4800HI

cobas® 4800 system
Host Interface Manual

Software Version 2.1
Document Version 1.1
COBAS and LIFE NEEDS ANSWERS are trademarks of Roche.
©2012-2014 Roche
Roche Diagnostics
9115 Hague Rd
P.O. Box 50457
Indianapolis, IN 46250-0457
USA
www.roche.com
www.usdiagnostics.roche.com
General Information
The contents of this document, including all graphics and photographs, are the property of Roche. 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.
Every effort has been made to ensure that the information contained in this manual is accurate at the time
of printing. Not all functionality described in this manual may be available to all users. Roche Diagnostics
reserves the right to make any further required changes to software without prior notice. Such changes may
not immediately be reflected in this document.
Any screenshots in this publication have been added exclusively for the purpose of illustration. Configurable
and variable data such as parameters, results, path names etc. visible therein must not be used for laboratory
purposes.
This document is intended for the US market only.
This host interface description was created by Roche GmbH (manual content) and the Roche Diagnostics
Engineering Operations department. Direct questions or concerns regarding the contents of this document to:
Roche Diagnostics Corporation

Engineering Operations Department
9115 Hague Road
P.O. Box 50457
Indianapolis, IN 46250-0457
USA
COBAS, COBAS X, COBAS Z, LIGHTCYCLER and LIFE NEEDS ANSWERS are trademarks of Roche.
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©201, Roche Diagnostics. All right reserved.

5398-00-0814
Distribution in USA by: Roche Diagnostics, Indianapolis, IN
This document is available on the Roche Diagnostics USA website at www.usdiagnostics.roche.com
cobas® 4800 system Host Interface Manual, Software Version 2.1 i

Version 1.1
Revision History
Revisions to this document are provided by Roche when necessary. No part of this document may be reproduced
in any form or by any means without prior written consent.
Publication Reference Number Date Revision purpose

5398-00-0814
August 2014 First US release
Version 1.1
ii cobas® 4800 system Host Interface Manual, Software Version 2.1

Version 1.1
Application Code Number (ACN) Disclaimer for US Customers
Due to the increasing complexity of laboratories and the increase in types of test being
run, it is critical to use unique host download codes for each test when mapping codes on
your Laboratory Information System (LIS). It is also strongly recommended to use alpha or
alphanumeric codes on your LIS. If unique LIS test codes are not used when mapping on the
LIS, this could cause a test result from one test to be reported for a different test.
Required actions when using this host interface manual:
• Ensure that the LIS test codes mapped to your LIS are unique for each test.
• Always identify the instrument source of the results on your LIS.
cobas® 4800 system Host Interface Manual, Software Version 2.1 1

Version 1.1
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2 cobas® 4800 system Host Interface Manual, Software Version 2.1

Version 1.1
cobas® 4800 system
Host Interface Manual
Software Version 2.1.0

Document Version 1.1
cobas® 4800
Document information
Revision history Manual version Revision date Changes

1.0 September 2013 First Version
1.1 April 2014 CT/NG Mapping Tables corrected
Edition notice The intended audience for this manual is Host Interface programmers and the Roche
Field engineers supporting the system
Every effort has been made to ensure that all the information contained in this
manual is correct at the time of printing. Roche reserves the right to make any
changes necessary without notice as part of ongoing product development.
Any customer modification to the analyzer will render the warranty or service
agreement null and void.
Intended use The cobas® 4800 system is intended to be used as a diagnostic or screening system
providing sample preparation, amplification and detection of specific targets from
human samples. It is to be used by laboratory professionals trained in laboratory
techniques and the use of the system.
Copyright © 2013, Roche Diagnostics International Ltd. All rights reserved.
Trademarks The following trademarks are acknowledged:

cobas, cobas z, LightCycler and LIFE NEEDS ANSWERS are trademarks of Roche.
All other trademarks are the property of their respective owners.
Contact addresses Roche Molecular Systems, Inc.

