r
cobas® 4800 system Host Interface Manual Software Version 1.02 DRAFT
cobas® 4800 system
Host interface Manual
Table of Contents General
1
Target audience.................................................................................... 1 References
.................................................................................... 1
.................................................................................... 1 Document Revision History .................................................................................... 2 Contacts, Trademarks Glossary
.................................................................................... 3
Overview
4
.................................................................................... 4 Communication Overview .................................................................................... 5 Communication layers
Workflow
6
.................................................................................... 6 Communication Scenarios .................................................................................... 6 Work Order Inquiry Result export .................................................................................... 8
Message types
8
.................................................................................... 8 General Information .................................................................................... 8 Full Run Inquiry .................................................................................... 8 Full Order Response .................................................................................... 10 Test Result Export FLAGS
.................................................................................... 13
Test Result Export workflow
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Host interface Manual
cobas® 4800 system
ASTM Protocol
17
19 COBAS 4800 .................................................................................... ASTM Record Definitions .................................................................................... 20 Inquiry records Mappings (ASTM) H Segment.................................................................................... 20 P Segment .................................................................................... 21 Q Segment.................................................................................... 21 L Segment .................................................................................... 21 .................................................................................... 22 Inquiry Response Mapping H Segment.................................................................................... 22 P Segment .................................................................................... 23 O Segment.................................................................................... 23 L Segment .................................................................................... 24 Inquiry/response examples .................................................................................... 25 .................................................................................... 26 Results Mapping (ASTM) H Segment.................................................................................... 26 P Segment .................................................................................... 27 O Segment.................................................................................... 27 R Segment .................................................................................... 28 L Segment .................................................................................... 28 .................................................................................... 29 Results Example ASTM
HL7 Protocol
31
32 COBAS 4800 .................................................................................... HL7 Record Definitions .................................................................................... 33 Inquiry Records mapping (HL7) Inquiry Mapping .................................................................................... 33 Inquiry Response Mapping .................................................................................... 35 .................................................................................... 37 Results Mapping (HL7) Result Example HL7 .................................................................................... 40
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Communication setup
42
.................................................................................... 42 Network connection .................................................................................... 42 Instrument Setup
Simulator
43
.................................................................................... 43 Installing simulators .................................................................................... 43 HL7 Simulator Setting up the simulator connection .................................................................................... 46 Connection.................................................................................... test 49 Sending an.................................................................................... order to the system 50 Receiving results from the system. .................................................................................... 54 .................................................................................... 57 ASTM Simulator
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Troubleshooting / logfiles
58
Known restrictions
58
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Host interface Manual General
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cobas® 4800 system
General
Target audience The intended audience for this manual is Host Interface programmers and the Roche Field engineers supporting the system.
References [1] HL 7 Documentation Version 2.4, Health Level Seven, Ann Arbor MI, USA, www.HL7.org [2] ASTM Documentation 1394 LIS2 Note:
Although ASTM and HL7 are the base of the data exchange, the result transmission is not a strict ASTM or HL7 format. The system presents CT/NG or HPV as global blocks of results and transmits them as such.
See the Result topics for the respective ASTM and HL7 formats for details.
Document Revision History Document Version
Revision Date
1.0
January 2009
1.02 Manual rev 02
March 2010
Copyright 2009, 2010, Roche Diagnostics Ltd. All rights reserved. Rev 02:
Corrected some errors and omissions. Clarified the target audience of manual and simulators. Added definition Client / server. Added complete results fields tables Added examples multiple flags Added information regarding media types Added information regarding order handling (Tubes without orders) at various places. Timeout for order response from LIS increased to 180 seconds.
This manual applies to Software Version 1.02 Information in this document is subject to change without notice. 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 GmbH. Every effort has been made to ensure that all the information contained in this manual is correct at the time of publishing. However, Roche Diagnostics Ltd. reserves the right to make any changes necessary without notice as part of ongoing product development.
Document references These are internal Roche references DVS Number: 05702950001 Material Number: 10330010
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Host interface Manual General
Contacts, Trademarks Contact Addresses Manufacturer
Roche Diagnostics Ltd. Forrenstrasse CH-6343 Rotkreuz Switzerland
Distribution
Roche Diagnostics GmbH Sandhofer Straße 116 D-68305 Mannheim Germany
Distribution in the US
Roche Diagnostics 9115 Hague Road PO Box 50457 Indianapolis, IN 46250 USA
Questions or comments regarding the contents of this manual can be directed to the address below or to your Roche representative. Roche Diagnostics Ltd. Global Service Support Forrenstrasse 6343 Rotkreuz, Switzerland email:
[email protected]
Trademarks cobas is a trademark of Roche. Other brands or product names are trademarks of their respective holders.
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Host interface Manual General
cobas® 4800 system
Glossary
MTS
Medium Throughput System This name is sometimes used inside the protocol. Where the Acronym MTS is used, it means the cobas ®4800 system..
A&D
Amplification and detection. The system will only perform Amplification and detection on already prepared MWP, using the z 480 instrument. The A&D runs are not supported by the LIS workflow.
AnD
Same meaning as A&D - Often used inside records as the "&" character would be interpreted as separator and therefore cannot be used.
Full run
Samples will be prepared into a MWP by the cobas x 480, then the plate will be transferred manually to the cobas z 480 for the A&D run.
GUID
Stands for Global Unique Identifier. A unique identifier created by the system. It is a 128 bits number written in a pattern of hexadecimal numbers similar to : 3F2504E0-4F89-11D3-9A0C-0305E82C3301 It is used to identify a unique run in the transmission records.
MWP
Microwell plates.
Transformer
A software module that conforms XML communication files to the communication server.
cobas x 480 instrument
The cobas x 480 prepares the samples. The cobas x 480 is loaded with samples, consumables and reagents. After sample preparation, the multiwell plate with the PCR-ready samples is unloaded, sealed, and transferred to the cobas z 480 for amplification and detection.
cobas z 480 analyzer
The cobas z 480 utilizes fluorescence to detect nucleic acids amplified by using realtime PCR methodology. the loading and unloading of the multiwell plate is done manually.
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Host interface Manual General
2
Overview
The structure of the document is as follow The topic General describes general functions of the subsystem or the unit having influence on the implementation. This chapter contains no specifications but provides background information and context information for the specifications stated in the next chapter. The goal is to increase the legibility of the document. Topic HL7 contains all the specifications for the HL7 protocol. Topic ASTM contains all the specifications for the ASTM protocol.
Communication Overview The physical connection used by the cobas 4800 host interface is the standard network card (N.I.C) with Ethernet protocol. The connection is TPC/IP over ethernet. The RS-232 connection is not supported by the system. The cobas 4800 system offers two transmission protocols:
-ASTM -HL 7
The communication is realized by xml files which are exchanged and evaluated between cobas 4800 sw Transformer and Transformer cobas 5000 IT Communications Server.
Client /Server structure The communication is always established by the cobas 4800 control unit; the cobas 4800 system is always the TCP/IP client and the LIS is always the TCP/IP server.
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Host interface Manual Overview
cobas® 4800 system
Communication layers As all the communication is based on network connections, this manual addresses mostly the upper layer (application) related topics. This layer corresponds to the upper layer in the well known OSI model:
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3
Workflow
Communication Scenarios The following table shows the communication scenarios existing for the cobas 4800. Table 1 Communications Scenarios Name
Description
Input
Output
Work Order Inquiry Full
The cobas 4800 ask the LIS to get order details for one or more Samples
Run Type, Test Type, Sample Id’s
For each sample: Sub Test Type, Media Type
Work Order Inquiry A&D Only
This mode is not supported Run Type, Test Type, Id of the by the LIS workflow MWP
For each sample: Sub Test Type, Media Type, MWP Position
Test Result Upload
The cobas 4800 System Run Id, Run Type, Test Type sends the test result of a Run Sub Test Type, Media Type, to the LIS Test Result, Flags, Sample Id, Test Time Stamp, Order Time Stamp, Accepted Flag
-
Once the LIS has been enable by Roche support, the LIS must always respond to order requests. There is no possibility to work with "results sending only" and manually ordering. If the LIS cannot respond to order requests, the system cannot run tests unless the LIS is disabled again to work completely offline.
Work Order Inquiry
Figure 1 Work Order Inquiry The Work Order Inquiry Scenario is described In Figure 1. If a cobas 4800 user starts a run to test samples it loads the samples or the MWP plate. After the plate loading, the cobas 4800 system starts the above inquiry sequence to the LIS server.
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Missing orders: When sample numbers are received that do not have a corresponding test request in the Host system, the whole sample record must be skipped. No "empty" orders shall be sent to the cobas 4800, otherwise it will result into a complete order upload failure. See in Each protocol for details. When order numbers are skipped, the mismatch will be signaled on the screen as shown below (1): (Mismatch occurred between loaded and expected samples Please press "Unload Sample" ) The sample positions are indicated in (2)
Possible correcting actions : 1. Unload the sample rack(s), remove the indicated sample tubes (2), reload the sample rack. or 2. Unload the sample rack, add orders to the indicated samples into the LIS system, reload the sample rack(s)
Work order inquiry timeout: The timeout after a work order inquiry from the instrument is currently set at 180 seconds and cannot be changed. The complete work order list has to be completely transmitted within these 180 seconds, otherwise a timeout message will result.
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Host interface Manual Workflow
Result export The results can be manually exported to the LIS using the selected protocol (ASTM or HL7). The LIS has to be enabled to be able to export the results. If the system works in offline mode and tests are ordered manually , results cannot be exported via LIS. The total transmission time should not exceed 120 seconds otherwise the last results may not be transmitted.
