cobas series - Roche

cobas® 8000 modular analyzer series<cobas e 801 analytical unit>Test Installation Guide - Elecsys® Anti-SARS-CoV-2

Roche Diagnosticscobas® 8000 analyzer series · Publication version 1.0 · Test Installation Guide - Elecsys® Anti-SARS-CoV-2 ·

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Publication information

Edition notice This Test Installation Guide supplements the

Operator’s Manual of cobas® 8000 modular analyzer

series and the Method Sheet for Elecsys® Anti-SARS-CoV-2.

Every effort has been made to ensure that all the information contained in this document is correct at the time of publication.

It is mandatory for system operators to read the Operator’s Manual and Method Sheet thoroughly before using the analyzer and assay.

The Online Help contains all information about the product.

Operator Only trained staff is able to work safely with cobas® 8000 modular analyzer series. Therefore, handling the system is restricted for trained operators. When working with biohazardous material, be sure to strictly follow the GLP rules.

Safety The safety statements are given in the Safety Guide of

cobas® 8000 modular analyzer series.

For their own safety, operators of cobas® 8000 modular analyzer series must be familiar with the safety statements and are required to observe them when working with the analyzer.

Copyright © 2020, Roche Diagnostics GmbH.All rights reserved.

Publication version Revision date Change description

1.0 2020-05 First version

y Revision history


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Contact addresses

Inside the European Union andEFTA member states

Outside the European Union andEFTA member states

Manufacturer of the instrument

Hitachi High-Technologies Corporation1-24-14 Nishi-ShimbashiMinato-ku Tokyo 105-8717Japan

Authorized representative

Roche Diagnostics GmbHSandhofer Strasse 11668305 MannheimGermany

Manufactured by: Hitachi High-Technologies Corporation

Manufactured for: Roche Diagnostics GmbHSandhofer Strasse 11668305 MannheimGermany


4 Installing Elecsys® Anti-SARS-CoV-2

Installing Elecsys® Anti-SARS-CoV-2The ACOV2 reagent pack comes with inpack calibrators. The calibrator lot has to be downloaded separately from cobas link.

To install Elecsys® Anti-SARS-CoV-2, follow the procedures in the given order.

d m Method Sheet

m Short Guide: Preparation of Quality Control materials for use in Elecsys Anti-SARS-CoV-2

j • The system is in Stand By mode.

• You are logged on as administrator.

r To verify loaded e-barcodes

1 Ensure that all relevant e-barcodes are available in cobas link and TSN Agent.

• If required, load the latest cobas e-library CDs.

r To download ACOV2 test

1 Choose Utility > Application, then choose the Download button.

f The Download dialog box is displayed.

2 In the Search Using group box, choose the Application Name option.

• From the Application Name drop-down list, choose the ACOV2 test.

I Alternatively, choose the Application Code option, then choose the ACOV2 application code: 10226.

3 Choose the Search button.

f The ACOV2 test is displayed in the table.

4 If you get the message ITEM NOT FOUND:

• Ensure that the search criteria are correct.

• Repeat the procedure:To verify loaded e-barcodes p.

• Repeat steps 1 to 3.


Installing Elecsys® Anti-SARS-CoV-2 5

5 In the Selection column, select the check box of the ACOV2 test.

• Choose the Download button.

f The Confirmation dialog box is displayed.

6 Review the displayed information.

• In the Sample Type group box, select the Ser/Pl check box and the Others check box.

• Choose the OK button.

f The ACOV2 test is downloaded and automatically assigned to all available analytical units and measuring cells.

7 In the Download dialog box, choose the Close button.

r To download ACOV2 calibrator

1 Choose Calibration > Install, then choose the Download button.


2 In the Search Using group box, choose the Calibrator option.

• From the Calibrator drop-down list, choose the ACOV2 test.

I Alternatively, choose the Lot ID option, then enter the calibrator lot in the Lot ID field.


f The search results are displayed in the table.

