Alere Afinion ™ as100 Analyzer us

  23

Using the control ID function 

In quality control testing, a suitable control ID must always be entered. The lot number of the control material is recommended as  

a suitable control ID. The control ID function cannot be disabled.

Entering Control ID

It is recommended to enter the control ID during processing of the Test Cartridge in the Analyzer. Entering the control ID will not 

interrupt the processing. It is also possible to enter the control ID before and after processing. Both letters and numbers can be en-

tered (maximum 16 characters). The control ID will be displayed in the result records and appear on print outs and data transferred 

to data management systems.

To enter the control ID during processing, do the following:

1

Touch 

 to enter the control ID option.

2

Enter control ID by numbers and/or touch 

 to enter letters.

Touch 

 to confirm and return to the previous view.

3

The entered control ID will appear on the screen. 

The control ID touch button will remain in the view and make corrections possible.

TESTING PROCEDURES

---

24  

Using the QC lockout function 

 

When the QC lockout function is enabled for one or more assays, approved control testing is required within the configured interval. 

If the interval expires, patient testing for the assay will be locked. A passed control run must be performed according to configuration, 

to reset the interval or to unlock the assay for patient testing. A failed control run will disable patient testing (see “Configuration of QC

lockout” page 17). 

QC lockout status

The status of the enabled QC lockouts is presented with a QC lockout status button (padlock symbol) visible in the Start-up menu. 

This gives the operator the status of QC lockout before he/she attempts to run any tests. 

The padlock symbol will only be visible if QC lockout function is enabled for one or more assay types.      

The padlock symbols used are:

1

Enabled-unlocked

All controls are within the configured interval. It is possible to run patient tests for all assays.

2

Warning-unlocked 

All controls are within the configured interval. When one or more of the assays has 10 % or less of the 

configured interval remaining the warning icon will be displayed. It is possible to run patient tests for all 

assays.

3

Expired-locked 

 One or more controls have expired according to the configured interval. Patient testing on the expired 

assay has been locked.

 

4

Touch the QC lockout status button (padlock symbol) in the 

Start-up menu to enter the QC lockout status view. 

Status

The information is displayed as a list.

Only the assays with QC lockout activated are displayed in this window.   

Red text indicates expired assays and orange text indicates assays within warning period. 

Control level

How to reset QC lock interval and/or unlock expired assays.

If no control level is specified, it is required to run

 one passed control, control level C I or C II, to reset the QC 

lockout interval and unlock the assay for patient testing.

E.g.

 

HbA1c:  #0

If the control level is specified it is required to run

 two passed controls, both control level C I and C II, to reset 

the QC lockout interval and unlock the assay for patient testing.

E.g. 

 

ACR C I:  00.00.00

 

ACR C II: 00.00.00

Remaining time/runs

Remaining time (dd:hh:mm) or number of runs for each assay with active QC lockout is shown. dd is the  

number of days, hh is the number of hours, and mm is the number of minutes until the assay will be locked.  

# is number of patient tests.

TESTING PROCEDURES

---

  25

TESTING PROCEDURES

Running controls with enabled QC lockout function 

When running controls with the QC lockout function enabled, the Alere Afinion™ Control Data is required to be entered or 

 previously stored in the instrument control lot database (see “QC lockout configuration” page 17).

1) The Alere Afinion™ Control Data is entered before, during or after the control run. If a barcode scanner is connected (recommended) 

the Control Data barcode may be scanned. The control lot will automatically be stored in the instrument control database.

2) If the Alere Afinion™ Control Data is previously stored in the instrument control database, the operator will simply need to enter 

the 8 digit control lot number before, during or after the control run.

If the instrument is configured to QC lockout and the control lot number is not found in the Alere Afinion™ control database or 

the Alere Afinion™ Control Data entered is not valid, the instrument will present an option to retry the input or discard the control run 

result. If discarded, the result will not be stored in the instrument result records.

Passed (within the acceptable control range)

The result of the control is checked against the acceptable ranges for the corresponding lot number. 

If the result is within the limits, a pass symbol

is displayed on the screen and the QC lock interval is reset 

according to the QC lockout configuration. The result is stored in the instrument and is sent to the data  

management system if connected. 

          If QC lockout is configured to require two control levels (C I 

and C II), both levels must pass to reset the 

          lockout interval. Only the interval for the control level used in the test is reset.

Failed (above or below the acceptable control range)

When a control result is not within the acceptable ranges specified for the control lot, a failed symbol    

is shown on the screen. The result is stored in the instrument and is sent to the data management system  

if connected. The QC lockout interval will not be reset.

The arrow symbol will specify whether the result is above   or below    the acceptable ranges (see  

“Handling and testing controls”, page 18).

---