4
Message types
General Information The Full run, the A&D Only run and the result export have different data to transfer. The following tables show the detail of this data.
Full Run Inquiry Table 2 Full Run Inquiry cobas 4800 Query
Example
HL7-Mapping
ASTM-Mapping
Run Type
Full
QPD-3-2
Q-5-6
Test Type
CT/NG
QPD-3-1
Q-5-4
Software
MTS
MSH-3
H-5-3
Version
0.9.1.0843
MSH-4
H-5-4
Sample Id’s (1-94)
100101001
QPD-4
Q-3
Full Order Response Table 3 Full Order Response cobas 4800 Query
Example
HL7-Mapping
ASTM-Mapping
Run Type
Full
OBR-4-3
O-5-6
Test Type
CT/NG
OBR-4-1
O-5-4
Software
LIS
MSH-3-1
H-5-3
Version
6.3
MSH-4-1
H-5-4
Sample Id
0010212
OBR-3-1
O-3-1
SubTestType
NG
OBR-4-2
O-5-5
Media Type
UT
OBR-15
O-16
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Table 4 Possible values SubTestType (order response) Type
Possible values for subtype field (order response)
CT/NG
CT/NG CT NG
HPV
HPV High Risk Panel + Genotyping HPV High Risk Panel
Table 5 * Possible values media Type
Test subtype
Possible value field Media Type
CT/NG
CT
UT UUT
= UniTrans = Urine UniTrans
PC SP
= PreserveCyt = SurePath original tube is not validated on cobas 4800
NG
Media names
CT/NG HPV
HPV High Risk Panel HPV16 HPV18
Roche Diagnostics Host Interface manual
PC and SP are used, whether the samples are in original containers or in secondary tube round base 13mL
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Test Result Export Table 6 Test Result Export Test Result Export
Example
HL7 Mapping
ASTM Mapping
Start Time
2008-10-14T13:49:39
OBR-7
R-12
End Time
2008-10-14T13:50:45
OBR-8
R-13
Test Type
CT/NG
OBR-4
R-3
Run Type
Full
OBR-4
O-4
Run Id
83b6f32c-d31b-49a8-8239-13be65486ea3
MSH-10
O-4;H-5-1
User Id
Laboperator
OBX-16
R-11
Software
MTS
MSH-3
H-5-3
Version
0.9.3.0847
MSH-4
H-5-4
Created
Admin
ORC-10
O-17
Creation Date
2008-06-11T15:56:58
ORC-7-4
O-8
Plate Id (A&D Only)
AD000012
OBX-3;OBR-3
O-3;H-5
Examples: Invalid ; CT POS, NG POS ;
OBX-5-1
R-4-1
For each Sample Test Result
See Test results combination for all possibilities.
11
tables
Flag Pattern
M1,M3
OBX-5-2
R-4-2
Sub Test Type
CT
OBR-4
R-3
Sample Id
100101001
OBX-3;OBR-3
O-3;H-5
Media Type
UUT
OBR-15
O-16
Order Date
2008-10-14T13:50:38
OBR-27
O-15
Accepted Flag
False
OBX-11
O-26
MWP Position
A5
OBX-3;OBR-3
O-3;H-5
Test result Possible values (Samples) invalid
positive (POS)
negative (NEG)
Test result Possible values (Controls) invalid
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Test results combination tables : Table 7 cobas® 4800 CT/NG Test
Result Report and Interpretation
CT POS, NG POS
CT Positive, NG Positive. Specimen is positive for the presence of both CT and NG DNA.
CT NEG, NG NEG
CT Negative*, NG Negative*. Neither CT nor NG DNA, if present, could be detected.
CT POS, NG NEG
CT Positive, NG Negative*. Specimen is positive for the presence of CT DNA. NG DNA, if present, could not be detected.
CT POS, NG Invalid
CT Positive, NG Invalid. Specimen is positive for the presence of CT DNA. NG result is Invalid. Original specimen should be re-tested to obtain valid NG result.
CT NEG, NG POS
CT Negative*, NG Positive. CT DNA, if present, could not be detected. Specimen is positive for the presence of NG DNA. CT Invalid, NG Positive.
CT Invalid, NG POS
CT result is Invalid. Original specimen should be re-tested to obtain valid CT result. Specimen is positive for the presence of NG DNA.
CT Invalid, NG NEG
CT Invalid, NG Negative*. CT result is Invalid. Original specimen should be re-tested to obtain valid CT results. NG DNA, if present, could not be detected.
CT NEG, NG Invalid
CT Negative*, NG Invalid. CT DNA, if present, could not be detected. NG result is Invalid. Original specimen should be re-tested to obtain valid NG result.
Invalid
CT Invalid, NG Invalid. Both CT and NG results are Invalid. Original specimen should be re-tested to obtain valid CT and NG results.
Failed
No Result for Specimen Consult the cobas® 4800 system Operator’s Manual for instructions to review run flags and recommended actions. Original specimen should be re-tested to obtain valid CT and NG results.
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Table 8 cobas® 4800 HPV Test
Result Report and Interpretation
SubTest “HPV High Risk Panel”: HR HPV POS
High Risk HPV Positive Specimen is positive for the DNA of any one of, or combination of, the following high risk HPV types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68.
HR HPV NEG
High Risk HPV Negative* HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNA were undetectable or below the pre-set threshold.
Invalid Failed
High Risk HPV Invalid Results are invalid. Original specimen should be re-tested to obtain valid result. No Result for Specimen Consult the cobas® 4800 system Operator’s Manual for instructions to review run flags and recommended actions. Original specimen should be re-tested to obtain valid result.
SubTest “HPV High Risk Panel Plus Genotyping”: Other HR HPV POS, HPV16 POS, HPV18 POS
Other High Risk HPV Positive, HPV16 Positive, HPV18 Positive. Specimen is positive for HPV types 16 and 18 DNA and the DNA of any one of, or combination of, the following high risk HPV types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68.
Other HR HPV POS, HPV16 POS, HPV18 NEG
Other High Risk HPV Positive, HPV16 Positive, HPV18 Negative*. Specimen is positive for HPV type 16 DNA and the DNA of any one of, or combination of, the following high risk HPV types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68. HPV type 18 DNA was undetectable or below the pre-set threshold.
Other HR HPV POS, HPV16 NEG, HPV18 POS
Other High Risk HPV Positive, HPV16 Negative*, HPV18 Positive. Specimen is positive for HPV type 18 DNA and the DNA of any one of, or combination of, the following high risk HPV types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68. HPV type 16 DNA was undetectable or below the pre-set threshold.
Other HR HPV POS, HPV16 NEG, HPV18 NEG
Other High Risk HPV Positive, HPV16 Negative*, HPV18 Negative*. Specimen is positive for the DNA of any one of, or combination of, the following high risk HPV types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68. HPV types 16 and 18 DNA were undetectable or below the preset threshold.
Other HR HPV NEG, HPV16 POS, HPV18 POS
Other High Risk HPV Negative*, HPV16 Positive, HPV18 Positive. HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNA were undetectable or below the pre-set threshold. Specimen is positive for HPV types 16 and 18 DNA.
Other High Risk HPV Negative*, HPV16 Negative*, HPV18 Positive. Other HR HPV NEG, HPV16 NEG, HPV18 HPV types 16, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNA POS were undetectable or below the pre-set threshold. Specimen is positive for HPV type 18 DNA. Other HR HPV NEG, HPV16 POS, HPV18 NEG
Other High Risk HPV Negative*, HPV16 Positive, HPV18 Negative*. HPV types 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNA were undetectable or below the pre-set threshold. Specimen is positive for HPV type 16 DNA.
Other HR HPV NEG, HPV16 NEG, HPV18 Other High Risk HPV Negative*, HPV16 Negative*, HPV18 Negative*. HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 NEG DNA were undetectable or below the pre-set threshold. Invalid
Invalid. The results are Invalid. Original specimen should be re-tested to obtain valid results.
Failed
No Result for Specimen Consult the cobas® 4800 system Operator’s Manual for instructions to review run flags and recommended actions. Original specimen should be re-tested to obtain valid results.
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FLAGS Result Interpretation
Table 9
Flag Code
Source
Severity
Description
R1
RI
Error
General exception raised.
R2
RI
Error
The Well Result List is null or empty.
R3
RI
Error
The Well Result Node is invalid.
R4
RI
Error
The Result Interpretation Parameters Node is null.
R5
RI
Error
The Result Interpretation Parameters Node is invalid.
R6
RI
Error
Input Xml Nodes mapping failed.
R7
RI
Error
The Result Interpretation provides 4-dyes result interpretation.
R8
RI
Error
The test ingredients have not been specified.
R9
RI
Error
The test should have at least one target and at least one internal control.
R10
RI
Error
The probes have not been specified.
R11
RI
Error
The Well Result Node attributes are invalid.
R12
RI
Error
The Algorithm Results Node is incomplete.
R13
RI
Error
The Qualitative Interpretation Tables Node is invalid.
R14
RI
Error
The Result Table Node is invalid.
R15
RI
Error
The SubTest type or the ResultTable is invalid.
R16
RI
Error
The Intermediate-Result Interpretation failed.
R17
RI
Error
The Well-Result Interpretation failed.
R18
RI
Error
The Multi-Well Result Interpretation failed.
R19
RI
Error
The Ct ranges for the intermediate interpretation are invalid.