4 In the Selection column, select the check box of the ACOV2 calibrator item to be downloaded.

• Choose the Download button.




5 Review the displayed information.


f The ACOV2 calibrators are downloaded and installed.

6 In the Download dialog box, choose the Close button.

r To assign ACOV2 test to a test key

1 Choose Utility > System then choose the Key Settings button.

f The Key Settings dialog box is displayed.

2 Choose an empty test key (No Setting button).

f The Test Key Settings dialog box is displayed.

3 In the Test / Profile table, choose the ACOV2 test.


f The Key Settings dialog box is displayed.

4 Choose the Update button, then choose the OK button.

r To define ACOV2 test assignment

1 Choose Utility > System Configuration, then choose the Test Assignment button.

f The Test Assignment dialog box is displayed.



2 Choose the e 801 analytical unit.

f The Test Assignment dialog box for the analytical unit is displayed.

3 In the Test column, choose the ACOV2 test.

• To assign the ACOV2 test to measurement channel 1 and/or 2, select the Ch.1 check box and/or the Ch.2 check box.

I The ACOV2 test is assigned to both measuring channels by default. If required, change the setting.

4 Choose the OK button.

f The Test Assignment dialog box for the analytical unit is displayed.

5 If an additional e 801 analytical unit is connected, repeat steps 2 to 4.

6 Choose the Close button.

r To define ACOV2 reagent warning levels

1 Check customer request for ACOV2 reagent warning levels.

2 Choose Utility > System, then choose the Reagent Level button.

f The Reagent Level dialog box is displayed.

3 In the Test column, choose the ACOV2 test.

4 In the Yellow Alarm group box and Purple Alarm group box:

• Select the Activate Alarm check box.

• In the Tests field, enter the number of remaining determinations.

I Recommendation:Yellow threshold: 10% of daily consumption.Purple threshold: 110% of daily consumption.



5 Choose the Update button, then choose the OK button.

r To load ACOV2 reagent pack

1 Load the ACOV2 reagent pack.

2 Choose Reagent > Setting.

• From the Module drop-down list, choose the e 801 analytical unit.

• Verify that the ACOV2 test is listed in the Test column.

r To perform calibration

1 Choose Calibration > Status• In the Test column, choose the ACOV2 test.

• From the Method drop-down list, choose the Full option.

2 To request the calibration, choose the Save button.

3 Load the ACOV2 calibrators on a calibrator rack.

4 Perform calibration.

r To check calibration results

1 Choose Print > History.

• In the Report Name column, choose the Calibration Monitor report.

I If the Calibration Monitor report is not displayed, choose the Refresh button.

f The Calibration Monitor report is displayed.



2 Verify that the calibration is successful.

I If the calibration failed, check the data alarm and refer to the Operator’s Manual or Online Help.

r To prepare QC material

1 Prepare QC material and establish target values as stated in:

• Method Sheet

• Short Guide: Preparation of Quality Control materials for use in Elecsys Anti-SARS-CoV-2

r To install non-Roche QC material

1 Log on to data manager.

2 In data manager, choose the QC Parameter workplace.

• Choose the QC material component.

• Right-click the QC material work area.

• Choose the Insert QC material command.

f The Insert QC material dialog box is displayed.

3 Enter information as stated in the Method Sheet.

• If required, select the Lock validation check box in the Test group box.

f If you select the Lock validation check box, patient results are blocked in case of QC error.

f If you clear the Lock validation check box, patient results are sent to LIS independent of QC result.

4 In the Test group box, enter the following fields as required:

• Target Value• SDI Values in screenshot are illustrative.

To calculate your own target values, refer to Short Guide: Preparation of Quality Control materials for use in Elecsys Anti-SARS-CoV-2.




6 Repeat steps 2 to 5 for the second level of QC.

r To download ACOV2 QC material

1 Choose QC > Install, then choose the Download button.


2 In the Search Using group box, choose the Control option.

• From the Control drop-down list, choose the ACOV2 QC material.

