01 - S 201 - CST - Cobas S 201 System Overview - V1.0

cobas s 201 system
cobas s 201 system Overview

Objectives
Upon completing this section, the trainee should be able to describe:
• Hardware Components
• Functionality of Roche PDM (Pooling and Data Management) Software
• Pooling Methods and Combinations
cobas s 201 CST Global Customer Support cobas s 201 System Overview
Nov. 2015 – Version 1.0 Page 2
Intended Use
• Screening of infectious agents in
human plasma
• Plasma can be tested individually or

in pools composed of equal aliquots
* Note: Magnetic glass particle (MGP)

nucleic acid extraction
technology
* Note: Polymerase chain reaction

(PCR)
amplification technology
* Note: 5’ nuclease real-time detection

(TaqMan®) technology
Major Processing Steps
Individual Donor Tubes
• Pooling or Manual Pipetting
• Sample preparation Pooling Management

Workstation
• Amplification and detection Hamilton Microlab STAR IVD /

STARlet IVD Pipettor
• Result review and

management.
PDM server - pooling COBAS® TaqMan® analyzer
and result data stored
* Note: Donor samples are COBAS® AmpliPrep instrument
processed in batches:
A set of samples and
controls
that are pipetted, AmpliLink
extracted, Workstation Sample Preparation Amplification & Detection
Data Management
amplified, and detected Workstation
together.
Main Features (I)
• Scalable, flexible, and modular design
• Configurable:
- Multiple pooling methods
- Variable donor tube size
- User Defined External Controls (UDEC)
- Multi-assay handling capability (MPX, WNV or DPX)
- Library Plate creation (Primary Pooling only for Pools of 1 and 6)
- Library Plate use (Secondary Pooling only for Pools of 1 and 6)
• Full system sample tracking
• System-guided pooling interface
Main Features (II)
• System surveillance of liquid handling, temperatures, disposables, reagent
status, waste, and maintenance schedule
• Automatic/manual data archiving and database backups
• Fully automated sample pooling and archiving
• Ready-to-use reagents
• Continuous loading capability for PCR testing
Hardware Components Laboratory Information
system
cobas IT firewall
Overview PDM Server
• PDM server connections: Printer
– Instrument/station network
– Optional laboratory Hamilton MICROLAB
STAR
Pooling
Management
Workstation
Data Management
Workstation
IVD pipettor
information system (LIS) Server Backup
Kit
• Pipettor-Instrument-Analyzer
configurations:
Data station for
- Minimum = 1-1-1 AMPLILINK
software
- Maximum = 12-30-20
Instrumentation
hub
* Note: The configuration with

3 AmpliPreps and 2
TaqMans
COBAS® AmpliPrep instrument
can have two Docking Docking Station COBAS® TaqMan®
analyzer
cobasStations.
s 201 CST Global Customer Support cobas s 201 System Overview
Hardware Components
Hamilton Microlab® STAR IVD / STARlet IVD
Pipettor
• Donor sample pooling
• Control pipetting
• Library Plate creation (optional)
• Local database for Pooling: if connection to

Server is lost the Pooling run can be finished
Hardware Components
COBAS® AmpliPrep Instrument
• Nucleic acid extraction using

magnetic glass particle (MGP)
technology
Hardware Components
COBAS® TaqMan® Analyzer
• PCR amplification
• 5’ nuclease real-time detection technology
Hardware Components
PDM Server Bundle
• PDM server hard disks
• 24-port gigabit network switch
• Uninterruptible power supply (UPS)
• Lockable server rack
Hardware Components
Pooling Management Workstation
• Operate the pipettor
• View and manage pooling results
• Shut down and power on at the start of the

work day
* Note: Equipped with a handheld barcode

scanner
Hardware Components
Data Management Workstation
• View and manage pooling results
• Review and manage PCR results
• Send results to the LIS
• Configure system options
• Administrate users
• Create reports
• Archive data and create database backups

• Shut down and power on at the start of the work day
Hardware Components
Data Station for AMPLILINK Software
• Operate the COBAS® AmpliPrep