R20
RI
Warning
The positive external control is invalid.
R21
RI
Warning
The negative external control is invalid.
Multiple or other reason Table 10 Flag Code
Source
Severity
Description
M1
SW
Error
Software error. Additional information can be found in messages and the trace log files.
M2
Other
Error
Aborted by the user
M5
SW
Warning
PCR run only with a user defined sample preparation
M6
SW
Warning
The connection to the instrument was temporarily lost
Note: One Result can have several flags.
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Host interface Manual Message types
Calculation Table 11 Flag Code
Source
Severity
Description
C1
CP
Error
General exception raised.
C2
CP
Error
The RawData node is null.
C3
CP
Error
The CalculationParameters node is null.
C4
CP
Error
The RawData node is invalid.
C5
CP
Error
The CalculationParameters node is invalid.
C6
CP
Error
Input XmlNodes mapping failed.
C7
CP
Error
The HpvCtng-CalculationPackage provides 4-dyes result interpretation.
C8
CP
Error
The test ingredients have not been specified.
C9
CP
Error
The test should have at least one target and at least one internal control.
C10
CP
Error
The probes have not been specified.
C11
CP
Error
The computation algorithm has not been specified.
C12
CP
Error
The specified algorithm is not supported by this calculation package.
C13
CP
Error
The specified algorithm version is not supported by this calculation package.
C14
CP
Error
The calculation parameters for the numeric algorithm are incomplete.
C15
CP
Error
The fluorescence measurements data is incomplete.
C101
XT
Error
The CrossTalk compensation has failed.
C102
XT
Error
The CrossTalkMatrix is null.
C103
XT
Error
The Background vector is null.
C104
XT
Error
CrossTalk Matrix has invalid entries.
C105
XT
Error
The length of the background vector is not equal with CrossTalkMatrix filter combinations count.
C106
XT
Error
Matrix coefficients calculation has failed.
C107
XT
Error
Matrix inversion has failed.
C108
XT
Error
Resolution matrix size and channel count do not match.
C121
XT
Error
The RawData node is null.
C122
XT
Error
The CalculationParameters node is null.
C123
XT
Error
The RawData node is invalid.
C124
XT
Error
The CalculationParameters node is invalid.
C125
XT
Error
General exception raised.
C221
KA2
Error
The RawData node is null.
C222
KA2
Error
The AlgorithmParameters node is null.
C223
KA2
Error
The RawData node is invalid.
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C224
KA2
Error
The AlgorithmParameters node is invalid.
C225
KA/KA2
Error
General exception raised.
C301
ELCA
Warning
CurvatureFailure
C302
ELCA
Error
InterceptOutOfRange
C303
ELCA
Error
SlopeOutOfRange
C304
ELCA
Warning
CurveFitFailure
C305
ELCA
Warning
AFIMinFailure
C306
ELCA
Error
DataRangeFailure
C307
ELCA
Info
InsufficientCurvature
C308
ELCA
Info
DeclineCorrected
C309
ELCA
Error
CTOutOfRange
C321
ELCA
Error
The RawData node is null.
C322
ELCA
Error
The CalculationParameters node is null.
A&D errors Table 12 Flag Code
Source
Severity
Z1
AnDI
Error
Description Hardware or software error from the instrument. The run was aborted.
SPI errors Table 13 Flag Code
Source
Severity
Description
X1
SPI
Error
Hardware or software error from the instrument. The run was aborted.
X2
SPI
Info
Barcode was entered manually.
X3
SPI
Error
Clot detected for a sample. This sample will have an invalid result.
X4
SPI
Error
Not enough liquid while processing a sample. This sample will have an invalid result.
X5
SPI
Error
Reagent onboard time exceeded when the user tried to start the sample preparation process. The run was aborted.
X6
SPI
Error
Working Master Mix with extract timed out after sample preparation has finished. The run was aborted.
X7
SPI
Error
Error during processing of external control. Run results will be invalid.
X8
SPI
Error
Hardware or software error from the instrument. Processing of the sample was aborted.
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5
Test Result Export workflow
Figure 2 Test Result Export After a test run the results are shown to the user and become available to be exported. Figure 2 shows this scenario.
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Host interface Manual Test Result Export workflow
6
cobas® 4800 system
ASTM Protocol
The cobas 4800 ASTM protocol also implements the ASTM E1381-91 Low Level Protocol, although this is not the focus of this manual. No changes can be made at this level and because the system is implemented over a network communication, it just acts as an intermediate level inside the application layer, transmitting the data to the upper ASTM layer. The short description of the ASTM lower layer is here for information. Message example with intermediate frame: c4800 HOST c4800
HOST c4800 HOST c4800
HOST c4800 HOST c4800 HOST c4800
00:08:17,763 [ENQ] 00:08:17,763 [ACK] 00:08:17,883 [STX]1H|\^&|||MTS^c9507f52-37bc-43d4-bba6-360fb 74bd898^OrderFileValidator^1.0.0.0918^1394.LIS2 |||||LIS|TSREQ^REAL|P|1|20091001085217|[CR][ETX ]80[CR][LF] 00:08:17,883 [ACK] 00:08:17,983 [STX]2P|1|[CR][ETX]BB[CR][LF] 00:08:17,983 [ACK] 00:08:18,103 [STX]3Q|1|^RDR0003406\RDR0003408\RDR0003407\RDR 0003405\RDR0003404\RDR0003403\RDR0003424\RDR000 3423\RDR0003422\RDR0003421\RDR0003420\RDR000341 9\RDR0003418\RDR0003417\RDR0003416\RDR0003415\R DR0003414\RDR0003413\RDR0003412\RDR0003411\RDR0 003410\RDR0[ETB]5D[CR][LF] 00:08:18,113 [ACK] 00:08:18,203 [STX]4003409\RDR0000829\RDR0003494||^^^CT/NG^^F ull|[CR][ETX]FB[CR][LF] 00:08:18,203 [ACK] 00:08:18,314 [STX]5L|1|[CR][ETX]BA[CR][LF] 00:08:18,314 [ACK] 00:08:18,414 [EOT]
Frame Configurations For Middle Frame FN text C1 C2 For Last Frame FN text C1 C2 C1C2 represent the checksum characters. Control character is control is control is control is control is control is control is control
Roche Diagnostics Host Interface manual
(characters enclosed in < > character (HEX 05) character (HEX 02) character (HEX 17) character (HEX 0D) character (HEX 0A) character (HEX 03) character (HEX 06)
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Host interface Manual ASTM Protocol
Maximum Length of the Frame For one frame, maximum of 240 characters for text, 7 characters for frame control characters (not included in the 240). Messages equal to or less than 240 characters are transmitted as one final frame. Messages greater than 240 characters are split into frames that have character lengths that fall within the 240-character limit. The only or final remaining frame becomes the last frame and is indicated by . All others are intermediate (middle) frames and are indicated by .
Results timeout: Timeout for messages sent by the cobas 4800 system: From the ENQ, the transmission including multiple frames should not exceed 120 seconds. Intermediate frames sent past this time will not be sent, the system will close the transmission with an EOT,
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COBAS 4800 ASTM Record Definitions Message Structure The Message structures are defined in the syntax also used in [2
1
]
Work order inquiry H Record
MESSAGE HEADER SEGMENT
P Record
Patient Record (empty, needed by protocol)
Q Record
Query information
L Record
ASTM message closing record
Work order response H Record
MESSAGE HEADER SEGMENT
P Record
Patient Record (empty, needed by protocol)
O Record
Order information
: :
Following O records until end of message
L Record
ASTM message closing record
Test result export H Record
MESSAGE HEADER SEGMENT
P Record
Patient Record (empty, needed by protocol)
O Record
Order information
R Record
Result information
O Record
Order information
R Record
Result information
: :
Following O / R records until end of message
L Record
ASTM message closing record
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cobas 4800 – Field mappings The tables in topic Inquiry records Mappings (ASTM) 20 are showing the mappings between the cobas 4800 xml file and the xml file which the host interface needs to work with.
Inquiry records Mappings (ASTM) H Segment Table 14 ASTM Inquiry Message Header Segment Name and Number
Type
Comment
Values
Required
H-1
String
The character H identifies the record as a message header record
H
Yes
H-2
String
Component, Repetition, Escape and Subcomponent delimiter – exactly in this order
|^ \ &
Yes
H-5-1
String
Name of the application which sent this message
MTS
Yes
H-5-2
GUID
GUID representing the unique identifier of this message given from MTS by it’s xml-filename
128-Bit-Integer Min. Value = 0 Max. Value = FFFFFFFF-FFFFFFFF-FFFFFFFFFFFFFFFF
Yes
H-5-3
String
The name or shortcut of the user which create the message
Any string
Yes
H-5-4
String
The version of the sending software
0.9.4.0847
Yes
H-5-5
Number
Protocol version – used as a version check to make sure that this message is interpreted correctly
1394.LIS2
Yes
H-10
String
Name of the application which has to receive this message
LIS
Yes
H-11-1
String
Message type used to delegate the tasks to the analyzer
TSREQ (e.g TSREQ^REAL)
Yes
H-11-2
String
Event trigger used to delegate the tasks to the analyzer
REAL (e.g TSREQ^REAL)
Yes
H-12
String
Processing mode (processing priority) P = Production
P
Yes
H-13
Number
Version number – currently a constant number set to 1
1
Yes
H-14
DateTime
DateTime of the message put by the creating system on creation of this message
YYYYMMDDhhmm Yes ss e.g. 20081122121212
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P Segment The MTS software doesn’t have any patient informations – but the ASTM protocol does need a P record. Table 15 ASTM Inquiry Patient Information Segment Name and Number
Type
Comment
Values
Required
P-1
String
The character P identifies the record as a patient record
P
Yes
P-2
Number
For the first patient transmitted, 1 shall be entered, for the second, 2, ... until the last as defined
1
Yes
Q Segment Table 16 ASTM Inquiry Request Information Segment Name and Number
Type
Comment
Values
Required
Q-1
String
This field is coded as Q.
