10 Calibration

Calibration
Working with calibrators and calibration results

This chapter tells you how to load, set up, request, and analyze results for calibrators.

In this chapter Chapter 10

About calibration .......................................................................................................B-146
Calibrators, calibration points, and curve parameters ......................................B-147
Calibrations at a glance..............................................................................................B-149
Reviewing the status of calibrators on board ...........................................................B-150
Displaying the remaining calibration interval for tests .....................................B-151
Viewing rack positions for calibrators ................................................................B-152
Viewing missing calibrators ................................................................................B-152
Loading calibrators on board ....................................................................................B-153
Requesting calibrations..............................................................................................B-155
Postponing a calibration............................................................................................B-157
Validating calibration results.....................................................................................B-159
Reviewing calibrations for validation .................................................................B-159
Reviewing calibration history .............................................................................B-161
Setting up calibrators .................................................................................................B-164
Specifying values for a new calibrator lot ...........................................................B-164
Specifying a calibration interval ..........................................................................B-166
Loading and deleting calibrator definitions .......................................................B-168
Using non-Roche calibrators ..............................................................................B-169
B

User Manual · Version 2.2 B-145

10 Calibration
About calibration

About calibration

Calibration is the process that establishes a relationship between (one or more)

measured rates and the corresponding concentration of the calibrator. The measured
rates are derived from instrument measurements, for example absorbance values.
Calibrators are often human-based serum pools with known amounts of added
analytes.

When calibrations are Calibrations are performed at regular intervals (defined in Configuration / Tests /
performed General) to compensate for changes over time in reagents and in the measurement
systems. Calibrations also have to be performed when certain physical events occur.
These include:
o A change in cassette (reagent) lot.
o A change in a defined interval.

Validating calibrations Each new calibration has to be validated either automatically or manually. No further
calibration can be performed until the previous calibration has been validated and the
results have been accepted. If flags are generated, you must determine their cause, and
decide whether to accept or rerun the calibration. If a calibration for a particular test is
not valid, all the results obtained with that test should be checked.

Lot numbers The exact compositions of calibrators and reagents vary between lots. Therefore, it is
important to check the lot numbers each time you replace a cassette or a calibrator. If
you do not update the lot numbers and values recorded on the instrument, erroneous
results can occur.

Calibration modes and Each calibration is assigned to a calibration mode by the manufacturer. Each mode
calculations represents a type of calibration curve and calibration curve parameter. From the
calibration measurements, the system calculates the values of the appropriate
parameters (called curve parameters) based on the calibration mode.

B-146 User Manual · Version 2.2

 10 Calibration
About calibration

Calibrators, calibration points, and curve parameters

Linear calibrations Tests for most enzymes and substrates have linear calibration curves, which require
only a two-point calibration.
For a linear calibration:
o A two-point calibration is used; one calibrator has a known amount of analyte, the
other is water, which is the zero calibrator.
o There are two curve parameters to be determined, known as F and R0.
o The calibrators are placed next to each other on a sample rack. The calibrator with
the highest concentration must be placed first (lower numerical position) on the
rack.

Non-linear calibrations Tests for most specific proteins, drugs of abuse testing (DAT) and therapeutic drug
monitoring (TDM) have non-linear calibrations.
For a non-linear calibration:
o Between four and six calibration points are used, depending on the calibration
mode.
o There are four (KC, R 0, A, B) or five (KC, R0, A, B, C) curve parameters, depending
on the calibration mode.
o The calibrator is supplied as either a set of bottles or a single bottle from which the
individual calibrators are made up automatically.
With a single calibrator and automatic dilution:
o There is only one calibrator to place on a rack.
o The system automatically makes up different dilutions of the calibrator to produce
the required calibration points.
With a multi-calibrator set:
o Each calibrator has a different concentration of the analyte.
o The calibrators are placed in order on a rack with the calibrator with the highest
concentration in the lowest numerical rack position.
o The software identifies individual calibrators as Std-1 (highest concentration), Std-
2 (next highest concentration) and so on.
o All the calibrators in the set must be placed in adjacent slots on the same rack.

