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
Roche Diagnostics Elecsys® 1010 Immunoassay System
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.
PublicationDatePages Affected
Reference No.
Version GammaNov 1996Reference Guide
Software Guide
User’s Guide
Tutorial Guide
Version 1.1May 1997Reference Guide
Software Guide
User’s Guide
Tutorial Guide
Version 2.0Feb 1999Reference Guide
Software Guide
User’s Guide
Tutorial Guide
Version 3.0Jan 2000Reference 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 Guide1
Roche Diagnostics Elecsys® 1010 Immunoassay System
1.Introduction1-1
1.1Manual Outline1-2
1.2The Elecsys 1010 Analyzer1-3
1.3Reagents, Calibrators and Controls1-5
1.3.1Reagent Kits (Reagent Packs)1-6
1.3.2Package Insert1-7
1.3.3Product Information Sheet1-7
1.3.4Calibrator and Control Kits1-7
1.3.5Reagent Bar Code Labels1-8
1.3.6Calibrator and Control Bar Code Labels1-9
1.3.7Calibrator and Control Bar Code Cards1-9
1.4Potential Hazards and Safety Precautions1-10
1.4.1Safety Notes1-10
1.4.2Accident Prevention1-15
1.5Approvals1-17
2.System Description2-1
2.1Introduction2-2
2.2Control Unit2-3
2.3Sample/Reagent Disk2-5
2.4Sample/Reagent Arm2-7
2.5Incubator2-9
2.6Sipper Arm2-10
2.7Liquid System2-11
2.8Measuring Cell2-13
2.9Power Switch2-15
2.10Printer2-15
2.11Floppy Disk Drive2-16
2.12Interfaces2-17
2.13Technical Data2-18
2V 3.0 – Reference Guide
Reference Guide - Table of Contents
3.Functional Sequence of Analysis3-1
3.1Introduction3-2
3.2General Analysis Sequence3-4
3.3Test Sequences3-6
3.3.1Test protocol3-7
3.4Example of an Analysis Process3-8
3.4.1Reagent 1, Reagent 2 and Sample Pipetting3-10
3.4.2First Incubation3-13
3.4.3Resuspension of the Microparticles3-14
3.4.4Microparticle Pipetting3-15
3.4.5Second Incubation3-16
3.4.6Measurement Stage3-17
3.4.7Measurement and Evaluation3-20
3.4.8Measurement Cell Cleaning andPreparation for the Next Measurement3-20
4.
ECL
Technology4-1
4.1
ECL
Technology4-2
5.Test Principles for Immunoassays5-1
5.1Test Principles5-2
5.1.1Competitive Principle5-2
5.1.2Sandwich Principle5-4
5.1.3Bridging Principle5-6
6.Calibration6-1
6.1Introduction6-2
6.2Calibration Concept of Elecsys6-3
6.3Laboratory Calibration6-4
6.4Stability of Calibrations on Elecsys 10106-5
6.5Automatic Validation of Calibrations6-6
6.6Calibration of Quantitative Assays6-9
7.Glossary7-1
V 3.0 – Reference Guide3
Roche Diagnostics Elecsys® 1010 Immunoassay System
4V 3.0 – Reference Guide
1. Introduction
Header
V 3.0 – Reference Guide1 - 1
Roche Diagnostics Elecsys® 1010 Immunoassay System
1.1Manual 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.
Chapter 5. Test Principles
Chapter 6. Calibration
Chapter 7. Glossary
ECL
Technology
This chapter describes the fundamental principle of the electrochemiluminescent
process.
This chapter describes the principles of the various immunoassay processes.
This chapter describes the validation criteria in theory, as well as the various
calibration methods used on Elecsys 1010.
This chapter provides definitions of commonly used terms.
1 - 2V 3.0 – Reference Guide
The Elecsys1010 Analyzer
1.2The Elecsys 1010 Analyzer
The Elecsys 1010 analyzer is a fully automatic, run-oriented analyzer system for
determination of immunological tests using the
e
lectrochemiluminescent 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.
ECL/Origen
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.
V 3.0 – Reference Guide1 - 3
Roche Diagnostics Elecsys® 1010 Immunoassay System
R1/R2S/R probe rinse station
R3Sipper probe rinse station
R4Mixer rinse station
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 - 4V 3.0 – Reference Guide
1.3Reagents, 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.
Reagents, Calibrators and Controls
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).
V 3.0 – Reference Guide1 - 5
Roche Diagnostics Elecsys® 1010 Immunoassay System
1.3.1Reagent 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 - 6V 3.0 – Reference Guide
Reagents, Calibrators and Controls
1.3.2Package 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.
1.3.3Product 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.
1.3.4Calibrator 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).
