cobas 6000 analyzer series - Rocherpd-e-learning.roche.com/Elecsys_Anti-SARS-CoV-2... · cobas® 6000 analyzer series · Publication version 1.0 · Test Installation Guide - Elecsys®

cobas® 6000 analyzer series

Test Installation Guide - Elecsys® Anti-SARS-CoV-2

Roche Diagnosticscobas® 6000 analyzer series · Publication version 1.0 · Test Installation Guide - Elecsys® Anti-SARS-CoV-2 ·

2

Publication information

Edition notice This Test Installation Guide supplements the

Operator’s Manual of cobas® 6000 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® 6000 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 Operator’s

Manual of cobas® 6000 analyzer series.

For their own safety, operators of cobas® 6000 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


3

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 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 Sheetm Short Guide: Preparation of Quality Control materials

for use in Elecsys Anti-SARS-CoV-2

m Diluent MultiAssay

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. • 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 Code option.• From the Application Code drop-down list,

choose the ACOV2 application code: 737.

I Alternatively, choose the Application Name option, then choose the ACOV2 test.

3 Choose the Search button.f The ACOV2 test is displayed in the table.


Installing Elecsys® Anti-SARS-CoV-2 5

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.

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

• Choose the Download button.• To confirm the file transfer, choose the OK button.f The Confirmation dialog box is displayed.

6 Review the displayed information.• Choose the OK button.f The ACOV2 test is downloaded and automatically

assigned to all available modules and measuring cells.

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

r To assign ACOV2 test to a test key

1 Choose Utility > System (Page 1/4) then choose the Key Setting button.f The Key Setting dialog box is displayed.

2 Choose an empty test key.f The Key Setting dialog box for the test key is

displayed.



3 In the Test and Profile table, choose the ACOV2 test.• Choose the OK button.f The Key Setting dialog box is displayed.

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

r To define ACOV2 test assignment

1 Choose Utility > Module Set, then choose the Test Assignment button.f The Test Assignment dialog box is displayed.

2 Choose the e 601 module.f The e601 Test Assignment(E Module) dialog

box 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 is displayed.

5 If an additional e 601 module 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 (Page 2/4), then choose the Reagent Level button.f The Reagent Level Check dialog box is

displayed.

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

• Choose the ACOV2 test.

• Select the Activate Alarm check box.• In the Tests field, enter the number of remaining

determinations.

• Choose the Check Update button.I Recommendation:

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

4 Choose the OK button.

r To verify special wash list

1 Choose Utility > Special Wash, then choose the Immune tab.• Verify that the special wash list is up-to-date.

r To load ACOV2 reagent pack

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.• Ensure that Diluent MultiAssay is placed on the

analyzer.



3 Choose Reagent > Setting.• From the Module drop-down list, choose the

e 601 module.• Verify that the ACOV2 test is listed in the Test

column.

r To perform calibration

1 Choose Calibration > Status• In the Test Name column, choose the ACOV2 test.• In the Method group box, 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 Workplace, then choose the Calib. Review tab.

f The Calib. Review screen is displayed.

2 In the Status column, verify that S is displayed to indicate a successful calibration.

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 Choose QC > Install.• In the Control table, 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.

• In the Material No. field, enter any available number between 801-999.

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

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

3 Choose the OK button.I If an input error message is displayed, choose

another number in the Material No. field.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 Edit Control dialog box is displayed.

5 In the Test column, choose the ACOV2 test.

6 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.



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

f The Install screen is displayed.

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

• In the Test column, choose the ACOV2 test.• Choose the Activate Test button.

9 Repeat steps 1 to 8 for the second level of QC.

r To assign ACOV2 QC material to rack positions

1 Choose QC > Control, then choose the Rack Assignment button.f The Rack Assignment dialog box is displayed.

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

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

• Choose the Add --> button.• Repeat step 2 for the second level of QC.

3 Choose the OK button.

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 Calibration and QC Select button.f The Calibration and QC Select dialog box is

displayed.



4 In the Load List group box, choose the QC option.• Choose the Print button.f The QC Load List is printed.

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 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.



cobas® 6000 analyzer seriesPublication informationContact addressesInstalling Elecsys® Anti-SARS-CoV-2

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