Q
Yes
Q-2
Number
For the first patient transmitted, 1 shall be entered, for the second, 2, ... until the last as defined
1
Yes
Q-3-2
String
List of specimens separated by \ or The Plate Id for AnD Only runs (AnD workflow not supported)
020404~789043 Yes 2~098398 or AD0000034
Q-5-4
String
Test type. Example CT/NG or HPV
^^^CT/NG ^^Full
Yes
Run type - Can only be Full (Not supported SpiOnly, AnDiOnly)
^^^CT/NG^^ Full
Yes
Q-5-6
L Segment ASTM Inquiry L Segment (Message Terminator) Segment Name and Number
Type
Comment
Values
Required
L-1
String
This field is coded as L.
L
Yes
L-2
int
The Terminator field
1
Yes
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Inquiry Response Mapping H Segment This table is showing the field mappings between the MTS xml file / Transformer and the ASTM message header segment. Table 17 ASTM Response Message Header Segment Name and Number
Type
Comment
Values
Required
H-1
String
The character H identifies the record as a message header record
H
Yes
H-2
String
Component, Repetition, Escape and Subcomponent delimiter – exactly in this order
|^ \ &
Yes
H-5-1
String
Name of the application which sent this message LIS
H-5-2
GUID
GUID representing the unique identifier of this message given from MTS by it’s xml-filename
128-Bit-Integer Yes Min. Value = 0 Max. Value = FFFFFFFFFFFF-FFFF-FFFFFFFFFFFFFFFF
H-5-3
String
The name or shortcut of the user which create the message
Any string
Yes
H-5-4
String
The version of the sending software
6.2
Yes
H-5-5
Number
Protocol version – used as a version check to make sure that this message is interpreted correctly
1394.LIS2
Yes
H-10
String
Name of the application which has to receive this MTS message
Yes
H-11-1
String
Message type used to delegate the tasks to the analyzer
TSREQ (e.g TSREQ^REAL)
Yes
H-11-2
String
Event trigger used to delegate the tasks to the analyzer
REAL (e.g TSREQ^REAL)
Yes
H-12
String
Processing mode (processing priority) P = Production
P
Yes
H-13
Number
Version number – currently a constant number set to 1
1
Yes
H-14
DateTime
DateTime of the message put by the creating system on creation of this message
YYYYMMDDhhmmss e.g. 20081122121212
Yes
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Yes
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cobas® 4800 system
P Segment The cobas 4800 software does not have any patient information – but the ASTM protocol does need a P record. Table 18 ASTM Response Patient Information Segment Name and Number
Type
Comment
Values
Required
P-1
String
The character P identifies the record as a patient record
P
Yes
P-2
Number
For the first patient transmitted, 1 shall be entered, for the second, 2, ... until the last as defined
1
Yes
O Segment This table is showing the field mappings between the MTS xml file / Transformer and the ASTM test order segment. The test order segment is holding all information related to a sample. Note: Missing orders. For samples that do not have a corresponding test request in the Host system, the whole O segment record must be skipped. Table 19 ASTM Response Test Order Segment Name and Number
Type
Comment
Values
Required
O-1
String
The character assigned to the order record shall be O
O
Yes
O-2
Number
Set ID – for each order which is transmitted a own number is set starting from 1 to n
Continuous ID starting by 1 1, 2, …n
Yes
O-3-1
String
Unique identifier of the sample – usually a barcode assigned to the sample (Specimen ID)
0001301^AD0000013^A6
Yes
O-3-2
String
Plate ID – only for "AnD Only" runs
0001301^AD0000013^A6
NO
(see
Note 1) O-3-3
String
MWP Position only for "AnD Only" runs
0001301^AD0000013^A6
NO
O-5-4
String
Identifies the ‘testtype’ of the sample Known values are: - CT/NG - HPV
^^^CT/NG^NG^Full
Yes
O-5-5
String
Identifies the sub test type of a sample. Can be ^^^CT/NG^NG^Full different for each sample but must be a sub type of the TestType. Values, see Table 9
YES
O-5-6
String
Identifies the ‘runtype’ of the sample Allowed values are: - Full = Full run of all system components - AnDiOnly = AmpDetect only. See Note 1
^^^CT/NG^NG^Full
Yes
O-8
DateTime
Contents the Time when the order was created
YYYYMMDDHHMMSS e.g. 20081203143400
Yes
String ex: UT
Yes
admin
Yes
O-16
String
Media Type. Allowed values, see Table
O-17
String
Contents the user who has created the order
9
(Note see restriction 58 )
Note 1: A&D mode not supported by LIMS workflow
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L Segment ASTM response L Segment (Message Terminator) Segment Name and Number
Type
Comment
Values
Required
L-1
String
This field is coded as L.
L
Yes
L-2
int
The Terminator field
1
Yes
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Inquiry/response examples
outgoing - ASTM: H|\^&|||MTS^65745d86-7a00-49ae-98b3-8a67d18f8e31^none^0.9.8.0912^1394. LIS2|||||LIS|TSREQ^REAL|P|1|20090403081313| P|1| Q|1|^15200049\15200059\15200043\15200073\15200013\15200071\15200041 \15200011\15200069\15200039\15200009\15200067\15200037\15200007\15200065 \15200035\15200005\15200093\15200063\15200033\15200003\15200091\15200061 \15200031\15200027||^^^CT/NG^^Full| L|1| incoming - ASTM: H|\^&|||LIS^65745d86-7a00-49ae-98b3-8a67d18f8e31^none^0.9.8.0912^1394. LIS2|||||MTS|TSREQ^REAL|P|1|20090403083315| P|1 O|1|15200049^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|2|15200059^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|3|15200043^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|4|15200073^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|6|15200071^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|7|15200041^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|8|15200011^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|9|15200069^^||^^^CT/NG^CT^Full|||20090403083315||||||||UT|none O|10|15200039^^||^^^CT/NG^NG^Full|||20090403083315||||||||UT|none O|11|15200009^^||^^^CT/NG^CT/NG^Full|||20090403083315||||||||UT|none O|12|15200067^^||^^^CT/NG^CT/NG^Full|||20090403083315||||||||UUT|none O|13|15200037^^||^^^CT/NG^NG^Full|||20090403083315||||||||UUT|none O|14|15200007^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|15|15200065^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|16|15200035^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|17|15200005^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|18|15200093^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|19|15200063^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|20|15200033^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|21|15200003^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|22|15200091^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|23|15200061^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|24|15200031^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|94|15200027^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none L|1 Note: When sample numbers are received that do not have a corresponding test request in the Host system, the whole sample record must be skipped. No "empty" orders shall be sent to the cobas 4800, otherwise it will result into a complete order upload failure. Example: If the sample numbers 15200065 and 15200027 do not have a test for cobas 4800, the lines marked in bold in the ASTM response from the Host would not exist.
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Results Mapping (ASTM) H Segment This table is showing the field mappings between the MTS xml file / Transformer and the ASTM message header segment. Table 20 ASTM Response Message Header Segment Name and Number
Type
Comment
Values
Required
H-1
String
The character H identifies the record as a message header record
H
Yes
H-2
String
Component, Repetition, Escape and Subcomponent delimiter – exactly in this order
|^ \ &
Yes
H-5-1
String
Name of the application which sent this message LIS
H-5-2
GUID
GUID representing the unique identifier of this message given from MTS by it’s xml-filename
128-Bit-Integer Yes Min. Value = 0 Max. Value = FFFFFFFFFFFF-FFFF-FFFFFFFFFFFFFFFF
H-5-3
String
The name or shortcut of the user which create the message
Any string
Yes
H-5-4
String
The version of the sending software
6.2
Yes
H-5-5
Number
Protocol version – used as a version check to make sure that this message is interpreted correctly
1394.LIS2
Yes
H-10
String
Name of the application which has to receive this MTS message
Yes
H-11-1
String
Message type used to delegate the tasks to the analyzer
TSREQ (e.g TSREQ^REAL)
Yes
H-11-2
String
Event trigger used to delegate the tasks to the analyzer
REAL (e.g TSREQ^REAL)
Yes
H-12
String
Processing mode (processing priority)
P = Production
Yes
H-13
Number
Version number – currently a constant number set to 1
1
Yes
H-14
DateTime
DateTime of the message put by the creating system on creation of this message
YYYYMMDDhhmmss e.g. 20081122121212
Yes
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Yes
March 2010 Host Interface manual
Host interface Manual ASTM Protocol
cobas® 4800 system
P Segment The cobas 4800 software does not have any patient information – but the ASTM protocol does need a P record. Table 21 ASTM Response Patient Information Segment Name and Number
Type
Comment
Values
Required
P-1
String
The character P identifies the record as a patient record
P
Yes
P-2
Number
For the first patient transmitted, 1 shall be entered, for the second, 2, ... until the last as defined
1
Yes
O Segment This table is showing the field mappings between the MTS xml file / Transformer and the ASTM test order segment. The test order segment is holding all information related to a sample. Table 22 ASTM Test Order Segment Name and Number
Type
Comment
Values
Required
O-1
String
The character assigned to the order record shall be O
O
Yes
O-2
Number
Set ID – for each order which is transmitted a own number is set starting from 1 to n
Continuous ID starting by 1 1, 2, …n
Yes
O-3-1
String
Unique identifier of the sample – usually a barcode assigned to the sample (Specimen ID)
0001301^AD0000013^A6 Yes
O-3-2
String
Plate ID – only for AnD Only runs
0001301^AD0000013^A6 NO
O-3-3
String
MWP Position only for AnD Only runs
0001301^AD0000013^A6 NO
O-4
String
Run type of the test
Full or AnD Only
Yes
O-5-4
String
Identifies the ‘testtype’ of the sample allowed values are: - CTNG - HPV
^^^CT/NG^NG^Full
Yes
O-5-5
String
Identifies the sub test type of a sample. Can be ^^^CT/NG^NG^Full diffrent for each sampl but must be a sub type of the TestType. See Table 9
YES
O-5-6
String
Identifies the ‘runtype’ of the sample Allowed values are: - Full = Full run of all system components - AnDiOnly = AmpDetect only
^^^CT/NG^NG^Full
Yes
O-8
DateTime
Contents the Time when the order was created
YYYYMMDDHHMMSS e.g. 20081203143400
Yes
O-16
String
Media Type Allowed values see Table
String ex: UT
Yes
9
O-17
String
Contents the user who has created the order
admin
Yes
O-26
String
Type of Results: F=Final Results; P=preliminary results – depends of the result export flag “Áccepted”. F Means result was accepted P Means result was not accepted (yet)
F or P
Yes
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.
