Elecsys 1010 Operators Manual Ver 3.0 Jan 2000

© 2000, Roche Diagnostics, a member of the Roche Group. All rights reserved. The contents of this manual, including all graphics and photographs are the property of Roche Diagnostics. Information in this document is subject to change without notice. Roche Diagnostics shall not be liable for technical or editorial errors or omissions contained herein. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of Roche Diagnostics. Elecsys is trademark of a member of the Roche Group. All other trademarks are the property of their respective holders. This manual was created by SCRIPTOR DOKUMENTATIONS SERVICE GmbH, Bielefeld, Germany, on behalf of Roche Diagnostics. Questions/comments regarding the content of this manual can be directed to your local Roche Diagnostics representative.

V 3.0 – Reference Guide

® 1010 Immunoassay System

Roche Diagnostics Elecsys

Revised Manual Pages

Revised pages for this manual are provided by Roche Diagnostics when necessary. No part of this publication may be reproduced in any form or by any means without prior written permission. Publication Reference No.

Date

Pages Affected

Version Gamma

Nov 1996

Reference Guide Software Guide User’s Guide Tutorial Guide

Version 1.1

May 1997

Reference Guide Software Guide User’s Guide Tutorial Guide

Version 2.0

Feb 1999

Reference Guide Software Guide User’s Guide Tutorial Guide

Version 3.0

Jan 2000

Reference Guide Software Guide User’s Guide Tutorial Guide

V 3.0 – Reference Guide

Reference Guide

Reference Guide

Reference Guide - Table of Contents

Table of Contents - Reference Guide

V 3.0 – Reference Guide

1

® 1010 Immunoassay System

Roche Diagnostics Elecsys

1.

Introduction

1-1

1.1

Manual Outline

1-2

1.2

The Elecsys 1010 Analyzer

1-3

1.3

Reagents, Calibrators and Controls

1-5

1.4

1.3.1

Reagent Kits (Reagent Packs)

1-6

1.3.2

Package Insert

1-7

1.3.3

Product Information Sheet

1-7

1.3.4

Calibrator and Control Kits

1-7

1.3.5

Reagent Bar Code Labels

1-8

1.3.6

Calibrator and Control Bar Code Labels

1-9

1.3.7

Calibrator and Control Bar Code Cards

1-9

Potential Hazards and Safety Precautions

1-10

1.4.1

Safety Notes

1-10

1.4.2

Accident Prevention

1-15

1.5

Approvals

1-17

2.

System Description

2-1

2.1

Introduction

2-2

2.2

Control Unit

2-3

2.3

Sample/Reagent Disk

2-5

2.4

Sample/Reagent Arm

2-7

2.5

Incubator

2-9

2.6

Sipper Arm

2-10

2.7

Liquid System

2-11

2.8

Measuring Cell

2-13

2.9

Power Switch

2-15

2.10

Printer

2-15

2.11

Floppy Disk Drive

2-16

2.12

Interfaces

2-17

2.13

Technical Data

2-18

2

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Reference Guide - Table of Contents

3.

Functional Sequence of Analysis

3-1

3.1

Introduction

3-2

3.2

General Analysis Sequence

3-4

Test Sequences

3-6

3.3.1

Test protocol

3-7

Example of an Analysis Process

3-8

3.3

3.4

3.4.1

Reagent 1, Reagent 2 and Sample Pipetting

3-10

3.4.2

First Incubation

3-13

3.4.3

Resuspension of the Microparticles

3-14

3.4.4

Microparticle Pipetting

3-15

3.4.5

Second Incubation

3-16

3.4.6

Measurement Stage

3-17

3.4.7

Measurement and Evaluation

3-20

3.4.8

Measurement Cell Cleaning and Preparation for the Next Measurement

3-20

4.

ECL Technology

4-1

4.1

ECL

Technology

4-2

5.

Test Principles for Immunoassays

5.1

Test Principles

5-2

5.1.1

Competitive Principle

5-2

5.1.2

Sandwich Principle

5-4

5.1.3

Bridging Principle

5-6

5-1

6.

