Roche LightCycler 480 / 1536 User manual

LightCycler

®

480 LIMS Interface Module

User Guide

Version 3.0

Software Version 1.5

LightCycler® 480 Instrument

Roche Diagnostics

2 LIMS Interface Module – User Guide · 3.0

Publication information

Revision history

Edition notice This publication is intended for users of the LIMS Interface Module.

Every effort has been made to ensure that all the information is correct at the time of

publishing. However, Roche Diagnostics International Ltd reserves the right to make

any changes necessary without notice as part of ongoing product development.

Keep this publication in a safe place to ensure that it is not damaged. This document

should be easily accessible at all times.

CAUTION

General attention

To avoid incorrect results, ensure that you are familiar with the instructions and safety

information.

r Pay particular attention to all safety notices.

r Always follow the instructions in this publication.

r Do not use the software in a way that is not described in this publication.

r Store all publications in a safe and easily retrievable place.

Training Do not carry out operation tasks or maintenance actions unless you have received

training from Roche Diagnostics. Leave tasks that are not described in the user

documentation to trained Roche Service representatives.

Images The screenshots and hardware images in this publication have been added exclusively

for illustration purposes. Configurable and variable data in screenshots, such as

parameters, results, or path names visible therein must not be used for laboratory

purposes.

Warranty Any customer modification to the system renders the warranty or service agreement

null and void.

For conditions of warranty, contact your local sales representative or refer to your

warranty contract partner.

Always leave software updates to a Roche Service representative, or perform such

updates with their assistance.

License information LIMS Interface Module software is protected by contract law, copyright law, and

international treaties. LIMS Interface Module contains a user license between F.

Hoffmann-La Roche Ltd. and a license holder, and only authorized users may access

the software and use it. Unauthorized use and distribution may result in civil and

criminal penalties.

Manual

version

Software

version

Revision date Changes

3.0 1.5 October 2019 LightCycler® 480 LIMS Interface Module Software

Guide and LightCycler® 480 LIMS Module

Programming Reference Manual were combined

in the present publication.

Table 1 Revision history

Roche Diagnostics

LIMS Interface Module – User Guide · 3.0 3

LightCycler® 480 Instrument

Open-source and commercial

software

LIMS Interface Module may include components or modules of commercial or open-

source software. For further information on the intellectual property and other

warnings, as well as licenses pertaining to the software programs included in LIMS

Interface Module, refer to the electronic distribution included with this product.

This open-source and commercial software and LIMS Interface Module as a whole

can constitute a device regulated in accordance with applicable law. For more

detailed information, refer to the corresponding user documentation and labeling.

Note that the respective authorization is no longer valid according to the

corresponding legislation should any unauthorized changes be made to LIMS

Interface Module.

Trademarks The following trademarks are acknowledged:

LIGHTCYCLER and LC are trademarks of Roche.

All other trademarks are the property of their respective owners.

Feedback Every effort has been made to ensure that this publication fulfills the intended

purpose as mentioned above. All feedback on any aspect of this publication is

welcome and will be considered during updates. Please contact your Roche

representative, should you have any such feedback.

Contact addresses

Roche Diagnostics International Ltd

Forrenstrasse 2

6343 Rotkreuz

Switzerland

Made in Switzerland

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

LightCycler® 480 Instrument

Roche Diagnostics

4 LIMS Interface Module – User Guide · 3.0

Roche Diagnostics

LIMS Interface Module – User Guide · 3.0 5

LightCycler® 480 Instrument

Table of contents

Publication information 2

Contact addresses 3

Table of contents 5

Intended use 7

Symbols and abbreviations 7

Safety

1 General safety-related information

Safety classification 13

Safety precautions 14

LIMS Interface Module

2 About the LIMS Interface Module

Introduction 19

Installation of the LIMS Interface Module 21

Interfacing a host and the LIMS Interface

Module 24

Workflow for using the LIMS Interface

Module 26

Retrieving the results of an order 28

Using the internal barcode module 29

3 About the software and debugging

General information and debugging 35

Restrictions and known issues 42

API reference

4Interfaces

Notes 51

ILIMSConnection 52

ILIMSExperimentInfo 60

ILIMSInstrument 65

ILIMSOperationResult 79

ILIMSSampleDefinition 83

ILIMSSampleInfo 92

ILIMSQuery 97

ILIMSQueryResult 103

ILIMSQueryResultData 105

5 Enumerated Types and CoClasses

Enumerated Types 111

CoClasses 112

XML output

6 XML output

Additional details and requirements 119

Output file schema 120

XML-file elements 121

Glossary and index

7 Glossary

Index 131

Roche Diagnostics

6 LIMS Interface Module – User Guide · 3.0

LightCycler® 480 Instrument

Roche Diagnostics

LIMS Interface Module – User Guide · 3.0 7

LightCycler® 480 Instrument

Intended use

u For the intended use statement, refer to the LightCycler

®

480 Instrument Operator’s

Manual, Software Version 1.5.

