cobas 4000 analyzer series - Rocherpd-e-learning.roche.com/Elecsys_Anti-SARS-CoV-2...Roche Diagnostics cobas® 4000 analyzer series · Publication version 1.0 · Test Installation

cobas® 4000 analyzer series<cobas e 411 analyzer>Test Installation Guide - Elecsys® Anti-SARS-CoV-2

Roche Diagnosticscobas® 4000 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 the cobas e 411 analyzer 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 / User Assistance contains all information about the product.

Operator Only trained staff is able to work safely with the cobas e 411 analyzer. 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 Manual of the cobas e 411 analyzer.

For their own safety, operators of the cobas e 411 analyzer 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 calibrators and calibrator values appear after loading the ACOV2 reagent pack. It is not necessary to scan the Calibrator Barcode card or to download separately from cobas link.

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

d m ACOV2 reagent pack at room temperature:20 °C ± 2 °C (68 °F ± 5,4 °F)

m Method Sheet

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

j • Reference data file v4.15 (SN-CPS-2020-048) is installed.

• The system is in Stand By mode.

• You are logged on as administrator.

r To verify the reference data file installation

1 Choose the Help button.

f The Online Help / User Assistance is displayed.

2 In the table of contents, choose Publication Information > System Information.

• Verify that reference data file v4.15 (SN-CPS-2020-048) is installed.

r To verify ACOV2 application parameters

1 Ensure that the ACOV2 reagent pack is at room temperature.

I Room temperature is 20 °C ± 2 °C (68 °F ± 5,4 °F).

2 Load the ACOV2 reagent pack.


Installing Elecsys® Anti-SARS-CoV-2 5

3 Choose Reagent, then choose the Reagent Scan button.

f The ACOV2 reagent pack is displayed in the table.

4 Choose Utility > Application > Analyze.

• In the Test column, choose the ACOV2 test.

• From the Default Dilution Ratio drop-down list, choose the 1 option.

• Choose the Save button.

5 Choose Utility > Application > Calib..• In the Daily Calibration group box, choose the

Off button.

• In the QC Violation group box, enable the setting if required.

• In the Auto Masking group box, choose the On button.


6 Choose Utility > Application > Range.

• If required, change the settings.




r To perform calibration

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

• In the Method group box, choose the Full button.

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, then choose the Calibration tab.

f The Calibration screen is displayed.

2 From the Calibration Items column, choose the Calibration Result report.

• Choose the Print button.

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

3 Choose the Close button.

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 Choose QC > Install.• In the Control column, choose an empty row.

• Choose the Add button.

f The Add Control dialog box is displayed.

2 Perform the following actions:

• In the Control field, enter the name of the QC material (up to 10 characters).

• From the Sample Type drop-down list, choose the Ser/Pl option.

• From the Control Code. drop-down list, choose any option between 64-78.

• In the Control Lot No. field, enter the lot of the QC material (up to 8 characters).

• In the Expiration Date field, enter the year (yyyy) in the first field. Enter the month (mm) in the second field.

3 Choose the OK button.

f The QC material is displayed in the Control column.

4 In the Control column, choose the installed QC material

• Choose the Edit button.

f The Test Assign dialog box is displayed.

5 In the Available Tests column, choose the ACOV2 test.

• Choose the Assign >>> button.

• To assign the ACOV2 test, choose the OK button.

f The Edit Control dialog box is displayed.



6 In the Test column, choose the ACOV2 test.

7 In the Individual group box and Cumulative group box, enter the following fields as required:

• T.Mean• T.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.

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

f The Install screen is displayed.

9 In the Control column, choose the installed QC material.

• In the Test column, choose the ACOV2 test.

• Choose the Activate Test button.

10 Repeat steps 1 to 9 for the second level of QC.

r To assign ACOV2 QC material to rack or disk positions

1 Choose QC > Control, then choose the Position Assignment button

f The Position Assignment dialog box is displayed.

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

• In the Position column, choose an empty position.

• Choose the Assign >>> button.

• Repeat step 2 for the second level of QC.

I The position can be on a rack or disk.




r To perform QC

1 Choose QC > Status.

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

• To order QC, choose the Select button.

f In the Selection column, the ACOV2 QC material is highlighted in teal.

2 Choose the Save button.

3 From the System Overview window, choose the Calib/QC Load List button.

f The Calib/QC Load List dialog box is displayed.


f The Calib/QC Load List is printed.

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

I Place ACOV2 QC material on suitable sample containers (e.g. Hitachi Cups).

6 Perform QC.

r To check QC results

1 Choose QC > Run Status.

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

2 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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