1080 US Highway 202 South
Branchburg, NJ 08876
USA
Questions or comments regarding the contents of this manual can be directed to the
address below.
Roche Diagnostics International Ltd

Global Customer Support
Forrenstrasse 2
6343 Rotkreuz
Switzerland
Web: www.roche-rotkreuz.com
E-mail: [email protected]
Roche Diagnostics
2 Host Interface Manual · Software Version 2.1.0 · Document Version 1.1
cobas® 4800
Table of contents
Document information 2 7 Cdiff - LIS Mapping

Table of contents 3 Specimens E–68
Preface 5 Controls E–68
Conventions used in this manual 5 Examples E–69
8 HSV 1 and 2 - LIS Mapping

Workflow Part A Specimens E–72
Controls E–72
1 Workflow Examples E–73
Overview A–10
Communication Scenario A–11 9 MRSA/SA - LIS Mapping
Known Restrictions A–13 Specimens E–78
Controls E–79
Examples E–80
Record Definition Part B
10 BRAF - LIS Mapping
2 cobas 4800 ASTM Record Definition Specimens E–84
ASTM Information Flow Overview B–18 Controls E–84
Message Structure B–18 Examples E–85
Work Order Query Mapping
(Query from cobas 4800 LIS) B–21 11 EGFR P1- LIS Mapping
Work Order Response Specimens E–90
(Order download from LIS cobas 4800) B–23 Controls E–91
Work Order Denial Examples E–92
(Denial from cobas 4800 LIS) B–28
Result Output mapping 12 EGFR P2- LIS Mapping
(Result upload from cobas 4800 LIS) B–32 Specimens E–98
Controls E–99
Examples E–100
Software Configuration Part C
13 KRAS P1- LIS Mapping
3 cobas® 4800 Software Configuration Specimens E–106
System Settings C–44 Controls E–106
Examples E–107
Troubleshooting Part D 14 KRAS P2- LIS Mapping
Specimens E–114
4 Log Files/Troubleshooting Controls E–114
Logfiles D–50 Examples E–115
Troubleshooting D–51
Test Specific Mapping Tables Part E
5 CT/NG - LIS Mapping

Specimens E–56
Controls E–56
Examples E–57
6 HPV - LIS Mapping

Specimens E–62
Controls E–62
Examples E–63
Roche Diagnostics
Host Interface Manual · Software Version 2.1.0 · Document Version 1.1 3
cobas® 4800
Roche Diagnostics
4 Host Interface Manual · Software Version 2.1.0 · Document Version 1.1
cobas® 4800
Preface
The document is a basis for development the communication between the cobas®
4800 software, release 2.1.0 and Laboratory Information Systems (LIS) by using the
ASTM/CLSI communication protocols.
This document covers the generic structure of the communication between the
cobas® 4800 Software and the LIS. Customer supported Laboratory Information
System are not part of the cobas® 4800 package.
Conventions used in this manual
Symbols The following symbols are used:
Symbol Used for

a Start of procedure
End of procedure
o List item
e Cross-reference
Tip
Communication from cobas 4800 to LIS
Communication from LIS to cobas 4800
Abbreviations The following abbreviations are used:
Abbreviation Description
ACN Application Code Number ACN. LOINC standard for test codes to be used, if possible. Else use
99ROC for Roche ACN
ASTM American Society for Testing and Materials, now ASTM International
CLS Clinical and Laboratory Standards Institute
GUID A GUID is a 128-bit integer (16 bytes) that can be used across all computers and networks
wherever a unique identifier is required. Such an identifier has a very low probability of being
duplicated.
The value of a GUID is represented as a 32-character hexadecimal string, such as {21EC2020-
3AEA-1069-A2DD-08002B30309D}.
LIS/LIMS Laboratory Information Systen/ Laboratory Information Management System
NCCLS National Committee for Clinical Laboratory Standards, now CLSI
OSI Open Systems Interconnection (OSI) Model (ISO/IEC 7498-1)
Roche Diagnostics
Host Interface Manual · Software Version 2.1.0 · Document Version 1.1 5
cobas® 4800
Roche Diagnostics 6
Host Interface Manual · Software Version 2.1.0 · Document Version 1.1
Workflow A
cobas® 4800
Roche Diagnostics
A-8 Host Interface Manual · Software Version 2.1.0 · Document Version 1.1
cobas® 4800 1 Workflow
Table of contents
Workflow
In this chapter Chapter 1