User Manual · Version 2.2 B-147

10 Calibration
About calibration

Calibration modes Possible calibration modes are shown in the following table:

Calibration mode Attributes

Linear regression Calibration curve: A straight line based on a calculated slope

and offset.
Number of calibration points: 0 - 6
Curve parameters: R0, F
o If no calibrators are used, both curve parameters, R0 and
F, are specified in the test definition file.
o If one calibrator is used, one of the curve parameters, R0
or F, is specified in the test definition file.

Linear interpolation Calibration curve: A straight line between adjacent points

only.
Number of calibration points: 3 - 6
Curve parameters: None

Logit/log 4 Calibration curve: A curve characterized by the logit/log 4

formula, which has four calculated parameters.
Number of calibration points: 4 - 6
Curve parameters: R0, KC, A, B

Logit/log 5 Calibration curve: A curve characterized by the logit/log 5

formula, which has five calculated parameters.
Number of calibration points: 5 - 6
Curve parameters: R0, KC, A, B, C

Exponential 5 Calibration curve: A curve characterized by the Exponential 5

formula, which has five calculated parameters. This curve
has an extra turning point near the origin compared to
logit/log 5.
Number of calibration points: 5 - 6
Curve parameters: R0, KC, A, B, C

B-148 User Manual · Version 2.2

 10 Calibration
Calibrations at a glance

Calibrations at a glance

Use the following table to locate specific tasks by work area and tab.

Work area Tab Tasks

Status Missing & Blocked o Review calibrators that cannot currently be
used by the system, for example because
they are not on board, expired, or some
additional item such as a diluent is missing.

Samples o View calibrators on board; color shows the

status.
o Click a position to display the details for the
selected calibrator.

Test Status o Review test with calibrator, intervals, rack

position.

Orders Calibration o Review calibration.

o Request a calibration.
o Postpone a calibration.
o Delete a calibration request.
o Use Place Items or Sample Handling to
manually assign calibrators to rack positions.
Worklist o Review the status of pending calibration
requests during operation.

Results Validate o Review flagged calibrations.

o Display the Calibration Definitions dialog and
then Rate info.
o Accept or rerun an unaccepted calibration.
o Delete a calibration (if there are no
dependent test results).
Calibration o Review calibrations by test.
o Review curve parameters.
o Review the calibration history.
o Display the Details dialog to review data for
individual calibrations, for replicates, and
rate info.
o Rerun or accept a calibration from the
Details dialog.

Use the following table to locate specific tasks in the Configuration work area:

Icon Tab Tasks

General o Specify calibrator, sample type, and interval for a
calibration and whether replicates are to be run.

Tests
Lot o Specify a calibration lot number, expiry date, and
the assigned values for a selected calibrator and
test.
Calibrators Roche recommends to perform calibrations in
duplicate.

User Manual · Version 2.2 B-149

10 Calibration
Reviewing the status of calibrators on board

Reviewing the status of calibrators on board

You can check the status of the on-board calibrators, for example, to find out when
they need replacing.

a To view the calibrators on board

1 Click Status on the navigation bar.

2 Click the Samples tab.
Samples, controls, and calibrators are displayed graphically. Cal indicates the
presence of a calibrator.
3 Double-click a calibrator line to display details. For example:

What if?

The calibrator is expired Replace the expired calibrator with one that is not expired.

"Specifying values for a new calibrator lot" on page B-164

The calibrator is empty Replace the calibrator. Make sure the lot number is the same as the previous calibrator.
If the calibrator is from a new lot, you need to update the lot number first.

"Setting up calibrators" on page B-164

"Calibrators, controls, and diluents" on page E-20

The calibrator is blocked One or more of the calibrators are not available, or the test cassette is empty. Replace
the cassette(s) as required.