V 3.0 – Reference Guide1 - 7
Roche Diagnostics Elecsys® 1010 Immunoassay System
1.3.5Reagent 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 Codesand Portable Data Files. Bohemia, NY: Symbol Technologies, Inc; 1992:17-18.
1 - 8V 3.0 – Reference Guide
Reagents, Calibrators and Controls
1.3.6Calibrator 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).
1.3.7Calibrator 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.
V 3.0 – Reference Guide1 - 9
Roche Diagnostics Elecsys® 1010 Immunoassay System
1.4Potential Hazards and Safety Precautions
1.4.1Safety 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 - 10V 3.0 – Reference Guide
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.
V 3.0 – Reference Guide1 - 11
Roche Diagnostics Elecsys® 1010 Immunoassay System
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.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.
1 - 12V 3.0 – Reference Guide
Potential Hazards and Safety Precautions
Additional Precautions
Flammables
Avoid using dangerous flammables near the instrument. Fire or explosion may be
caused by naked flames.
Accuracy/Precision of Measured Results
For proper use of the instrument, measure control samples and monitor the
instrument during operation.
An incorrectly measured result may lead to an error in diagnosis, therefore posing
a danger to the patient.
Application
The instrument is designed for clinical immunological test analysis using watersoluble samples and reagents.
Please note that other analyses may not be applicable to this instrument.
Operator Qualification
1.Operation should be conducted under the management of a technician who
has undergone training at the facility specified by the sales agent.
2.For clinical tests, the instrument should be used under the management of a
doctor or clinical inspector.
Operation and Maintenance
1.During operation and maintenance of the instrument, proceed according to
the instructions and do not touch any parts of the instrument other than those
specified.
2.Do not open the cover while the analyzer is running or operation will be
stopped.
Installation Requirements
Installation is performed by a Roche Diagnostics representative. The customer is
responsible for providing the necessary facilities as detailed in Section 2.13,
Technical Data.
V 3.0 – Reference Guide1 - 13
Roche Diagnostics Elecsys® 1010 Immunoassay System
Restriction on Samples and Reagent Solutions
1.The assay cups, detection unit and liquid waste container are not guaranteed
to be chemically resistant against organic solvents. Therefore, do not use
organic solvents on these parts.
2.Avoid using samples and reagent solutions that are likely to adhere to the
assay tips, assay cups, liquid waste container or detection unit.
Handling Reagent Solutions
Follow the manufacturer’s instructions for use of reagent solutions.
Loading Samples and Reagents
Be sure to load samples and reagents only into the specified positions on the
instrument.
If sample or reagent is spilled, malfunction of the instrument may occur.
Sample/Reagent Disk
Never load new samples onto the sample/reagent disk during the scan process.
When loading the sample/reagent disk, follow the instructions in the manual.
Microparticle Mixer
Be careful not to bend the microparticle mixer. A bent mixer could lead to
inaccurate results.
Switching On the Instrument
After the analyzer has been switched off, wait approximately 10 seconds before
switching it back on.
Instrument Unused for a Long Time
If the instrument will not be used for a long period of time, contact Technical
Support. Different shutdown procedures are recommended depending upon the
duration of inactivity. In addition, certain procedures require the assistance of a
Roche Diagnostics service representative.
1 - 14V 3.0 – Reference Guide
Potential Hazards and Safety Precautions
1.4.2Accident Prevention
Elecsys 1010 is a fully automatic analyzer designed according to the most up-todate safety requirements. This ensures the highest possible protection for the
operator from accidents and ensures correct functioning of the system.
Before using the Elecsys 1010, review the safety precautions described in thischapter to avoid operational interruptions and to protect you from potentialhazards.
The following overview describes specific features for optimal analyzer and
operator protection.
Operator Training
Roche Diagnostics provides system training after which an operator not only
works with the Elecsys 1010 but is also familiar with the relevant safety aspects.
Stand-by Operation and Analyzer Preparation
(Stand-by = the analyzer has power, however, the motion functions of the
individual components are disabled). In Stand-by mode, the tips of the S/R and
sipper probe and the paddle of the microparticle mixer are stowed in their home
positions in the rinse stations. Therefore, the operator cannot be injured by the
probes.
The sample/reagent disk can be removed from the analyzer. Therefore, loading of
samples, reagent packs, calibrators and controls can either be performed on the
analyzer or away from the analyzer.
The consumable containers (CleanCell, ProCell, water and waste containers) are
replaced or refilled in Stand-by mode.
When all the necessary substances have been loaded on the analyzer, the scan
process can be started after closing the cover.
V 3.0 – Reference Guide1 - 15
Roche Diagnostics Elecsys® 1010 Immunoassay System
Analyzer Cover
The analyzer cover must be closed prior to starting a run. A run cannot be started
when the cover is open. If the cover is opened during initialization, the analyzer
stops immediately.