Overview ......................................................................................................................... A–10
Work Order request (For Full Workflow Only): ................................................ A–10
Test result upload (For Full Workflow and PCR Only Workflow): ................ A–10
Communication Scenario ............................................................................................ A–11
Work Order Inquiry ............................................................................................... A–11
Work Order Download .......................................................................................... A–11
Additional information for Work Order Download: ........................................ A–11
Work Order Inquiry (Denial from cobas 4800 to LIS) ...................................... A–12
Result Upload .......................................................................................................... A–12
Known Restrictions ...................................................................................................... A–13
Character limitations .............................................................................................. A–13
Recovery run ............................................................................................................ A–13
Roche Diagnostics
Host Interface Manual · Software Version 2.1.0 · Document Version 1.1 A-9
1 Workflow cobas® 4800
Overview
Overview
The LIS interface service interacts between cobas 4800 and LIS in only one direction:
cobas 4800 initiates the communication to the LIS. LIS is configured as the server.
The supported scenarios are as follows:
Work Order request (For Full Workflow Only):
1 Request from cobas 4800 to LIS

2 Order download from LIS to cobas 4800
Test result upload (For Full Workflow and PCR Only Workflow):
1 Upload of test results and control results cobas 4800 to LIS
Roche Diagnostics
Communication Scenario
Work Order Inquiry
Part of Description Info from cobas 4800 to LIS

Work Order request The cobas 4800 asks the LIS to get Specimen ID. 
order details for one or more Inquiry is sent for each specimen.
specimens
Table A-1 Work Order Inquiry (Query)
Work Order Download
Part of Description Response from LIS to cobas 4800

Work Order request The LIS sends order information for  For each Specimen:
request LIS test order and Specimen Type, if
multiple orders for one specimen exist
they are all sent for that specimen.
Table A-2 Work Order Download (Response)
Additional information for Work Order Download:
cobas® 4800 Software sends an inquiry for one specimen and expects to receive an
answer for this specimen.
Two or more order requests for If more than one order for one specimen ID are available, all the orders for this
the same specimen ID: specimen ID have to be sent in the same message. The test order for a specimen ID
corresponding to the selected test type will be accepted by the cobas® 4800 Software.
Two or more test requests for the If more than one test within an order is sent to cobas® 4800 Software only the first one
same specimen ID: corresponding to the selected tests is accepted.
Roche Diagnostics
The following situations will lead to a rejected work order inquiry:
Requested test is not available or In the event the LIS sends orders to the cobas® 4800 Software for tests or subtests
activated in cobas® 4800: which are not available or activated.
Requested test does not match In the event the LIS sends an order for tests or subtests which are activated in the
the run started in cobas® 4800: cobas® 4800 Software, but are not a part of the current run.
Requested test has incorrect In the event the LIS sends an order for a specimen with the wrong or unsupported
Specimen type: specimen type.
Order request from LIS: In the event the LIS sends an order request which is not requested by the cobas® 4800
software.
Work Order Inquiry (Denial from cobas 4800 to LIS)

Denial of test The cobas 4800 sends order For each Specimen:
information for request cobas 4800 sends denial of not
matching or additional matching tests

Table A-3 : Workorder Inquiry (Denial from cobas 4800 to LIS)
Result Upload

Test Result Upload The cobas 4800 System sends the test Run Type, Test Type, Sub-Test Type,
results of a Run to the LIS Specimen Type, Test Result, Flags,
Sample ID, Test Time Stamp, Order
Time Stamp, Accepted Flag, MWP ID,
MWP position and DWP ID
Table A-4 Result Upload
"Result request from LIS: The LIS may not initiate a result request to cobas® 4800. This will be denied by cobas®
4800 either for Unaccepted or for Accepted results.
Roche Diagnostics
Known Restrictions
Known Restrictions
Character limitations
The characters | \ ^ & are used as delimiters and are not configurable.
Any character used as a delimiter should not be used in sample barcodes, or any
manual text entry field (e.g. Comments).
Recovery run
The cobas® 4800 Software allow users to recover runs following specific instrument
issues (See Operator's Manual for more details). If the results from the failed run were
previously uploaded (results = Failed) these orders may need to be reopened in the
LIS to allow the new results to be uploaded. The results from a recovery run will
display flag M5 in the comment field of the result upload (Field C-4-2) for each R-
segment and add an entry "C" in the R-9 field for each R-record/segment.
Roche Diagnostics
Known Restrictions
Roche Diagnostics
Record Definition B
2 cobas® 4800
Roche Diagnostics
B-16 Host Interface Manual · Software Version 2.1.0 · Document Version 1.1
cobas® 4800 2 cobas 4800 ASTM Record Definition
Table of contents
cobas 4800 ASTM Record Definition