"Blocked orders, tests, calibrations, or controls" on page E-19

The calibrator is not on Load the required calibrator. Make sure the lot number of the calibrator you load is the
board same as that specified in the calibrator detail.

The calibrator definitions The system has detected a calibrator, but the calibrator definition is missing or
are missing incomplete.

"Loading and deleting calibrator definitions" on page B-168

B-150 User Manual · Version 2.2

 10 Calibration
Reviewing the status of calibrators on board

Displaying the remaining calibration interval for tests

Using the Test Calibrations function, you can display for all loaded tests, when the next
calibration is due.

a To check when a calibration is due

1 Choose Tools > Test Calibrations on the menu bar.

The Test Calibrations dialog box is displayed.

Tips
o This function is available from all work areas.
o You can click the Test Calibrations button on the toolbar instead of choosing
Tools > Test Calibrations.
o Place all calibrators on the instrument before you generate and print the list. (The
system updates the calibrator status of onboard calibrators only.)
o Click a column header to sort the list.
o Click Print to print a report with the contents of the Test Calibrations dialog box.

User Manual · Version 2.2 B-151

10 Calibration
Reviewing the status of calibrators on board

Viewing rack positions for calibrators

Typically, calibrators have a preassigned rack position on a sample rack.
(Configuration / Lab /Reserve Positions) You can also specify an ad hoc location for a
particular calibrator, for example, if you are calibrating a test that does not need
calibrating very often. The system may also use barcodes to identify calibrators.

a To view preassigned rack positions for calibrators

If the rack is on board:

1 Click Status on the navigation bar.
2 Click the Sample tab.
3 Double-click the rack number
The calibration name for each position is displayed.

"Samples tab" on page B-76

If the rack is not on board:

1 Click Configuration on the navigation bar.
2 Double-click Lab in the System group.
3 Click the Reserve Positions tab.

"To load calibrators (without barcodes)" on page B-153

Tip
You can also click Place Items in the toolbar and then select the rack.

Viewing missing calibrators

If a calibration is requested and one or more of the required calibrator(s) are not on
board, the missing calibrators are listed in the Missing & Blocked tab in the Status
work area.

a To view missing calibrators

1 Click Status on the navigation bar.

2 Click the Missing & Blocked tab.
3 Double-click the Not On Board folder in the Cals, QCs, Cleaners, Diluents, and
ISE list:

A B

A Missing calibrators identified.

B Rack number and position.

Tip
During operation, missing calibrators are also listed in the Blocked folder on the
Worklist tab of the Orders work area.

B-152 User Manual · Version 2.2

 10 Calibration
Loading calibrators on board

Loading calibrators on board

There are two ways of loading calibrators, depending on whether the calibrator tube
has a barcode or not.

a To load calibrators (with barcodes)

1 Prepare each calibrator according to the instructions on the package insert.

2 Remove the rack from its slot.
3 Transfer the calibrators to barcoded tubes on the rack.
4 Load the rack into an available slot.

Tips
o When you load a multi-calibrator set:
O All calibrators must have the same barcode.
O Contact Roche for barcode specifications.
O The calibrators must be placed consecutively on the rack, in descending
concentration order.
Start by placing the most concentrated solution in the available rack position
with the lowest number.
o The barcode reader identifies each calibrator as the rack is loaded. You do not need
to use either the Reserve Positions function or the Place Items dialog box (if you
are using barcodes).
o Use slot I, if available, for calibrators. This slot is in the cassette area, which is
cooled. Alternatively, you can use any available slot because the system identifies
the rack and its contents as it is loaded.

a To load calibrators (without barcodes)

1 Prepare each calibrator according to the instructions on the package insert.

2 Remove a sample rack (preferably the sample rack in the cooled cassette area).
3 Click Configuration on the navigation bar.
4 Double-click the Lab icon.
5 Click the Reserve Positions tab.
6 Select the rack from the list (see B, below).
7 Click + on the Calibrator folder.