Symbols and abbreviations

Product names

Except where the context clearly indicates otherwise, this manual uses the following

descriptions:

Symbols used in the publication

Product name Abbreviation

LightCycler

®

480 System

system

LightCycler

®

480 Instrument

instrument

LightCycler® 480 software application software

LightCycler® 480 LIMS Interface Module LIMS, LIMS Interface Module

LightCycler

®

480 System control unit

control unit

Table 2 Product names

Symbol Comment

o List item

P Start of procedure

S End of procedure

U Cross-reference

f Navigation path indication

Q Tip

Safety alert

Electrical and electronic equipment marked with this symbol are

covered by the European directive WEEE.

Table 3 Symbols used in the publication

LightCycler® 480 Instrument

Roche Diagnostics

8 LIMS Interface Module – User Guide · 3.0

Safety

1 General safety-related information ..................................................................................................11

Roche Diagnostics

LIMS Interface Module – User Guide · 3.0 11

LightCycler® 480 Instrument 1 General safety-related information

Table of contents

General safety-related information 1

This chapter contains information about the safe operation of the equipment.

In this chapter

Chapter

1

Safety classification ..............................................................................................................13

Safety precautions.................................................................................................................14

Software and data security............................................................................................14

Roche Diagnostics

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1 General safety-related information LightCycler® 480 Instrument

Table of contents

Roche Diagnostics

LIMS Interface Module – User Guide · 3.0 13

LightCycler® 480 Instrument 1 General safety-related information

Safety classification

This section explains how precautionary information is presented.

The safety precautions are classified according to the ANSI Z535.6 Standard.

Familiarize yourself with the following meanings and icons:

Generic hazard statements

The safety alert symbol by itself without a signal word is used to promote awareness to

hazards which are generic or to direct the reader to safety information provided elsewhere

in the document.

These symbols and signal words are used for specific hazards:

WARNING

Warning

r Indicates a hazardous situation which, if not avoided, could result in death or serious

injury.

CAUTION

Caution

r Indicates a hazardous situation which, if not avoided, could result in minor or moderate

injury.

NOTICE

Notice

r Indicates a hazardous situation which, if not avoided, could result in damage to

equipment.

Important information that is not safety relevant is indicated by the following

symbol:

q

Tip

Indicates additional information on correct use or useful tips.

Roche Diagnostics

14 LIMS Interface Module – User Guide · 3.0

1 General safety-related information LightCycler® 480 Instrument

Safety precautions

Safety information

Before using the LightCycler

®

480 Instrument, read and comply with the safety information

contained in the LightCycler

®

480 Instrument Operator’s Manual.

Software and data security

CAUTION

Unauthorized system access and data loss

External storage devices can transmit computer malware, which may be used to gain

unauthorized access to data or cause unwanted changes to software.

The system is protected against malicious software and hacker attacks from the customer

network by a Roche-provided firewall.

The operators are responsible for the IT security of their IT infrastructure and for protecting

it against malicious software and hacker attacks. Failure to do so may result in data loss or

may render the system unusable.

Roche recommends the following precautions:

r Allow connection only to authorized external devices.

r To protect all external devices, make sure that you use appropriate security software.

r Do not copy or install any software on the system unless it is part of the system

software or your Roche Service representative tells you to do so.

r If extra software is required, contact your Roche Service representative to ensure

validation of the software in question.

r Do not use the USB ports to connect other storage devices unless your Roche Service

representative or an operating instruction tells you to do so.

r Exercise care when you use external storage devices such as USB drives, CDs, or

DVDs. Do not connect to the system any external storage device that you use on public

or home computers.

r Keep all external storage devices in a secure place, and make sure that only authorized

personnel can access them.

r Back up your data regularly.