R Segment Note: The system presents CT/NG or HPV as global blocks of results and transmits them as such. The Host system may have to further parse the result block if a further separation of individual subcomponents is required . See the tables 11 for details and possible combinations inside result blocks. Table 23 ASTM Result Record Segment Type Name and Number
Comment
Values
Require d
R-1
String
The record type ID is coded as R.
R
Yes
R-2
Number
Set ID – for each order which is transmitted a own number is set starting from 1 to n
Continuous ID starting by 1 1, 2, …n
Yes
R-3-4
String
Identifies the ‘testtype’ of the sample Known values are: - CT/NG - HPV
^^^CT/NG^NG^Full
Yes
R-3-5
String
Identifies the sub test type of a sample. Can be diffrent ^^^CT/NG^NG^Full for each sampl but must be a sub type of the TestType Ex: CT see table 9
YES
R-3-6
String
Identifies the ‘runtype’ of the sample Allowed values are: - Full = Full run of all system components - AnDiOnly = AmpDetect only
^^^CT/NG^NG^Full
Yes
R-4-1
String
Application package defined test result e.g. Positive, see table 10 .
Positive^M1\M2
Yes
R-4-2
String
Flags for the test result See example
Positive^M1\M2
Yes
R-4-3
String
CT-Values of the controls
CT_DYE1^NaN^ CT_DYE5^NaN^ CT_DYE3^NaN^ CT_DYE0^NaN
NO
R-11
String
User who has run the test
laboperator
Yes
R-12
DateTime Time when the test was started on the instrument
YYYYMMDDHHMMS S e.g. 20081203143400
Yes
R-13
DateTime Time when the test was finished on the instrument
YYYYMMDDHHMMS S e.g. 20081203143400
Yes
30
L Segment Segment Name and Number
Type
Comment
Values
Required
L-1
String
This field is coded as L.
L
Yes
L-2
int
The Terminator field
1
Yes
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Results Example ASTM (Simulator log) outgoing - ASTM: c4800 HOST c4800
HOST c4800 HOST c4800
HOST c4800
HOST c4800
HOST c4800
HOST c4800
HOST c4800
HOST c4800
HOST c4800
HOST c4800
HOST c4800
HOST c4800
HOST c4800
00:11:52,652 [ENQ] 00:11:52,652 [ACK] 00:11:52,762 [STX]1H|\^&|||MTS^e5052475-cdb3-4c13-97d4-2bb43 467e75f^^1.0.0.0918^1394.LIS2|||||LIS|TSREQ^REA L|P|1|20091001085550|[CR][ETX]FA[CR][LF] 00:11:52,782 [ACK] 00:11:52,872 [STX]2P|1|[CR][ETX]BB[CR][LF] 00:11:52,872 [ACK] 00:11:52,982 [STX]3O|1|0NCL010145A03DC^AD6002095^B1||CT/NG^F ull|||20090825020548|||||||20090825143017|NegCt rl||||||||||F|[CR][ETX]B0[CR][LF] 00:11:52,992 [ACK] 00:11:53,092 [STX]4R|1|^^^CT/NG^N/A^Full|Valid^^CT_DYE0\NaN\ CT_DYE5\34.949874877929688\CT_DYE1\NaN|||||||La bmanager|20090825140628|20090825170656|[CR][ETX ]7F[CR][LF] 00:11:53,102 [ACK] 00:11:53,203 [STX]5O|2|1C1M014196A012R^AD6002095^A1||CT/NG^F ull|||20090825020548|||||||20090825143017|PosCt rl||||||||||F|[CR][ETX]B4[CR][LF] 00:11:53,213 [ACK] 00:11:53,313 [STX]6R|1|^^^CT/NG^N/A^Full|Valid^^CT_DYE0\36.5 50521850585938\CT_DYE5\35.303115844726562\CT_DY E1\35.388565063476562|||||||Labmanager|20090825 140628|20090825170656|[CR][ETX]B4[CR][LF] 00:11:53,323 [ACK] 00:11:53,423 [STX]7O|3|RDR0003428^AD6002095^H1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]98[CR][LF] 00:11:53,433 [ACK] 00:11:53,533 [STX]0R|1|^^^CT/NG^CT/NG^Full|CT·POS,·NG·POS^|| |||||Labmanager|20090825140628|20090825170656|[ CR][ETX]B4[CR][LF] 00:11:53,543 [ACK] 00:11:53,643 [STX]1O|4|RDR0003430^AD6002095^G1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]8B[CR][LF] 00:11:53,653 [ACK] 00:11:53,753 [STX]2R|1|^^^CT/NG^CT/NG^Full|CT·POS,·NG·POS^|| |||||Labmanager|20090825140628|20090825170656|[ CR][ETX]B6[CR][LF] 00:11:53,753 [ACK] 00:11:53,854 [STX]3O|5|RDR0003432^AD6002095^F1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]8F[CR][LF] 00:11:53,864 [ACK] 00:11:53,964 [STX]4R|1|^^^CT/NG^CT/NG^Full|CT··NEG,·NG·POS^| ||||||Labmanager|20090825140628|20090825170656| [CR][ETX]C0[CR][LF] 00:11:53,974 [ACK] 00:11:54,074 [STX]5O|6|RDR0003433^AD6002095^E1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]92[CR][LF] 00:11:54,084 [ACK] 00:11:54,184 [STX]6R|1|^^^CT/NG^CT/NG^Full|CT·POS,·NG··NEG^|
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HOST c4800
00:11:54,194 00:11:54,294
HOST c4800
00:11:54,304 00:11:54,404
HOST c4800
00:11:54,414 00:11:54,515
HOST c4800
00:11:54,525 00:11:54,625
HOST c4800 HOST c4800
00:11:54,635 00:11:54,725 00:11:54,735 00:11:54,835
||||||Labmanager|20090825140628|20090825170656| [CR][ETX]C2[CR][LF] [ACK] [STX]7O|7|RDR0003435^AD6002095^C1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]95[CR][LF] [ACK] [STX]0R|1|^^^CT/NG^CT/NG^Full|CT··NEG,·NG··NEG^ X2|||||||Labmanager|20090825140628|200908251706 56|[CR][ETX]4E[CR][LF] [ACK] [STX]1O|8|RDR0003436^AD6002095^D1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]92[CR][LF] [ACK] [STX]2R|1|^^^CT/NG^CT/NG^Full|CT··NEG,·NG··NEG^ |||||||Labmanager|20090825140628|20090825170656 |[CR][ETX]C6[CR][LF] [ACK] [STX]3L|1|[CR][ETX]B8[CR][LF] [ACK] [EOT]
Note: The bullet character inside results is just a placeholder to visualize the spaces inside strings. example |CT·POS,·NG··NEG^| should look in reality: |CT POS, NG NEG^| The character used in the transmission is a regular space (Hex 20).
Example multiple flags (R segment only, simulator log) outgoing - ASTM: c4800
06:53:16,137 [STX]6R|1|^^^HPV^HPV·High·Risk·Panel·+·Genotypi ng^Full|Failed^X3\X4\X1|||||||GT|20091211133042 |20091211153236|[CR][ETX]69[CR][LF]
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7
cobas® 4800 system
HL7 Protocol
Minimal Layer Protocol The data framing uses the MLLP, Minimal Lower Layer Protocol defined in the HL7 standard. HL7 messages are embedded in block delimited by special (non printable) characters. data The values of the special characters are for the start block and for the end block. See table below.
Start Block character (1 byte) ASCII
Data
(variable number of bytes) The HL7 data is comprised of any displayable ASCII characters and the carriage return character, .
.
End Block character (1 byte) ASCII . Carriage Return (1 byte)
Char (ASCII)
Décimal
Octal
Hex
Name
VT
011
013
0B
Vertical Tab
FS
028
034
1C
File Separator
CR
013
015
0D
Carriage Return
Graphical representation of data framing:
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COBAS 4800 HL7 Record Definitions The tables in the topic Inquiry Records mapping (HL7) 33 show the mappings between the cobas 4800 xml file and the HL7 segment / records file which the host interface needs to work with.