User Manual · Version 2.2 B-153

10 Calibration
Loading calibrators on board

8 Drag and drop the calibrator(s) into position on the Rack graphic.

A Calibrator to place, requires one tube. The number in parentheses shows the number of tubes
required on the rack for this calibrator or calibrator set.
B Click here to choose the rack number and name of rack type.
C The rack is represented as a graphic, and the tubes that have reserved positions on the rack are
listed.

9 Click Save.
10 Click Close.
11 Insert the sample rack.

Tips
o Step 8 - For a multi-calibrator set, the system automatically reserves the required
number of positions, in the correct order. You cannot reserve positions for the
calibrators if there are not enough positions (without gaps) available.
o Step 8 - The Move calibrators icon (that is displayed when you drag calibrators into
position) shows the number of calibrators being moved.
o Click Clear to remove all the assignments from the rack.
o You can also use the Place Items dialog box to assign positions.

B-154 User Manual · Version 2.2

 10 Calibration
Requesting calibrations

Requesting calibrations

Most calibrations are scheduled to run automatically, but you may need to request a
calibration:
o If you start a new calibrator lot.
o If you change the test definition.
o If more than one cassette for the test are currently on board.
o If control measurements are outside the specified range.

Recommendations
o You should run any related control measurements after a calibration. If the
calibration and control are not flagged, you can accept the calibration, provided
this is not configured to be done automatically anyway.
o You should not accept a flagged calibration without further investigation.

a To request a calibration

1 Click Orders on the navigation bar.

2 Click the Calibration tab.
3 In the Tests & Profiles group, click the buttons for the tests that you want to
calibrate.
If more than one cassette for the test is currently on board, the Calibrate dialog box
is displayed when you click a test button in the Calibration tab in the Orders work
area.

Select the cassette you wish to use.

User Manual · Version 2.2 B-155

10 Calibration
Requesting calibrations

4 Click Save.

A
B
C
G
D
E

A You can select a test or profile for the calibration request by typing its name or number here.
B In the Configuration work area, tests can be assigned to groups. This feature can be used to reduce the
number of tests displayed at one time in this tab. Select another group if you don’t see the required test.
C Click profile buttons to request calibrations for all tests in the profile.
D Click test buttons to request a calibration for the test.
E Calibration already requested for this test.
F If you select a calibrator here, only the tests that are associated with the calibrator are displayed.
G The Calibrator/Test Summary lists all current requests for calibrations.
H Click Save to save the calibration request.

Tips
o Only calibrators with current requests are displayed.
o A full calibration means that all the calibrators defined for the test (up to a
maximum of six) must be run. The calibrators must be placed in consecutive
positions on the same rack.
o Manual requests do not reset the automatic intervals until the calibration is
accepted.
o For an ISE Multi-test, selecting a calibration for any ISE test performs the
calibration for all electrodes. No additional ISE tests are run until the calibration is
accepted.
o You cannot delete calibrations that are running.

"To delete a calibrator definition" on page B-169

o Press F1 to display Help for this tab.

B-156 User Manual · Version 2.2

 10 Calibration
Postponing a calibration

Postponing a calibration
When the system requests a calibration, you can overrule this request by postponing
the calibration.
You can postpone a calibration by moving the due date or event for the calibration.
The period by which you can postpone a calibration depends on the way the
calibration interval is defined for the test:

Due date or event Postponement period

Interval Interval

Each new cassette Until the next new cassette

Each new lot Until the next new lot

The COBAS INTEGRA 400 plus system is delivered with predefined calibration intervals for each
test. The calibration intervals are carefully defined to guarantee reagent performance within the
set on-board stability and shelf life of the reagents.
Roche does not recommend to change these default calibration intervals. Any change may alter
the reagent performance and, as a result, may lead to erroneous results.