Instrument
• Operate the COBAS® TaqMan® Analyzer
• Automatic transfer PCR data to the PDM

server
• Shut down and power on daily
* Note: Equipped with a handheld barcode

scanner.
Hardware Components
Server Backup Kit
• HP StorageWorks® SDLT 600 tape drive
• Connected to a Data Management
Workstation
Network Printer
• Required for the printing of PDM reports
* Note: The Hewlett Packard 2055N is a
validated
example.
Hardware Components
Checking Communication
• Check the communication status between the workstations and the server on
the workstation taskbar
• Display the taskbar using the Windows® ® key of the keyboard
• If the database is not available, shut down and power on the workstation
Roche PDM Software
Application Overview
• PDM Pooling Wizard
• PDM Pooling Manager
• PDM Data Manager
• Report Manager
• User Administration
• PDM Configuration
• Archive Management
Roche PDM Software
Login Service
• Displayed whenever
workstations are powered on
• Accounts are disabled after too

many failed attempts
Roche PDM Software
Notification of Critical
Alarms
• Displayed after login if

system-related alarms
exist
• Cannot be closed until all

alarms are acknowledged
• Operations can be
performed with the dialog
box open
* Note: An auditable alarm

is
given
Roche PDM Software
Electronic Signature
• Required whenever a record is

added, modified, or deleted
* Examples:
- Adding a new user
- Rejecting a pool
- Force Release a SK24 rack
- Force Unresolve a donor
- Configuring system settings, etc
Roche PDM Software
Screen Layout
• Title Bar
• Status Area
• Navigation Tabs
• Work Area
• Local Command Buttons
• Global Command Buttons
* Note: Windows® functions

are
blocked.
Roche PDM Software
Global Command Buttons
PDM Pooling Wizard Configuration Manager
PDM Pooling Manager

Logoff
PDM Data Manager

Button text gray: Not available
to the logged-in user.
Report Manager
User Administration Application
Pooling Methods and Combinations
One-step Pooling
• Primary Pools of 1
Pooling S-tube
• Short Run Pools (Pools of 48) 1, 6, 24, 48 donor tubes
• Simultaneous Pools (6 MPX and 6 WNV) or (6 MPX and 1 WNV)
* Note: For all configured Pool sizes Primary Pools of 1 is automatically

configured.
* Note: Once configured, the pools size per assay should not be changed.
Two-step Pooling
1. Step: Plate Run 2. Step:
Batch Run
* Note: Pool sizes Primary Pools of 1 is automatically configured.

* Note: Once configured, the pools size per assay should not be changed.
Version History
Version Date Modifications
1.0 November 2015 Complete revision of presentation due to new

training
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cobas s 201 system

cobas s 201 system Overview

• Functionality of Roche PDM (Pooling and Data Management) Software

• Pooling Methods and Combinations

• Plasma can be tested individually or

* Note: Magnetic glass particle (MGP)

* Note: Polymerase chain reaction

* Note: 5’ nuclease real-time detection

• Pooling or Manual Pipetting

• Sample preparation Pooling Management

• Amplification and detection Hamilton Microlab STAR IVD /

• Result review and

Overview PDM Server

• PDM server connections: Printer

* Note: The configuration with

• Donor sample pooling

• Library Plate creation (optional)

• Local database for Pooling: if connection to

• Nucleic acid extraction using

• 5’ nuclease real-time detection technology

• Operate the pipettor

• View and manage pooling results

• Shut down and power on at the start of the

* Note: Equipped with a handheld barcode

• View and manage pooling results

• Review and manage PCR results

• Send results to the LIS

• Configure system options

• Archive data and create database backups

• Operate the COBAS® AmpliPrep

• Operate the COBAS® TaqMan® Analyzer

• Automatic transfer PCR data to the PDM

• Shut down and power on daily

* Note: Equipped with a handheld barcode

• Display the taskbar using the Windows® ® key of the keyboard

• PDM Pooling Wizard

• PDM Pooling Manager

• PDM Data Manager

• Accounts are disabled after too

• Displayed after login if

• Cannot be closed until all

* Note: An auditable alarm

• Required whenever a record is

• Local Command Buttons

• Global Command Buttons

* Note: Windows® functions

PDM Pooling Wizard Configuration Manager

PDM Pooling Manager

PDM Data Manager

User Administration Application

• Simultaneous Pools (6 MPX and 6 WNV) or (6 MPX and 1 WNV)

* Note: For all configured Pool sizes Primary Pools of 1 is automatically

* Note: Pool sizes Primary Pools of 1 is automatically configured.

Version Date Modifications

1.0 November 2015 Complete revision of presentation due to new

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