Message Structure The Message structures are defined in the syntax also used in [1]
1
Work order inquiry MSH
MESSAGE HEADER SEGMENT
QPD
QUERY PARAMETER DEFINITION
RCP
RESPONSE CONTROL PARAMETER SEGMENT
Work order response MSH
MESSAGE HEADER SEGMENT
{ ORC
COMMON ORDER SEGMENT - Multiple times ORC + OBR
{ OBR
OBSERVATION REQUEST SEGMENT
} }
Test result export MSH
MESSAGE HEADER SEGMENT
{ ORC
COMMON ORDER SEGMENT - Multiple times ORC + OBR + OBX
{ OBR
OBSERVATION REQUEST SEGMENT
OBX
OBSERVATION/RESULT SEGMENT
} }
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Inquiry Records mapping (HL7) Inquiry Mapping
MSH Segment (Message Header) Table 24 HL7 Inquiry Message Header Segment Name and Number
Type
Comment
Values
Required
MSH-1
String
Field delimiter
|
Yes
MSH-2
String
Component, Repetition, Escape and Subcomponent delimiter – exactly in this order
^~\&
Yes
MSH-3
String
Name of the application which sent this message
MTS
Yes
MSH-4
String
The version of the sending software
e.g. 1.3.5
Yes
MSH-5
String
Name of the application which has to receive this message
LIS
Yes
MSH-7
DateTime
DateTime of the message
YYYYMMDDhh mmss e.g. 20081122121212
Yes
MSH-9-1
String
Message type code – see HL7 Doc.: [1] Table 0076 - Message type
QBP (QBP^Q11) Yes
MSH-9-2
String
Trigger event code – see HL 7 Doc.: [1] Table 0003 - Event type
Q21 (QBP^Q11)
Yes
MSH-10
GUID
Message Id – Generated by the Transformer Software
128-Bit-Integer Min. Value = 0 Max. Value = FFFFFFFF-FFFFFFFF-FFFFFFFFFFFFFFFF
Yes
MSH-11
String
Processing mode (processing priority) see HL7 Doc.: [1] Table 0103 - Processing ID
P = Production
Yes
MSH-12
Number
HL7 Version ID – used as a version check to make sure that this message is interpreted correctly see HL7 Doc.: [1] Table 0104 – Version ID
2.4
Yes
MSH-17
String
Country ISO code used for currency-, datetime- and other specifications. [1] Table 0399 – Country code
[A-Z]{3} Yes e.g. CHE = Switzerland, USA = United States
MSH-18
String
Character char set used for the whole message - see HL7 Doc.: [1] Table 0211 – Alternate character sets The COBAS 4800 project has decided to use the not documented character set UTF-8
UTF-8
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QPD - Query Parameter Definition Table 25 HL7 Inquiry Query Parameter Definition Segment Name and Number
Type
Comment
Values
Required
QPD-1
String
This field contains the name of the query
FullRunQuery or AnDOnlyQuery
YES
QPD-3
String
Test Specification contains the Test Type and the Run Type (only "Full" supported)
CT/NG^FULL
YES
QPD-4
String
All Samples or the Plate ID of the MWP Plate
AD0000012 or 0001~0002~000 3~0004
YES
RCP - Response Control Parameter Segment Table 9 HL7 Inquiry Response Control Parameter Segment Segment Name and Number
Type
Comment
Values
Required
RCP-1
String
Query priority – For cobas 4800 always I=Immediate
I
YES
RCP-3
String
Response modality – For cobas 4800 always R=Real Time
R
YES
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Inquiry Response Mapping
MSH Segment (Message Header) Table 26 HL7 Response Message Header Segment Name and Number
Type
Comment
Values
Required
MSH-1
String
Field delimiter
|
Yes
MSH-2
String
Component, Repetition, Escape and Subcomponent delimiter – exactly in this order
^~\&
Yes
MSH-3-1
String
Name of the application which sent this message
LIS
Yes
MSH-4-1
String
The version of the sending software
6.2
Yes
MSH-5-1
String
Name of the application which has to receive this message MTS
Yes
MSH-7
DateTime
DateTime of the message
YYYYMMDDhhm mss e.g. 20081122121212
Yes
MSH-9-1
String
Message type code – see HL7 Doc.: [1] Table 0076 - Message type
OML (OML^O21)
Yes
MSH-9-2
String
Trigger event code – see HL 7 Doc.: [1] Table 0003 - Event type
O21 (OML^O21)
Yes
MSH-10
GUID
Message Id – Generated by the Transformer Software
128-Bit-Integer Min. Value = 0 Max. Value = FFFFFFFF-FFFFFFFF-FFFFFFFFFFFFFFFF
Yes
MSH-11
String
Processing mode (processing priority) see HL7 Doc.: [1] Table 0103 - Processing ID
P = Production
Yes
MSH-12
Number
Version ID – used as a version check to make sure that this message is interpreted correctly see HL7 Doc.: [1] Table 0104 – Version ID
2.4
Yes
MSH-17
String
Country ISO code used for currency-, datetime- and other specifications. The value is mapped from the current thread of the Transformer application [1] Table 0399 – Country code
[A-Z]{3} Yes e.g. CHE = Switzerland, USA = United States
MSH-18
String
Character char set used for the whole message - see HL7 Doc.: [1] Table 0211 – Alternate character sets The cobas 4800 project has decided to use the not documented character set UTF-8
UTF-8
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ORC Segment (Common Order) Table 11 HL7 Response Common Order Segment Name and Number
Type
Comment
Values
Required
ORC-1
Number
Set ID – for each order which is transmitted a own number is set starting from 1 to n
Continuous ID starting by 1 1, 2, …n
Yes
ORC-7-4
DateTime
This field contains the creation time of the order out of the cobas 4800 order file
20081202154500
YES
ORC-10
String
This field contains the identity of the user who actually created the order out of the cobas 4800 order file.
e.g ADMIN
YES
OBR – Segment (Observation Request) This table is showing the field mappings between the cobas 4800 xml file / Transformer and the HL7 message version 2.4 observation request segment. The observation request segment is holding all information related to a sample. Table 12 HL7 Response Observation Request Segment Name
Type
Comment
OBR-1
Number
Set ID – for each order which is transmitted a Continuous ID starting by Yes own number is set starting from 1 to n 1 1, 2, …n
OBR-3-1
String
Unique identifier of the sample – usually a barcode assigned to the sample
0001301 ^AD0000013^A6
YES
OBR-3-2
String
Plate ID – only for A&D Only runs. See Note 1
0001301^AD0000013 ^A6
NO
OBR-3-3
String
MWP Position only for A&D Only runs
0001301^AD0000013^ A6
NO
OBR-4-1
String
Identifies the ‘testtype’ of the sample Known values are: CTNG - HPV
CT/NG^NG^Full
Yes
OBR-4-2
String
The sub test type of a sample. Values, see Table 9
CT/NG^NG^Full
YES
OBR-4-3
String
Identifies the ‘runtype’ of the sample Allowed values are: See Note 1 - Full = Full run of all system components - SpiOnly = Sample Extraction only - AnDiOnly = AmpDetect only
CT/NG^NG^Full
Yes
OBR-15
String
Media Type Allowed values : see Table
String ex: UT
Yes
YYYYMMDDhhmmss e.g. 20081122121212
Yes
OBR-27
XML DateTime
Values
Require d
9
Xml DateTime of the message put by the creating system on creation of this message
Note 1 : Only "Full" is supported by the HIF workflow.
Note 2 : Missing orders For samples that do not have a corresponding test request in the Host system, the whole ORC + OBR segment records pair must be skipped.
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Results Mapping (HL7) MSH Segment (Message Header) Table 13 HL7 Result Message Header Segment Name and Number
Type
Comment
Values
Requir ed
MSH-1
String
Field delimiter
|
Yes
MSH-2
String
Component, Repetition, Escape and Subcomponent delimiter ^ ~ \ & – exactly in this order
Yes
MSH-3-1
String
Name of the application which sent this message
MTS
Yes
MSH-4-1
String
The version of the sending software
0.9.4.847
Yes
MSH-5-1
String
Name of the application which has to receive this message
LIS
Yes
MSH-7
DateTime
DateTime of the message
YYYYMMDDhh mmss e.g. 20081122121212
Yes
MSH-9-1
String
Message type code – see HL7 Doc.: [1] Table 0076 - Message type
ORU (ORU^O21)
Yes
MSH-9-2
String
Trigger event code – see HL 7 Doc.: [1] Table 0003 - Event type
O21 (ORU^O21) Yes
MSH-10
GUID
Message Id – Generated by the Transformer Software
TBD
Yes
MSH-11
String
Processing mode (processing priority) see HL7 Doc.: [1] Table 0103 - Processing ID
P = Production
Yes
MSH-12
Number
Version ID – used as a version check to make sure that this message is interpreted correctly see HL7 Doc.: [1] Table 0104 – Version ID
2.4
Yes
MSH-17
String
Country ISO code used for currency-, datetime- and other specifications. [1] Table 0399 – Country code
[A-Z]{3} e.g. CHE = Switzerland, USA = United States
Yes
MSH-18
String
Character char set used for the whole message - see HL7 Doc.: UTF-8 [1] Table 0211 – Alternate character sets The cobas 4800 project has decided to use the not documented character set UTF-8
Yes
ORC – Segment (Common Order) Table 14 HL7 Result Common Order Segment Name and Number
Type
Comment
Values
Requir ed
ORC-1
Number
Set ID – for each order which is transmitted a own number is set starting from 1 to n
Continuous ID starting by 1 1, 2, …n
Yes
ORC-7-4
DateTime
This field contains the creation time of the order out of the cobas 4800 order file
20081202154500
YES
ORC-10
String
This field contains the identity of the user who actually created e.g ADMIN the order out of the cobas 4800 order file.