Preconditions The following conditions must be met before you can postpone a calibration:
o A patient order exists for the test.
o An automatic calibration for the test is due now (the calibration interval has run
out).
o The test is blocked.

"Folders on the Missing & Blocked tab" on page B-75

a To postpone a calibration

1 Click the Calibration tab on the Orders work area.

2 In the Calibrator/Test Summary group, right-click the test that now requires a
calibration and choose Postpone Calibration from the context menu.
The calibration for the selected test is postponed by the period allowed for this test.

User Manual · Version 2.2 B-157

10 Calibration
Postponing a calibration

Tips
o In the Calibrator/Test Summary group, you can also choose Edit > Postpone
Calibration instead of right-clicking the selection.
o You cannot postpone a calibration in advance. This function is only available while
a test is due for calibration.
o You can postpone a calibration more than once.
o Sample and control results calculated with postponed calibrations are marked with
“p”.
o Tests with postponed calibrations are listed in the BOD report.
o The fact that a calibration was postponed is recorded in the View Message dialog
box (Messages > New Messages).
o If you select a calibrator in the Calibrator/Test Summary group instead of a test,
the Postpone Calibration option is only available if the calibration can be
postponed for all tests using this calibrator.

B-158 User Manual · Version 2.2

 10 Calibration
Validating calibration results

Validating calibration results

If any result in a calibration produces a flag, the whole calibration must be validated.
Calibrations that run without creating flags are accepted automatically, provided the
system is configured to do so (Configuration / Result Handling / Calibration).
If a calibration is flagged, you should not accept it without further investigation.

Reviewing calibrations for validation

Calibrations that require validation are displayed in the Validate tab in the Results
work area. They are also listed in the Worklist of the Orders work area.
If a calibration is not accepted, any control or test results that depend on the
calibration will be flagged and listed as well.

a To review calibrations for validation

1 Click Results on the navigation bar.

2 Click the Validate tab.
3 Select the required calibrator from the Validate list.
4 Resolve the action required from the flags generated.
5 Click the appropriate button:
Accept: Has the same effect as Accept All.
Accept All: Accept all the calibration results for the selected calibrator.
Rerun: Rerun the calibration. The current results are deleted. Any control or test
that has not been accepted yet will be rerun automatically as well.

B D

A From the list, select whether you want to display all results (All) or only the unaccepted results
(Unaccepted).
B The selected calibration.
C To resize the columns, position your cursor here and click and drag the divider. Move the divider to the
right to reveal the sample type column.
D These calibration points are flagged. Double-click for more information.
(The paper clip at the beginning of the line indicates that a comment has been entered in the Details
dialog box.)

User Manual · Version 2.2 B-159

10 Calibration
Validating calibration results

Tips
o To view additional details about the calibration, double-click a calibration line.

"Reviewing calibration history" on page B-161

o Check to see if the flagged result occurs in more than one replicate.
o For a flagged calibration, select the calibration, then perform these steps:
O Follow the recommended action for each flag.

Chapter 12, "Result flags"

O Check the assigned lot number of the calibrator against the actual lot number
on the package insert. If these are different, rerun the calibration with the
correct calibrator lot.
O Check the curve parameters against those of existing accepted calibrations for
the same test.
O To check individual calibration points, double-click one of the calibration lines
to open the Detail dialog.
o Press F1 to display Help for this tab.

Recommendations
o You should run the control measurements after a calibration. If the calibration and
controls are not flagged, you can accept the calibration, provided this is not
configured to be done automatically anyway.
o You should not accept a flagged calibration without further investigation.