I Alternatively, choose the Lot ID option, then enter the calibrator lot in the Lot ID field.


f The search results are displayed in the Result table.

4 In the Selection column, select the check box of the ACOV2 QC material, then choose the Download button.


5 Review the displayed information, then choose the OK button.

f The ACOV2 QC material is downloaded.

6 Repeat steps 1 to 5 for the second level of QC.

r To assign ACOV2 QC material to rack positions

1 Choose QC > Controls, then choose the Rack Assign button.

f The Rack Assign dialog box is displayed.



2 In the Control column, choose the ACOV2 QC material.

• In the Rack No. - Pos. column, choose an empty rack position.

• Choose the Add > button.

• Repeat step 2 for the second level of QC.


r To assign QC rules to the ACOV2 test

1 In data manager, choose the QC Parameter workplace, then choose the QC rule assignment component.

2 In the QC rule column, choose the rule as required.

I Do not select the Status check box next to the QC rule column. It displays the Enable / Disable QC rule dialog box that is used to set the severity level for all tests.

3 In the Test table, select the Status check box of the ACOV2 test.

f The Enable / Disable QC rule dialog box (for the selected test) is displayed.

4 Choose severity level as required.

f The ACOV2 test is set to the corresponding severity level.

f In the Test table, the Status check box of the ACOV2 test is selected, indicating that the selected QC rule is now assigned to it.

f The Status check box next to the QC rule column is shaded, indicating that the QC rule is assigned to one or more tests.



r To check the pass-through mode settings (service only)

1 In data manager, choose the Service workplace, then choose the Service-related configuration component.

2 Choose the Interface options tab and check the settings in the Pass-through for results group box.

• If pass-through mode is deactivated, proceed with procedure:To define reference range (service only) p

• If pass-through mode is activated, proceed with procedure:To ignore reference range (service only) p


r To define reference range (service only)

1 In data manager, choose the Test Configuration workplace, then choose the Test / reference ranges component.

• Double-click the ACOV2 test.

f The Test / reference ranges dialog box is displayed.

2 In the Workflow group box, select the Validate repetitions check box.

3 Right-click an empty area in the Reference ranges tab.

• Choose the Insert reference ranges option.

f The Insert reference ranges dialog box is displayed.

4 Enter the reference range as required, then choose the OK button.

• Proceed with procedure:To perform QC p.



r To ignore reference range (service only)

1 In data manager, choose the Test Configuration workplace, then choose the Test / reference ranges component.

• Double-click the ACOV2 test.

f The Test / reference ranges dialog box is displayed.

2 In the Workflow group box, select the Ignore validation range check box, then choose the OK button.

• Proceed with procedure:To perform QC p.

r To perform QC

1 Choose QC > Status.

• In the Select column, select the check boxes of the ACOV2 QC material.

• To order QC, choose the Save button.

2 Choose Overview, then choose the Calib. and QC Select button.

f The Calib. and QC Select dialog box is displayed.

3 In the QC group box, choose the Load List Print button.

• Choose the Close button.

f The QC Load List is sent to the print buffer.

4 Choose Print > History.

• In the Report Name column, choose the QC Load List.

I If the QC Load List is not displayed, choose the Refresh button.

f The QC Load List is displayed.

5 Load ACOV2 QC material to the rack positions as indicated in the QC Load List.

6 Perform QC.



r To check QC results

1 Choose QC > Run Status.

• From the Test drop-down list, choose the ACOV2 test.

2 In data manager, choose the QC Routine workplace.

• Choose the QC Routine component.

• In the Test name column, choose the ACOV2 test.

• In the Result Status column, check the result for all ACOV2 controls.

3 Verify that the QC results are within the acceptable range.

• If QC results are out of range, troubleshoot the cause.

• Repeat the QC measurement before measuring samples.

f When calibration and QC are successful, the system is ready for sample measurement.

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