Calibration

6-1

6.1

Introduction

6-2

6.2

Calibration Concept of Elecsys

6-3

6.3

Laboratory Calibration

6-4

6.4

Stability of Calibrations on Elecsys 1010

6-5

6.5

Automatic Validation of Calibrations

6-6

6.6

Calibration of Quantitative Assays

6-9

7.

Glossary

7-1

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® 1010 Immunoassay System

Roche Diagnostics Elecsys

4

V 3.0 – Reference Guide

Header

1. Introduction

V 3.0 – Reference Guide

1-1

® 1010 Immunoassay System

Roche Diagnostics Elecsys

1.1

Manual Outline

The Reference Guide is part of the Elecsys® 1010 Operator’s Manual, which also includes the Software Guide, Tutorial Guide, User’s Guide and Short Guide. The Reference Guide gives a comprehensive insight into the technical/theoretical operation of the Elecsys 1010 analyzer.

Chapter 1. Introduction

This chapter introduces the analyzer and describes the packaging concept for reagents, calibrators and controls. Important safety instructions are also provided in this section. Chapter 2. System Description

This chapter describes in detail the individual components of the analyzer, their tasks and technical data. Chapter 3. Functional Sequence of Analysis

This chapter describes the individual stages of the immunological analysis process on the analyzer. Chapter 4. ECL

Technology

This chapter describes the fundamental principle of the electrochemiluminescent process. Chapter 5. Test Principles

This chapter describes the principles of the various immunoassay processes. Chapter 6. Calibration

This chapter describes the validation criteria in theory, as well as the various calibration methods used on Elecsys 1010. Chapter 7. Glossary

This chapter provides definitions of commonly used terms.

1-2

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The Elecsys 1010 Analyzer

1.2

The Elecsys 1010 Analyzer

The Elecsys 1010 analyzer is a fully automatic, run-oriented analyzer system for determination of immunological tests using the ECL/Origen electrochemiluminescent process. All components and reagents for routine analysis are integrated in or on the analyzer. Operation of the analyzer is simple and intuitive. The reagents are stable and can be directly loaded onto the analyzer. The consistent use of bar-coded reagents greatly reduces the need for time-consuming manual entries in the daily routine. Additional automation can be achieved by connecting a laboratory EDP (host) system.

You can use serum and plasma samples in primary tubes, Hitachi standard cups, microcups or cups on primary sample tubes. Bar-coded sample tubes are recognized. Two STAT positions for STAT samples are also available. Results are produced either qualitatively or quantitatively depending on the test. The typical test throughput is approximately 50 results per hour.

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® 1010 Immunoassay System

Roche Diagnostics Elecsys

Sample/reagent disk
Incubator  Sipper arm   +  Sample/reagent arm (S/R probe and mixer) Detection unit (measuring cell)   +  Positions for ProCell and CleanCell bottles

1-4

R1/R2

S/R probe rinse station

R3

Sipper probe rinse station

R4

Mixer rinse station

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Reagents, Calibrators and Controls

1.3

Reagents, Calibrators and Controls

The reagent packs have a special 2D (two dimensional) bar code, which allows fully automatic registration and management of reagent information. Manual input or additional monitoring is not necessary. The ready-to-use, liquid reagents are loaded into one of the six positions on the sample/reagent disk. Reagents are available for analysis after their bar codes have been scanned.

The handling of calibrators and Roche Diagnostics controls corresponds to that of reagents. Most calibrators are ready-to-use. Lyophilized controls and some calibrators must be prepared and transferred into the appropriate container. Calibrator and control information is stored on 2D bar code cards (see Chapter 1.3.7, Calibrator and Control Bar Code Cards).

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® 1010 Immunoassay System

Roche Diagnostics Elecsys

1.3.1

Reagent Kits (Reagent Packs)

Reagent packs are ready-to-use and incorporate three bottles connected to each other: ●

The white bottle with a transparent lid contains suspended magnetic microparticles that act as the carrier material of the ruthenium-labeled complex during measurement.