B-160 User Manual · Version 2.2

 10 Calibration
Validating calibration results

Reviewing calibration history

The Calibration tab in the Results work area shows the calibration history of each test.
A calibration history lists the date and time, the curve parameters, and cassette lot
numbers for the previous and current calibrations of a particular test.
Use the calibration history to review trends (for example, to see if the instrument is
running properly) or to examine a specific calibration in detail. You can display the
calibration curve and raw data for each calibration, provided these results have not
been deleted.

a To review the calibration history

1 Click Results on the navigation bar.

2 Click the Calibration tab.
3 Select a test from the By Test list.

A
C
B

A Test name.
B This calibration is not accepted (dashed line instead of the date).
C Shows when the next calibration is due.

Tips
o Double-click a calibrator line to display the Calibration Detail dialog box.
o Double-click a test in the By Test list to show the Test Status dialog box.
o A paper clip at the beginning of a calibration line indicates a comment in the detail
dialog box.
o Scroll to the right to display lot numbers of the calibrator and reagent.
o A horizontal dotted line shows a lot change of a calibrator.
o Press F1 to display Help for this tab.

User Manual · Version 2.2 B-161

10 Calibration
Validating calibration results

a To review calibration details

1 Click Results on the navigation bar.

2 Click the Calibration tab.
3 Select a test from the By Test list.
4 Double-click a calibration line.
The Calibration Detail dialog box is displayed.

B D

C F
G

A The cassette and calibrator names and their respective lot numbers.
B Recommended user actions based on the flags generated.
C Calibration curve parameters according to the calibration mode.
D Graph of the calibration.
Double-click the graph to expand it.
Drag the cursor along the line to see rate values for each point.
E Calibrator (standard) for which values are listed.
F Mean values for the selected calibrator.
G Replicate values. Select the appropriate check box.

Buttons

Button name Function

Delete Delete this calibration. The calibration results will be lost.

Print Print details of this calibration.

Rate Info Display rate information for this calibration.
Rerun Rerun the calibration. The existing calibration results are deleted.
Accept Accept this calibration. The values from this calibration will be used
from now on to calculate results for this test.
Help Display Help for this dialog box.
Close Close this dialog box.
t v Use the arrow buttons to display values for a previous or following
calibrator.

B-162 User Manual · Version 2.2

 10 Calibration
Validating calibration results

a To review rate information for a calibration

1 Click Results on the navigation bar.

2 Click the Calibration tab.
3 Select a test from the By Test list.
4 Double-click a calibrator line.
The Calibration Detail dialog box is displayed.
5 Click the Rate Info button.
The Result Detail Rate Info dialog box is displayed.

A E

F
B
C
D G

A The cassette and calibrator names and their respective lot numbers.
B The calibration standard to which this data applies.
C Select a replicate.
D Measurement details. The parameters used and the calculation are test dependent.
E Click the Raw Data tab to review the numerical raw data vs. cycle number for this calibration.
F Test name.
G Kinetic of the reaction; graph of the raw data over time.
Double-click the graph to expand it.
Drag the cursor along the line to see rate values for each point.

User Manual · Version 2.2 B-163

10 Calibration
Setting up calibrators

Setting up calibrators

Information about a calibrator for a test is stored in the test and calibrator definitions,
which you can access through the Configuration work area.

Specifying values for a new calibrator lot

When you change calibrator lots you have to specify the lot number and expiration
date, and the assigned values of the new lot.
The procedure to update calibrator lot numbers and values depends on whether you
use a barcode pen or not.

a To manually update a calibrator lot number

1 Click Configuration on the navigation bar.

2 Double-click Calibrators in the Definitions group.
3 Select the required calibrator from the Calibrators list.
4 Click the Lot tab.

5 Click New Lot.

6 Type new values for the Lot No (Lot Number) and Exp. Date (Expiration Date),
taking the values from the calibrator package insert.
7 Click Save.
8 Select a test from the Test List.
9 Type new values for each calibrator in the set (Std-1, Std-2, and so on), also taking
these values from the calibrator package insert.
10 Click Save.