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OBR - Segment (Observation Request) This table is showing the field mappings between the cobas 4800 xml file / Transformer and the HL7 message observation request segment. The observation request segment is holding all information related to a sample. Table 15 HL7 Result Observation Request Segment Name and Number
Type
Comment
Values
Require d
OBR-1
Number
Set ID – for each order which is transmitted a own number is set starting from 1 to n
Continuous ID starting by 1 1, 2, …n
Yes
OBR-3-1
String
Unique identifier of the sample – usually a barcode assigned to the sample
0001301^AD000001 3^A6
YES
OBR-3-2
String
Plate ID – only for AnD Only runs
0001301^AD000001 3^A6
NO
OBR-3-3
String
MWP Position only for AnD Only runs
0001301^AD000001 3^A6
NO
OBR-4-1
String
Identifies the ‘testtype’ of the sample Known values are: CT/NG - HPV
CT/NG^NG^FULL
YES
OBR-4-2
String
The sub test type of a sample See possible value table 9 :
CT/NG^NG^FULL
YES
OBR-4-3
String
The run type of the test
CT/NG^NG^FULL
YES
OBR-7
DateTime
Time the test was started on the instrument
YYYYMMDDhhmms YES s e.g. 20081122121212
OBR-8
DateTime
Time the test was finished on the instrument
YYYYMMDDhhmms YES s e.g. 20081122121212
OBR-15
String
Allowed values are: See table 9
UUT
OBR-27
DateTime
Time when the order was created
YYYYMMDDhhmms YES s e.g. 20081122121212
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OBX - Segment (Observation / Result Segment) Note: The system presents CT/NG or HPV as global blocks of results and transmits them as such. The Host system may have to further parse the result block if a further separation of individual subcomponents is required . See the tables 11 for details and possible combinations inside result blocks. Table 16 HL7 Result Observation / Result Segment Segment Name and Number
Type
Comment
Values
Require d
OBX-1
String
Set ID – for each order which is transmitted a own number is set starting from 1 to n
Continuous ID starting by 1 1, 2, …n
Yes
OBX-2
String
This field contains the format of the observation value in OBX – For the cobas 4800 the format is ST = String Data
ST
YES
OBX-3-1
String
Unique identifier of the sample – usually a barcode assigned to the sample
0001301^AD000001 YES 3^A6
OBX-3-2
String
Plate ID – only for AnD Only runs
0001301^AD000001 NO 3^A6
OBX-3-3
String
MWP Position only for AnD Only runs
0001301^AD000001 NO 3^A6
OBX-5-1
String
Application package defined test result e.g. Postive, Failed, … See table 10
Positive^M1~M2
YES
OBX-5-2
String
Flags for the test result
Positive^M1~M2
YES
OBX-5-3
String
CT-Values of the controls
CT_DYE1^NaN^ CT_DYE5^NaN^ CT_DYE3^NaN^ CT_DYE0^NaN
NO
OBX-11
String
Accepted Flag possible values are: Final results = ‘F’ or ‘Final results = ‘P’ it depends on the accepted flags from the cobas 4800 result export file F Means result was accepted P Means result was not accepted (yet)
F or P
YES
OBX-16
String
User of the instrument who run the test
laboperator
YES
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Result Example HL7
HL7 Result Export (Simulator log) c4800 c4800
c4800 c4800
c4800
c4800 c4800
c4800
c4800 c4800
c4800
c4800 c4800
c4800
c4800 c4800
c4800
c4800 c4800
c4800
c4800 c4800
10:14:27,257 [VT] 10:14:27,257 MSH|^~\&|MTS|1.0.0.0918|LIS||20090918101319||OR U^O21|9a7b5dab-8049-4ba8-83b7-6e8aefcbbed1|P|2. 5.1|||||CHE|UTF-8|[CR] 10:14:27,257 ORC|1||||||^^^20090826114803||||[CR] 10:14:27,257 OBR|1||0NCL010145A037Y^AD6002084^B1|HPV^N/A^Ful l|||20090826120921|20090826154328|||||||NegCtrl ||||||||||||20090826114803|[CR] 10:14:27,257 OBX|1|ST|0NCL010145A037Y^AD6002084^B1||Valid^^C T_DYE3~NaN~CT_DYE5~NaN~CT_DYE1~NaN~CT_DYE0~NaN| |||||P|||||Labmanager|[CR] 10:14:27,273 ORC|2||||||^^^20090826114803||||[CR] 10:14:27,273 OBR|2||R0000814^AD6002084^G1|HPV^HPV·High·Risk· Panel·+·Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ] 10:14:27,273 OBX|2|ST|R0000814^AD6002084^G1||Other·HR·HPV·NE G,·HPV16·POS,·HPV18·NEG^||||||P|||||Labmanager| [CR] 10:14:27,288 ORC|3||||||^^^20090826114803||||[CR] 10:14:27,288 OBR|3||R0000815^AD6002084^F1|HPV^HPV·High·Risk· Panel·+·Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ] 10:14:27,288 OBX|3|ST|R0000815^AD6002084^F1||Other·HR·HPV·NE G,·HPV16·NEG,·HPV18·POS^||||||P|||||Labmanager| [CR] 10:14:27,288 ORC|4||||||^^^20090826114803||||[CR] 10:14:27,304 OBR|4||R0000816^AD6002084^D1|HPV^HPV·High·Risk· Panel·+·Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ] 10:14:27,304 OBX|4|ST|R0000816^AD6002084^D1||Other·HR·HPV·PO S,·HPV16·NEG,·HPV18·NEG^||||||P|||||Labmanager| [CR] 10:14:27,304 ORC|5||||||^^^20090826114803||||[CR] 10:14:27,304 OBR|5||R0000817^AD6002084^E1|HPV^HPV·High·Risk· Panel·+·Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ] 10:14:27,320 OBX|5|ST|R0000817^AD6002084^E1||Other·HR·HPV·PO S,·HPV16·POS,·HPV18·NEG^||||||P|||||Labmanager| [CR] 10:14:27,320 ORC|6||||||^^^20090826114803||||[CR] 10:14:27,320 OBR|6||R0000819^AD6002084^C1|HPV^HPV·High·Risk· Panel·+·Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ] 10:14:27,335 OBX|6|ST|R0000819^AD6002084^C1||Other·HR·HPV·PO S,·HPV16·POS,·HPV18·POS^||||||P|||||Labmanager| [CR] 10:14:27,335 ORC|7||||||^^^20090826114803||||[CR] 10:14:27,335 OBR|7||R0000818^AD6002084^H1|HPV^HPV·High·Risk· Panel·+·Genotyping^Full|||20090826120921|200908
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c4800
10:14:27,335
c4800 c4800
10:14:27,351 10:14:27,351
c4800
10:14:27,351
cobas® 4800 system
26154328|||||||PC||||||||||||20090826114803|[CR ] OBX|7|ST|R0000818^AD6002084^H1||Other·HR·HPV·In valid,·HPV16·Invalid,·HPV18·POS^||||||P|||||Lab manager|[CR] ORC|8||||||^^^20090826114803||||[CR] OBR|8||2H1M015776A02IG^AD6002084^A1|HPV^N/A^Ful l|||20090826120921|20090826154328|||||||PosCtrl ||||||||||||20090826114803|[CR] OBX|8|ST|2H1M015776A02IG^AD6002084^A1||Valid^^C T_DYE3~37.381362915039062~CT_DYE5~35.7265472412 10938~CT_DYE1~36.203384399414062~CT_DYE0~35.940 170288085938||||||
Note: The bullet character inside results is just a placeholder to visualize the spaces inside strings. example Other·HR·HPV·POS should look in reality: Other HR HPV POS The character used in the transmission is a regular space (Hex 20).
Example multiple flags (OBX segment only, simulator log) outgoing - HL7: c4800
08:05:32,833 OBX|79|ST|A2482185^AD6201793^D3||Failed^X3~X4~X1|| ||||F|||||GT|[CR]
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8
Communication setup
Network connection The physical connection used by the cobas 4800 host interface is the standard network card (N.I.C) with Ethernet protocol. The network address of the instrument is normally determined by the installation of a cobas IT firewall. To change the network address, you must log into the operating system as local Administrator. Please ask the Roche service representative.
Instrument Setup By default the HIF modules are not installed, for the instrument setup, please refer to the Network Configuration Guide cobas 4800 system. This installation has to be performed by qualified Roche service personnel. Once the software for host interface has been installed, some parameters can be changed to match the requirements of the LIS system. The default protocol after installation is HL7. To change to ASTM, or back to HL7, change the target IP (LIS system) or the port, see the the Network Configuration Guide cobas 4800 system.
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9
cobas® 4800 system
Simulator
Installing simulators Roche has developed specific host simulators to make simple testing of the ASTM or HL7 protocol, for the cobas 4800 Instrument. This software can be installed on Windows computers and are intended to be used only by Roche trained personnel. When used as an instrument simulator, the goal is to provide only a quick test tool for testing the transmission formats. Please keep in mind that the simulator does not react like a real instruments in all situations. The simulator is intended to be used for several Roche instruments, periodically new ones will be added. From version 2.0 on, all the host interface tools come together in a common installation package. They will be installed by default under Host Interface tools.