●

The black bottle with a gray lid contains R1.

●

The black bottle with a black lid contains R2.

The test application, calibration data, control information, sample and reagent volumes, as well as special measurement conditions are contained in the reagent bar code and therefore do not have to be entered separately by the operator. The following are examples of typical box labels for an Elecsys reagent kit. The large label contains the intended use statement, storage temperature, contents and catalog number of the kit. The smaller side box label contains the lot and expiration date of the kit as well as a bar code number. This bar code number is used for tracking purposes and is not used by the analyzer. Catalog number

Kit lot number

1-6

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Reagents, Calibrators and Controls

1.3.2

Package Insert

Each reagent kit includes a package insert. This insert contains information required to perform the assay. Detailed information is contained in the product information sheet supplied separately.

1.3.3

Product Information Sheet

Each assay applied to this analyzer has a product information sheet that provides general information about the assay. Data contained in the product information sheets is more detailed than what is in the package insert. Instrument settings are encoded in reagent bar codes and not entered by the operator. This type of information, such as sample volume, reagent volume, etc., are found in the overview section of the product information sheet. Product information sheets can be obtained from Roche Diagnostics as required. 1.3.4

Calibrator and Control Kits

In most cases, calibrators and controls for Elecsys reagents come packaged separately. Each kit contains either bar-coded calibrator or bar-coded control vials ready for use on the analyzer. Most calibrators are in ready-to-use liquid form and require no further action other than to place them on the sample/ reagent disk when a calibration is necessary. A few of the calibrators and controls are lyophilized in glass bottles and must be reconstituted before being transferred into plastic bar coded-labeled vials. (Empty bar coded-labeled vials are packaged in these kits with lyophilized calibrators and controls.) Reconstituted calibrators and controls can be stored in the plastic vials after transfer. Calibrators and controls also have color-coded caps to assist you in identification. A white cap is a level one calibrator/control and a black cap is a level two calibrator/control. In the course of the year 2000, black and white color-coded caps for controls will be phased out in favor of beige/light brown (level one) and caramel/dark brown (level two). Calibrator and control bar code cards are packed with calibrator and control kits, respectively (see Chapter 1.3.7, Calibrator and Control Bar Code Cards).

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® 1010 Immunoassay System

Roche Diagnostics Elecsys

1.3.5

Reagent Bar Code Labels

Reagent packs have a bar code label that contains information required to run the assay. This information includes:

●

test number

●

lot number

●

master calibration curve parameters (e.g. Rodbard parameters)



●

instrument settings



●

calibrator lot numbers and target values

●

expiration date

●

calibration frequency

The following information can be identified on each reagent bar code label:
kit catalog number  reagent pack number  reagent bar code number  kit lot number  expiration date.

 

The reagent bar code label is in a new format. The new symbology utilizes portable data files (PDF) and is called PDF417. Traditional linear bar codes serve as a link to a database that contains the appropriate information. PDF417 is a two dimensional (2D), stacked bar code that contains an actual entire data record. The large amount of data that can be encoded allows all instrument settings to be included, as well as the master calibration curve and additional information for the assay. It is from this master curve and from the operator 2-point calibration that the analyzer derives the update of the master calibration curve. For further information, refer to Chapter 6, Calibration. “Every PDF417 symbol (bar code) contains two error detection codewords that are used like the check digit in linear bar code symbologies to detect decode errors and verify that all data have been read and decoded accurately. Additionally, PDF417 provides error correction in the event that portions of symbol have been damaged, destroyed or are unreadable.”1 It is a combination of this error detection and error correction that ensures a reliable bar code. If the bar code cannot be read and the reagent lot has been previously used by the analyzer, the 15-digit number can be entered manually in the software. 1. Itkin S, Martell J. A PDF417 Primer: A Guide to Understanding Second Generation Bar Codes and Portable Data Files. Bohemia, NY: Symbol Technologies, Inc; 1992:17-18.