Disclosure of confidential data due

to entry in the comment field

Adding personal health information of patients to open text fields increases the risk

of privacy incidents and exposure of sensitive data. If you enter confidential data

(such as patient data, test results interpretation, service account credentials) into the

comment field, it can be viewed by unauthorized users.

o Do not enter any confidential patient-relevant information into the comment

field (work order file, result). There is the risk of unauthorized access to patient

data

Disclosure of confidential data due

to patient information being

returned by an optional external

system via the LIMS Interface

Module

Any data not requested in the order query can be recorded in a communication log

file.

o Set up the external system so that it does not return patient information in

addition to the data requested by the system.

LIMS Interface Module

2 About the LIMS Interface Module....................................................................................................17

3 About the software and debugging...................................................................................................33

Roche Diagnostics

LIMS Interface Module – User Guide · 3.0 17

LightCycler® 480 Instrument 2 About the LIMS Interface Module

Table of contents

About the LIMS Interface Module 2

The LIMS Interface Module is an accessory module that enables you to integrate the

system into an in-house Laboratory Information Management System (LIMS)

environment.

In this chapter

Chapter

2

Introduction..........................................................................................................................19

Installation of the LIMS Interface Module .......................................................................21

Interfacing a host and the LIMS Interface Module..........................................................24

Workflow for using the LIMS Interface Module..............................................................26

Preparing the order........................................................................................................26

Starting the experiment.................................................................................................26

Retrieving the results of an order.......................................................................................28

Using the internal barcode module ...................................................................................29

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18 LIMS Interface Module – User Guide · 3.0

2 About the LIMS Interface Module LightCycler® 480 Instrument

Table of contents

Roche Diagnostics

LIMS Interface Module – User Guide · 3.0 19

LightCycler® 480 Instrument 2 About the LIMS Interface Module

Introduction

The LIMS Interface Module software enables the integration of the LightCycler

®

480

Instrument into the software and workflow of a laboratory. It allows you to employ

the system’s internal barcode reader which scans the barcode information on the

multiwell plates, permitting easy assay tracking. It also supports file based data

exchange for experiments, and allows you to start, monitor, and abort experiments

remotely. Furthermore, it allows you to coordinate the loading and unloading of

plates using robotic equipment.

Figure 2-1 Schematic view of the LightCycler

®

480 Instrument integrated into an example workflow via a Laboratory Information

Management System (LIMS)

The LIMS Interface Module is provided with an application programming interface

(API). The API enables interfacing with a laboratory information management

system (LIMS) and facilitates the remote control of the system. Programmers can use

this interface to develop a software application that integrates and coordinates the

system with the laboratory software and data workflow.

u

For further information about the API, refer to API reference (p. 43).

A typical application for the LIMS Interface Module is the integration of the system

into a robotic environment. Such an application could include the following:

o LightCycler

®

480 Instrument with the LIMS Interface Module

o Robot (i.e., a multiwell plate handler) with control software

o Host software which coordinates tasks between the robot and the system

o External hand-held barcode reader (optional) connected to the host software

Roche Diagnostics

20 LIMS Interface Module – User Guide · 3.0

2 About the LIMS Interface Module LightCycler® 480 Instrument

Introduction

Figure 2-2 Illustration of an example LIMS environment

q

Only the instrument, the application software, the LIMS Interface Module, and the

(optional) hand-held barcode reader are provided by Roche.

Via the LIMS Interface Module, the system can be integrated into a laboratory

workflow. An external barcode reader can be connected to the instrument to enter

sample identification information, while the integrated barcode reader enables

recognition of the multiwell plate.

In combination with suitable robotic equipment for plate loading, the LIMS Interface

Module allows the system to start the appropriate experiment template. This

template, called macro, includes the run profile and analysis. The analysis results are

then transferred back into the LIMS Interface Module.

This combination allows the following:

o LIMS-initiated download of test orders

o LIMS-initiated orders for final results

Another typical application for the LIMS Interface Module is the integration of the

system into a non-robotic data environment. Such an application could include the

following:

o LightCycler

®

480 Instrument with the LIMS Interface Module

o Host software which monitors the instrument status

As soon as a multiwell plate is loaded, the host software reads the barcode label and

starts the required experiment. It then exports the experiment from the database to

an XML file.

The following section provides detailed information about the following topics:

o Installation of LIMS Interface Module software

o Interfacing the LIMS Interface Module

o Description of the workflow using the LIMS Interface Module

o Example for programming a “LIMS control program” using the LIMS API

o Reference information for the API

u

For all descriptions and examples necessary for the development of the API and the

driver/adapter, refer to API reference (p. 43).

Application

software

Robot software

Instrument

Robot

(e.g., Twister II

Microplate Handler)

Barcode reader

(optional)

Host software

LIMS Interface

Module

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