If the cover is opened during a run, the analyzer moves the probes and
microparticle mixer to their home positions in the rinse stations within 2 seconds
to prevent accidental contact. As a result, the run is stopped.
CAUTION
Opening the analyzer cover during a run may cause results to be lost.
STOP
Key
Press the STOP key to stop all operations that Elecsys 1010 is performing as soon
as possible. This process is the same as that described for the analyzer cover.
STAT
Samples
STAT (Short Turn Around Time) samples can be placed on the analyzer in the
designated positions behind the control unit, even when the cover is closed and a
run is being performed. Contact with the probes or microparticle mixer is not
possible. To load STAT samples, the drawer is pulled forward to expose the STAT
positions. There is a mechanical lock present when access is not permitted.
1 - 16V 3.0 – Reference Guide
1.5Approvals
The Elecsys 1010 analyzer was manufactured and tested according to
international standard IEC 1010-1, “Safety requirements for electrical equipment
for measurement, control and laboratory use, Part 1: General requirements”. This
international standard is equivalent to the national standard Underwriters
Laboratories (UL) 3101-1.
The analyzer was tested and approved by the VDE and UL and received the
following safety marks:
Approvals
C
U
®
U
V
D E
L
L
®
¨
geprufte
Sicherheit
Issued by
Association of German Electrical Engineers (VDE).
Issued by Underwriters Laboratories, Inc. (UL).
Issued by Underwriters Laboratories, Inc. for Canada as
a Certification and Testing Organization by the
Standards Council of Canada (SCC).
The analyzer complies with the European Union (EU)
directive 89/336/EEC (Electromagnetic Compatibility).
VDE Testing and Certification Institute,
V 3.0 – Reference Guide1 - 17
Roche Diagnostics Elecsys® 1010 Immunoassay System
1 - 18V 3.0 – Reference Guide
2. System Description
Control Unit
V 3.0 – Reference Guide2 - 1
Roche Diagnostics Elecsys® 1010 Immunoassay System
2.1Introduction
Elecsys 1010 is a fully automated routine and STAT analysis system for the
determination of immunological tests using the ECL/Origen
e
lectrochemiluminescent process. The system measures samples in the form of
serum and plasma. Depending on the test used, the results are produced either
as quantitative or qualitative results.
Elecsys 1010 was designed to be placed on a table. The photograph below
shows where the components for the daily routine are located on the analyzer.
The analyzer has an interface for the connection of a laboratory
An external printer and a PC-compatible keyboard can also be connected.
Water Container
EDP (host) system.
Incubator
Sample/Reagent Disk
Printer/Floppy Disk Drive
ProCell/CleanCell
Waste Container
Control Unit
The system was designed to be powered on and operated 24 hours a day. Power
the analyzer on with the cover down. After configuration run is complete, the
analyzer goes into Stand-by and is ready for operation.
2 - 2V 3.0 – Reference Guide
2.2Control Unit
The control unit is easily accessible from
the front of the analyzer. It is used by the
operator to enter the tasks that the
analyzer is to perform.
The control unit is comprised of a
keyboard, covered by a plastic
protection cover and an
L
iquid Crystal).
Located around the LC display (to the
right and below the display) are
unlabeled keys, called soft keys, which
point to the display. The functions of
these keys change according to the screen displayed.
All keys with a fixed function [to the left (menu keys) and above the display
(function keys)] are labeled accordingly. For example, pressing the SCAN key
initiates a scan of bar code-labeled tubes and reagent packs loaded on the
sample/reagent disk.
LC display (LC =
Control Unit
As an option, a PC-compatible keyboard can be connected for entering text and
special characters. For this purpose, there is a 5-pin standard connector
underneath and to the right of the control unit.
V 3.0 – Reference Guide2 - 3
Roche Diagnostics Elecsys® 1010 Immunoassay System
STAT
Sample Positions
The control unit is designed like a
drawer, which when pulled out
provides access to the two STAT
positions. During a run, up to two
STAT samples at a time can be
loaded in primary tubes or when
using a special adapter (supplied) in
secondary cups.
Normally, access to both STAT
positions is always possible. When
the STAT key is pressed, the
requests for one or both STAT
samples can be entered.
When the STAT requests have been
confirmed, the control unit is locked into
position by the analyzer until all of the
requested tests have been pipetted.
The control unit is then immediately
unlocked so that further STAT samples
can be processed during a run.
Note
A power failure during the pipetting of the STAT samples may lock the control
unit. The locking device can be temporarily overridden by inserting a screwdriver
below the control unit.
2 - 4V 3.0 – Reference Guide
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