1-8

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Reagents, Calibrators and Controls

1.3.6

Calibrator and Control Bar Code Labels

Each calibrator and control bottle has a traditional linear bar code label that contains an identifier to link it to information encoded in the reagent bar code label and the calibrator or the control bar code card (see Chapters 1.3.5 and 1.3.7).

1.3.7

Calibrator and Control Bar Code Cards

Each calibrator and control kit comes with one or two 2D bar code cards. The following information is included but not limited to: ●

test number

●

calibrator/control lot number

●

control code (e.g., PCU1) (control card only)

●

lot number of the calibrator/control bar code label

●

information about which calibrator is to be used and the number of determinations (calibrator card only)

●

target values

●

control ranges (control card only)

●

expiration date.

Roche Diagnostics produces a factory master calibration for each calibration lot. The results are encoded into the corresponding reagent bar code. Scan the new bar code card when a new lot of calibrators or controls is used.

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® 1010 Immunoassay System

Roche Diagnostics Elecsys

1.4

Potential Hazards and Safety Precautions

1.4.1

Safety Notes

To protect yourself from potential hazards, you must review all safety precautions and regulations concerning the handling of materials and the system's electrical and mechanical components. The important safety notes in this manual are listed and classified below. Make yourself acquainted with the following visual cues and icons:

$

WARNING Warning messages contain information which, if not followed, could cause serious personal injury and/or damage to the analyzer.

CAUTION Caution messages contain information which, if not observed, could result in loss of data and/or damage to the analyzer.

Note Notes contain important information about a topic in the text.

1 - 10

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Potential Hazards and Safety Precautions

Electricity To avoid an electric shock DO NOT attempt to open the instrument panels and work in any electronic compartment.

Chemical The operator is responsible for taking all necessary precautions against hazard associated with the use of clinical laboratory chemicals. Specific recommendations for each reagent used on the analyzer are found on the box label, package insert or product information sheet for each chemistry. Material Safety Data Sheets (MSDS) are available for Roche Diagnostics reagents. Immediately remove any reagent spillage from the instrument.

Mechanical As with any mechanical system, certain precautions must be taken when operating the instrument. DO NOT wear loose garments or jewelry that could catch in moving mechanisms. DO NOT put your hand into the pathway of any moving parts while the analyzer is operating. Operate the instrument with the cover down. DO NOT attempt mechanical repairs unless the instrument is in Stand-by or OFF.

Biohazardous Materials

As with all in vitro diagnostic equipment, patient samples and serum-based quality control (QC) products that are assayed on this system, as well as all waste from the waste container, should be treated as potentially biohazardous. All materials and mechanical components associated with the sampling and waste system should be handled according to your facility’s biohazard procedure. Use the personal protective equipment recommended by your facility when handling any of these components.

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® 1010 Immunoassay System

Roche Diagnostics Elecsys

Safety Precautions During Operation Samples

1.

Treat all samples as potential biohazards. If sample spills on the instrument, use correct personal protective equipment (PPE-gloves, lab coat, etc.) and wipe off the spillage immediately.

2.

Make sure that the sample does not contain any fibrin, dust or other insoluble contaminants. If insoluble contaminants are contained in the sample, correct measuring values may not be obtained.

Waste Solution and Solid Wastes

1.

Avoid direct contact with waste solution and/or solid wastes. Both should be handled as potential biohazards.

2.

Dispose of waste solution and/or solid wastes according to the relevant governmental regulations.

3.

Consult the reagent manufacturer for information on the concentrations of heavy metals and other toxic constituents in each reagent.

4.

$

WARNING Do not add bleach to the liquid waste container. Bleach combined with the contents of the liquid waste could cause potentially harmful fumes.

Biohazardous Parts

1.

Avoid direct contact with the sample/reagent probe, sipper probe and rinse station. Treat these areas as potentially biohazardous.

Reagents

1 - 12

1.

Avoid direct contact with reagents. Direct contact may result in skin irritation or damage. Refer to the reagent kit box labels or package insert for specific instructions.

2.

Avoid direct contact with CleanCell. Direct contact may result in skin irritation or damage. Refer to the CleanCell box label or package insert for specific instructions.

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