Requirements The Roche ASTM/HL7 simulators can be installed on Windows XP computers. The user needs administrator rights to be able to install the host tools package properly. After the basic installation of the "Host tools" package, some patches may be required depending on the simulator you intend to use. Please ask the Roche service representative for further information. Software requirement: Windows XP professional SP2, with current patches. Access to network settings Recommended hardware: Any computer able to run Windows XP professional. Network card
HL7 Simulator Roche has developed a specific host simulator to make simple testing of the HL7 protocol, for the cobas 4800 Instrument. To start the simulator, simply select from the stat menu as shown.
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You must accept the disclaimer to be able to start the program.
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Setting up the simulator connection Some parameters must be setup before the cobas 4800 system is able to communicate with the simulator.
The simulator must be set up as a server. That is, it will listen on a defined port. Port 5555 is often used as a default. The server IP address is the address of the network card and cannot be changed for a server. It comes from the network settings of the computer hosting the simulator. This is the same as the LIS address that must be set on the cobas 4800 when installing or setting up the Host. See Instrument setup 42
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Select the Instrument "cobas 4800" from the drop down list and "Host" as shown. This has the effect of enabling the correct responses from the simulator to the selected type of instrument. Note: The simulator can also simulate a cobas 4800 system, but this mode goes beyond the scope of this manual
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Once parameters are setup correctly the simulator will start listening on the defined port. Once every minute, the cobas 4800 communication server will attempt a connection on the defined IP address and port. If the simulator is reached, the connection indicator will turn from yellow to green as shown. Additionally, the IP address of the connected system will appear in the lower part of the blue box (Remote). At this point the simulator can be used and will display the HL7 records received and sent.
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Connection test When the simulator is connected, the connection test gives a possibility to check the responsiveness of the client. In some circumstances, the simulator may erroneously indicate an active connection. This can be the case if there are elements in the network that where temporarily disconnected.
If the LIS seems unresponsive although the connection is displayed as active, make the connection check.
In case of test failure, close the simulator and restart it. If the connection is not re-established within two minutes, shutdown the cobas 4800 system and restart it.
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Sending an order to the system Actually, you cannot "send" an order, as the instrument is always master. The simulator is able to reply to an order request. For this it must have certain information in its database. You can edit this database manually to prepare a correct answer to instrument queries. Simulator Database: The simulator has a small database where basic records can be stored. The simulator will use its database records to respond to the instrument requests. If the instrument sends a request related to a certain Sample ID, the simulator will search its database for a matching record. If one is found, the simulator will attempt to generate an order upload, using the information stored in the simulator database record. To open the database on the simulator:
Then in the DB, select the table as shown.
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You can generate new records, either blank ones:
Or duplicate existing ones and editing them:
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Editing the duplicate record:
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There are further fields on the right that can be edited: (Use lower slide bar to view them).
Note: Be aware that the simulator does not perform any check on the type of data. Verify with the protocol definitions that you enter valid data. For example, if you type a number where another type is required, an error will probably be generated at the instrument level and the order rejected. (see also restrictions 58 )
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Receiving results from the system. Once the LIS systems have been installed by a Roche engineer, the system must be configured to work with LIS: To configure cobas 4800 software for LIS communication, the user must first open cobas 4800 software and log in with username FSE. Only a user with administrator rights to the application can switch the LIS on. Go to 1)utilities tab, select 2) configuration tab, select 3) System Settings and 4) enable the checkbox LIS present.
Exit cobas 4800 software. TO be able to transmit results, once the LIS has been activated, it is necessary to log in as 1. Open the cobas 4800 Software 2. Login with user name FSE Go to 1) result tab, select 2) performed run, select 3) sample, click 4) Export All results present in the page will be transmitted, even if only one is selected.
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Results received by the simulator will be stored in the database as shown below.
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cobas® 4800 system
Host interface Manual Simulator
Roche Diagnostics Page 56
DRAFT
March 2010 Host Interface manual
Host interface Manual Simulator
cobas® 4800 system
ASTM Simulator Roche has developed a specific host simulator to make simple testing of the ASTM protocol, for the cobas 4800 Instrument. This software can be used on Windows XP computers and can be delivered upon request. Contact your Roche Diagnostics representative. The simulator is intended to be used for several Roche instruments, periodically new ones will be added.
Requirements The Roche ASTM simulator can be installed on Windows XP computers and is part of the complete host tools package. refer to the previous topic HL7 simulator, the ASTM simulator works in a very similar way and shares the loacl simulator database with the HL7 simulator. The user needs administrator rights to be able to install the host tools package properly. Software requirement: Windows XP professional SP2, with current patches. Access to network settings Recommended hardware: Any computer able to run Windows XP professional. Network card
Setting up and operating the ASTM simulator To setup and operate the ASTM simulator as a host, read the HL7 simulator sections 43 . The ASTM simulator operates in a very similar way and shares the simulator datatabase for cobas 4800.
Roche Diagnostics Host Interface manual
DRAFT
March 2010 Page 57
cobas® 4800 system
Host interface Manual Simulator
10
Troubleshooting / logfiles
Troubleshoting: Most errors in the incoming communications i.e. a missing parameter in a filed, will result in a timeout message on the instrument. Errors generated by the conversion from incoming HTML or ASTM are not passed to the application, the Transformer program will only pass XML files if the parsing or the different fields succeeds. If any error occur it will just stop parsing the information and do nothing, therefore if the application is awaiting an answer, it will just timeout. To find the source of the problem, see the logfiles section. If the cobas 4800 system has an active connection to the host system but fails to request order information after loading sample racks, one possible cause is the "operator" is not logged into the operating system of the cobas 4800 control unit. If an administrator is logged into the windows operating system, the LIS service will connect to the ASTM or HL7 server but the system will not be able to communicate. Corrective action: log off the administrator user in Windows, the system will automatically re-log as "operator"
Logfiles: In the directory c:\data\log, the trafic for the selected protocol is logged: Hl7_trace.log for the Hl7 data exchange. astm_trace.log for the astm data exchange. The transformation activity of the transformer program .xml active protocol is logged in the file cserver.log cserver logfiles are collections of incremental files like cserver.log.1, cserver.log.2 ....... As soon as the cserver.log reaches a size of 1025 kB, a number is appended to the extension and a new cserver.log is created. In the directory C:programm files\Roche diagnosticsAG\cobas_4800_v1.0.0.0918\bin\log\ the file MTS-Transformer-session-trace-file.log contains the parsing activity for the active protocol. To find the captured errors, open the file with the windows notepad program and make a search fro "ERROR". You may find some limited indications about protocol errors. (e.g an incorrect type or missing mandatory parameter).
11
Known restrictions
Workflow: Only the Full run is supported by LIS. The "A&D" and "Sample extraction only" modes are not supported by the LIS system. The timeout after an order request from the instrument is currently set at 30 seconds and cannot be changed. Because of this relatively short time out, it is recommended to use only direct network connections between the LIS and the cobas 4800 system. Avoid any bottlenecks, i.e. converters to RS232 serial line. Order processing on the LIS should be optimized to avois a timeout when loading the maximum samples.
Troubleshooting errors: In case of protocol errors (i.e. the LIS sending an incorrect data type or unexpected values), the instrument will report “LIS system does not answer (timeout)” in most cases. This can be misleading, however some information might be available in the logfiles. See Troubleshooting 58
ASTM: Roche Diagnostics Page 58
DRAFT
March 2010 Host Interface manual
Host interface Manual Known restrictions
cobas® 4800 system
O segment in order response: Field O-8 if left blank will not create a failure, although this is documented as “required” field. HL7: No Known problem
Roche Diagnostics Host Interface manual
DRAFT
March 2010 Page 59
Keywords index -AA&D
3, 8, 13
A&D Only
6
active connection AnD
49
3
ASCII
31
ASTM simulator
57
-CCalculation checksum
13 17
Client /Server structure cobas x 480
3
cobas z 480
3
Control character
4
17
-Ddata framing
31
-Eempty orders error
6
13, 50
errors
58
-FFLAGS
13
Frame final frame
17
intermediate frame Length of the Frame Middle Frame
Full
17 17
17
6
Full run
3, 8
-GGUID
3, 20, 22, 26, 33, 35
-Hhost simulator
43
-Iinquiry timeout
6
installation Manual
-Llayer Logfiles
5 58
42
-MMedia Type
8
Message Terminator Micro Well Plate
24
3
Minimal Layer Minimal Layer Protocol
Missing orders MLLP
31
6, 23, 35
31
MTS
3
MWP
3
MWP plate
6
-NNetwork Configuration Guide
-Oorder request
50
OSI model
5
-Ppatient information
23, 27
physical connection
4
-Rrequirement
43
Requirements reserveCyt
43
8
Results timeout run
17
8
Run Type
6, 8
-Sserver
6, 46
server IP address simulator
46
43, 57
Database
50
Simulator database
Simulator Database special characters
SPI
FS
31
VT
31
13
SubTestType SurePath
8
8
-TTCP/IP client
4
TCP/IP server
4
Test Type
6, 8
50
50
42
timeout
6, 58
Timeout (Results) Transformer
17
4
transmit results
54
-UUniTrans
8
Urine UniTrans
8
-WWarning
13
Work Order
6
Work order inquiry timeout Workflow
58
6
Personal notes:
19-Mar-10
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