during processing of a Test Cartridge

Connecting power supply

- Connect the power cable to the power cord adapter.

- Insert the plug from the power cord adapter into the power socket (Figure 3) in the back of the Analyzer.

- Plug in the power cord to a wall outlet.

Always use the correct supply voltage. The power supply voltage must match the information quoted in the section  

“Technical specifications”, page 32.

Figure 3

1 Not in use

2 USB-A connectors for printer, USB flash and/or barcode reader

3 RS-232 port for connection to HIS or LIS systems.

4 Power input for power supply connection

Connecting additional equipment

Optional equipment, not provided with your Alere Afinion™ AS100 Analyzer are:

• External barcode reader – for reading barcoded sample or operator identification.

• Printer – for optional print out of test results.

•  Alere Afinion™ Data Connectivity Converter - For data transfer to HIS or LIS systems (see “Additional equipment”, page 32).

For additional information regarding the barcode reader, printer, and connection to HIS or LIS systems, please contact your local 

Alere Afinion™ supplier.

Connecting the equipment should be done while the Analyzer is powered off.

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