B-164 User Manual · Version 2.2

 10 Calibration
Setting up calibrators

Tips
o The system must be in Standby or Sleeping mode.
o You must have the required user access level to perform this procedure.
o Results obtained using calibration curves on the basis of the previous lot values of
this calibrator are not changed.
o Std-1 is the standard with the highest concentration.
o When updating the lot number for the ISE solutions, enter both the lot number
and expiry date of Solution 1. You can enter only one lot definition for all three
solutions.

a To update a calibrator lot number using the barcode pen

1 Click Configuration on the navigation bar.

2 Choose File > Barcode from the menu bar or click from the toolbar.
The Barcode dialog box is displayed.
3 Run the barcode pen over the first barcode line of the calibrator information sheet.
After reading the first line of barcode, the information is displayed on the Barcode
dialog box.

The numbered boxes represent the barcode lines.

4 Read the rest of the barcode lines of the calibrator information sheet.
5 Watch the Barcode dialog box.

User Manual · Version 2.2 B-165

10 Calibration
Setting up calibrators

Correctly read lines are represented by green boxes, lines with reading errors by red
boxes and a message on the Line Status box of the Barcode dialog box.

o Using the barcode pen, re-read the barcode lines that are represented by a red
box in the Line Status group of the Barcode dialog box.
o Click Reset to delete all lines and restart the whole reading process.
6 When all lines are read correctly (all boxes are green), the Barcode dialog box
closes automatically, and a message is displayed, informing you of the successful
conclusion of the reading process.

Tips
o To read and edit the read lot information, use Configuration / Calibrators / Lot or
Configuration / Controls / Lot.
o Make sure Caps Lock on your keyboard is switched off.
o If you work with laboratory units other than the Roche standard units, the values
read from the barcode sheet are automatically converted to your laboratory units,
provided you specified the Lab Unit Factor (Configuration / Tests / Laboratory).

Specifying a calibration interval

The calibration intervals for each test are defined in the test definition. You can reduce
and extend the calibration interval of a test.

The COBAS INTEGRA 400 plus system is delivered with predefined calibration intervals for each
test. The calibration intervals are carefully defined to guarantee reagent performance within the
set on-board stability and shelf life of the reagents.
Roche does not recommend to change these default calibration intervals. Any change may alter
the reagent performance and, as a result, may lead to erroneous results.

B-166 User Manual · Version 2.2

 10 Calibration
Setting up calibrators

a To specify a calibration interval

1 Click Configuration on the navigation bar.

2 Double-click Tests in the Definitions group.
3 Click the General tab.
4 Select the required test from the Installed Tests list.
5 Complete the Calibration text boxes as required.
6 Click Save.

C
D

A Selected test.
B Sample type.
C Calibrator used.
D If you select Duplicate or Triplicate, a mean value is calculated for each standard.
E Specify the interval type if necessary, and change the number of days.

Tips
o Change the Sample Type only if necessary.
o Use the calibrators recommended by Roche. If you change the calibrator, you have
to perform a new calibration.
o The system must be in Standby or Sleeping mode.
o You must have the required user access level to perform this procedure.
o You cannot modify a calibration interval if there is one or more unaccepted
calibration curve for this calibrator or if there are unaccepted sample and QC
results obtained on the basis of this calibrator.
o The options for specifying a calibration interval are:
None: No calibration interval.
Interval: Calibration at time interval only.
Cass-Lot & Interval: Calibrate at each new cassette lot or specified interval,
whichever comes sooner.
Cassette & Interval: Calibrate at each new cassette or specified interval, whichever
comes sooner.

User Manual · Version 2.2 B-167

10 Calibration
Setting up calibrators

Loading and deleting calibrator definitions

If you get an update to a calibrator definition (for example, from a new Test
Application Software (TAS)), use this procedure to load the new calibrator definition.

a To load a new calibrator definition

1 Click Configuration on the navigation bar.

2 Double-click Calibrators in the Definitions group.
3 Click Load.
The Load dialog box is displayed.

4 Click Browse and choose the drive and directory where the required calibrator
definition is located. By default, the C:\Roche\Instrument\TAS path is selected.
Alternatively, type the complete path.
5 Click OK.
The Load Calibrator Definitions dialog box is displayed.