ASTM Information Flow Overview ............................................................................B–18
Message Structure ..........................................................................................................B–18
Work Order Query Message Structure .................................................................B–18
Work Order Download (Response) Message Structure .....................................B–19
Work Order Denial Message Structure ................................................................B–19
Test Result Upload ...................................................................................................B–19
Work Order Query Mapping (Query from cobas 4800 LIS) ..................................B–21
H Record ...................................................................................................................B–21
Q Record ...................................................................................................................B–22
L Record ....................................................................................................................B–22
Example: Work Order Query (Query from cobas 4800 LIS) ............................B–22
Work Order Response (Order download from LIS cobas 4800) ............................B–23
H Record ...................................................................................................................B–23
P Record ....................................................................................................................B–24
O Record ...................................................................................................................B–25
L Record ....................................................................................................................B–26
Example: Work Order Response (Order download from LIS cobas 4800) ....B–26
Work Order Denial (Denial from cobas 4800 LIS) ..................................................B–28
H Record ...................................................................................................................B–28
P Record ....................................................................................................................B–29
O Record ...................................................................................................................B–30
L Record ....................................................................................................................B–31
Example: Work Order Denial (Denial from cobas 4800 LIS) ..........................B–31
Result Output mapping (Result upload from cobas 4800 LIS) ................................B–32
H Record ...................................................................................................................B–32
P Record ....................................................................................................................B–33
O Record ...................................................................................................................B–34
C Record (Order) .....................................................................................................B–35
R Record ....................................................................................................................B–36
C Record (Result) .....................................................................................................B–37
L Record ....................................................................................................................B–38
Example: Result Upload (Result upload from cobas 4800 LIS) .........................B–38
Roche Diagnostics
Host Interface Manual · Software Version 2.1.0 · Document Version 1.1 B-17
2 cobas 4800 ASTM Record Definition cobas® 4800
ASTM Information Flow Overview
ASTM Information Flow Overview
Figure B-1 ASTM Information Flow Overview
Message Structure
Work Order Query Message Structure
Record Code Record Name

H Message Header Record (ASTM: 7/NCCLS: 6)
 Q Request information record (ASTM: 12/NCCLS: 11)
L  Terminator Record (ASTM: 13/NCCLS: 12)
Table B-1 ASTM Work Order Query
There will always be only ONE Q-Record for each Specimen Id. Every specimen ID
is queried separately.
Roche Diagnostics
Message Structure
Work Order Download (Response) Message Structure

 P Patient information Record (ASTM:8/NCCLS. 7)
 only generic Patient (P|1) is sent, no detailed Patient information

 O Order record (ASTM: 9/NCCLS: 8)

Table B-2 ASTM Work Order Response
LIS might send multiple test orders for one specimen by using separate Patient
information and Order Records, only the first adequate order is accepted by the
cobas 4800, others are ignored
Work Order Denial Message Structure



Table B-3 ASTM Denial from cobas 4800 to LIS
LIS might send multiple test orders for one specimen by using separate Patient
information and Order Records, only the first adequate order is accepted by the
cobas 4800, others are ignored
Test Result Upload


Table B-4 ASTM Message Structure, Test Result Upload
Roche Diagnostics
Message Structure

 C Comment Record (ASTM: 11/NCCLS: 10)
 Specimen Comment
 R Result Record (ASTM: 10/NCCLS: 9)
 Result comment: Flags
Result comment: Control data (only controls)
 R Result Record (ASTM: 10/NCCLS: 9)
 Result comment: Flags
Result comment: Control data (only controls)
Table B-4 ASTM Message Structure, Test Result Upload
Roche Diagnostics
Work Order Query Mapping (Query from cobas 4800 LIS)
H Record
Record Name Type Description Values