6 Select the calibrators that you require.

7 Click Load.
A progress indicator is displayed.
8 When the calibrators have been loaded, click Cancel to close the Load Calibrator
Definitions dialog box.
If you work with a barcode pen, perform step 11 and then read the barcode with
the pen.
9 Select a calibrator from the Calibrator list
10 Click the Lot tab to review the lot information.
11 Click Save.
12 Click Close.

B-168 User Manual · Version 2.2

 10 Calibration
Setting up calibrators

Tips
o You may be asked to update calibrator definitions from the Test Application
Software (TAS) from time to time.
o Update the assigned values for a new calibrator lot from the data given on the
package insert.

a To delete a calibrator definition

1 Click Configuration on the navigation bar.

2 Double-click Calibrators in the Definitions group.
3 Click the ID tab.
4 Select a calibrator from the list.
5 Click Delete.
6 Click Yes in the Confirm Delete dialog box.

Tip
If you decide not to delete a selected calibrator after pressing the Delete key, you can
click No or Cancel in the Confirm Delete dialog box.

Preconditions
o You have sufficient user access privileges.
o The system is in Standby or Sleeping mode.
o The rack containing the calibrator is not on board.
o There are no calibration results that were obtained on the basis of this calibrator.
o The calibrator is no longer assigned to a test. You first need to assign a new
calibrator to the test (Configuration / Tests / General). Assigning a new calibrator,
automatically deletes calibration results that were obtained on the basis of the
previous calibrator.

Using non-Roche calibrators

If you want to use a non-Roche calibrator, you have to set it up and assign it to tests in
this sequence:
1. Create a calibrator definition, including name and lot number.
2. Assign the calibrator to tests; for each test, specify the number of calibrator
replicates and the interval between calibrations.
3. For the tests to which the calibrator is assigned, specify the standard concentration
levels of the calibrator.
These procedures are detailed below.

User Manual · Version 2.2 B-169

10 Calibration
Setting up calibrators

a To define a non-Roche calibrator

1 Click Configuration on the navigation bar.

2 Double-click Calibrators in the Definitions group.
3 Click the ID tab.
4 Click New Cal to clear the text boxes.
5 Type a short name, ID, and long name.
6 Click Save.
7 Click the Lot tab.
8 Click New Lot.
9 Type a lot number and expiration date.
10 Click Save.
11 Click Close.

Tips
o Step 5 - Type the ID in the format 97-nnnn-n, where n is a number between 0
and 9.
o Step 7 through 9 - You can define the lot number later, if required. (See "Specifying
values for a new calibrator lot" on page B-164.)
o Step 10 - When you click Save, an empty Test list is displayed. Tests are listed here
once you have assigned the non-Roche calibrator to tests.

a To assign a non-Roche calibrator to a test

1 Double-click Tests in the Definitions group.

2 Click the General tab.
3 Select a test from the Installed Tests list.
4 Choose the non-Roche calibrator from the Calibrator drop-down list.
5 Specify replicate and interval values for the calibrator.
6 Click Save.
7 Click Close

Tip
Repeat this procedure for all tests that use the non-Roche calibrator.

a To specify standard concentration levels for the calibrator

1 Double-click Calibrators in the Definitions group.

2 Click the Lot tab.
3 Select the non-Roche calibrator from the Calibrators list.
4 Select a test from the Test list.
5 Type concentration values for all standards, starting with the highest
concentration.

Tips
o Step 2 - Tests to which you have assigned the non-Roche calibrator are now
displayed in the Test list.
o Repeat this procedure for all the tests in the Test list.

B-170 User Manual · Version 2.2