and Number
H-1 String Record Type ID: H

The character H identifies the record as a
message header record
H-2 Delimiter Definition: |\^&
Field, Repetition, component and Escape
delimiter – exactly in this order
H-5-1 String Sender Name or ID: Name of the sending cobas 4800 software
application ^00000000-0000-0000-
0000-
000000001111ÛserID^2.
1.0.0000^1394.LIS2
H-5-2 GUID Sender Name or ID: cobas 4800 software
GUID representing the unique identifier of this ^00000000-0000-0000-
message given from the cobas 4800 software 0000-
000000001111ÛserID^2
.1.0.0000^1394.LIS2
H-5-3 String Sender Name or ID: cobas 4800 software
The name or shortcut of the user which create ^00000000-0000-0000-
the message 0000-
000000001111ÛserID^2.
1.0.0000^1394.LIS2
The version of the sending software ^00000000-0000-0000-
0000-
000000001111ÛserID^2.
1.0.0000^1394.LIS2
H-5-5 Number Sender Name or ID: cobas 4800 software
Protocol version – used as a version check to ^00000000-0000-0000-
make sure that this message is interpreted 0000-
correctly 000000001111ÛserID^2.
1.0.0000^1394.LIS2
H-10 String Receiver ID: LIS
Name of the application which has to receive
this message
H-11-1 String Message type TSREQ^REAL
used to delegate the tasks to the analyzer
Table B-5 H record - Work Order Query
Roche Diagnostics

and Number
H-11-2 String Event trigger TSREQ^REAL

H-12 String Processing ID (processing priority) P
P = Production
H-13 Number Version number (currently a constant number 1
set to 1)
H-14 DateTime DateTime of the message put by the creating YYYYMMDDhhmmss
system on creation of this message
Table B-5 H record - Work Order Query
Q Record

and Number
Q-1 String Record Type ID Q
Q-2 Number Sequence Number 1
Will always be 1, since there will be always only
one inquiry per message
Q-3-2 String Specimen ID ^BarcodeID
Table B-6 Q record - Work Order Query Mapping
L Record

and Number
L-1 String Record Type ID L
L-2 Number Sequence Number 1
L-3 Char Termination code N
(N = normal termination)
Table B-7 L record - Work Order Query Mapping
Example: Work Order Query (Query from cobas 4800 LIS)
Order query for one specimen (All segments will be sent for each barcode ID).
H|\^&|||cobas 4800 software^00000000-0000-0000-0000-000000001111Ûse-

rID^2.1.0.0000^1394.LIS2|||||LIS|TSREQ^REAL|P|1|YYYYMMDDhhmmss
Q|1|^BarcodeID
L|1|N
Roche Diagnostics
Work Order Response (Order download from LIS cobas 4800)
H Record

and Number

H-2 String Delimiter Definition: |\^&
delimiter – exactly in this order.
H-5-1 String Sender Name or ID: Name of the sending LIS
application ^00000000-0000-0000-
0000-
000000001114ÛserID^0.
0.0.0^1394.LIS2
H-5-2 GUID Sender Name or ID: LIS
message given from the LIS 0000-
000000001114ÛserID^0
.0.0.0^1394.LIS2
H-5-3 String Sender Name or ID: LIS
User which create the message ^00000000-0000-0000-
0000-
000000001114ÛserID^0.
0.0.0^1394.LIS2
H-5-4 String Sender Name or ID: LIS
Version of the sending software ^00000000-0000-0000-
0000-
000000001114ÛserID^0.
0.0.0^1394.LIS2
H-5-5 Number Sender Name or ID: LIS
0.0.0^1394.LIS2
H-10 String Receiver ID: cobas 4800
this message
H-11-1 String Message type used to delegate the tasks to the TSDWN^REAL
analyzer
Table B-8 H record - Work Order Response Mapping
Roche Diagnostics

and Number
H-11-2 String Event trigger used to delegate the tasks to the TSDWN^REAL
analyzer
H-12 String Processing mode (processing priority) P
P = Production
set to 1)
Table B-8 H record - Work Order Response Mapping
P Record

and Number
P-1 String Record Type P
P-2 Number Sequence Number 1
Table B-9 P record - Work Order Response Mapping
Sending of patient detailed information is prohibited by requirement. The cobas®

4800 software does not support any patient detailed information, but it appears in
trace files if sent. Therefore a generic patient record has to be sent
Roche Diagnostics
O Record
Record Name Type Comment Values

and Number
O-1 String Record Type ID O
O-2 Number Sequence Number 1
Note: LIS might send multiple test orders for
one specimen by using separate Order Records
O|1, O|2, …, only first adequate is accepted by
cobas 4800.
O-3-1 String Specimen ID: BarcodeID
Barcode ID assigned to the specimen
O-5-4 String Universal Test ID (LIS Order code): ^^^LISOrderCode^^Full
The exact test that the LIS must place in the
order.
See Test Specific LIS Mapping table in test-

specific Host Interface Manuals for complete
list of supported LIS Order codes.
O-5-6 String Run Type: ^^^LISOrderCode^^Full
Identifies the run type of the specimen
Allowed values are:

Full = Full run of all system components
(cobas x 480 and cobas z 480)
O-8 DateTime Specimen Collection Date and Time: YYYYMMDDhhmmss
Contents the Date/Time when the order was
created.
O-12 String Action Code ActionCode
N = New order
O-15 DateTime Date/Time when order was received YYYYMMDDhhmmss
O-16-1 String Media Source: Specimen Type. SpecimenType^P

list of Specimen types.
Note: For PCR only tests this field is empty.
Table B-10 O record - Work Order Response Mapping
Roche Diagnostics

and Number
O-16-2 String Media Source: SpecimenType^P
P = Patient
O-17 String Ordering Physician: UserID
Contents the user who has created the order
O-26 String Report Types ReportType
O = Order Record; user asking that analysis be

performed
Y = no Order on Record for this test
Table B-10 O record - Work Order Response Mapping
For missing orders the Host must send (besides O-1 and O-2) at least the O-3-1
component with the Specimen ID and O-26 field with "Y".
L Record

and Number
L-2 int Sequence Number 1
Table B-11 L Record - Work Order Response Mapping
Example: Work Order Response (Order download from LIS cobas 4800)
Example 1:
Response for a specimen with one order available.
H|\^&|||LIS^00000000-0000-0000-0000-000000001114ÛserID^0.0.0.0^1394.LIS2|||||cobas
4800|TSDWN^REAL|P|1|YYYYMMDDhhmmss
P|1
O|1|BarcodeID1||^^^LISOrderCode^^RunType|||YYYYMMDDhhmmss||||ActionCode|||YYYYMMDDhhmm
ss|SpecimenType^P|UserID|||||||||ReportType
L|1|N
Roche Diagnostics
Example 2:
Response for a specimen with multiples orders available. In this case the order with
the LISOrderCode corresponding to the test previously selected in the cobas® 4800
Software will be accepted and the other order will be ignored.
H|\^&|||LIS^00000000-0000-0000-0000-000000001114ÛserID^0.0.0.0^1394.LIS2|||||cobas
4800|TSDWN^REAL|P|1|YYYYMMDDhhmmss
P|1
O|1|BarcodeID1||^^^LISOrderCode1^^RunType|||YYYYMMDDhhmmss||||ActionCode|||YYYYMMDDhhm
mss|SpecimenType^P|UserID|||||||||ReportType
P|2
O|1|BarcodeID1||^^^LISOrderCode2^^RunType|||YYYYMMDDhhmmss||||ActionCode|||YYYYMMDDhhm
mss|SpecimenType^P|UserID|||||||||ReportType
L|1|N
Example 3:
Missing Order
H|\^&|||LIS^00000000-0000-0000-0000-000000001116ÛserID^0.0.0.1^1394.LIS2|
||||cobas 4800|TSDWN^REAL|P|1|YYYYMMDDhhmmss
P|1
O|1|BarcodeID1||^^^^^RunType|||YYYYMMDDhhmmss||||N||||||||||||||Y
L|1|N
Roche Diagnostics
Work Order Denial (Denial from cobas 4800 LIS)
H Record

and Number

H-2 Delimiter Definition: |\^&
application ^00000000-0000-0000-
0000-
000000001111ÛserID^2.
1.0.0000^1394.LIS2
000000001111ÛserID^2
.1.0.0000^1394.LIS2
The name or shortcut of the user which create ^00000000-0000-0000-
the message 0000-
000000001111ÛserID^2.
1.0.0000^1394.LIS2
The version of the sending software ^00000000-0000-0000-
0000-
000000001111ÛserID^2.
1.0.0000^1394.LIS2
1.0.0000^1394.LIS2
this message
H-11-1 String Message type TSDWN^REAL
Table B-12 H record - Work Order Denial Mapping
Roche Diagnostics

and Number
H-11-2 String Event trigger TSDWN^REAL

H-12 String Processing ID (processing priority) P
P = Production
set to 1)
Table B-12 H record - Work Order Denial Mapping
P Record

and Number
Table B-13 P record - Work Order Denial Mapping
Sending of patient detailed information is prohibited by requirement. The cobas

trace files if sent. Therefore a generic patient record has to be sent
Roche Diagnostics
O Record

and Number
Note: LIS might send multiple test orders for
one specimen by using separate Order Records
O|1, O|2, …, only first adequate is accepted by
cobas 4800, others are refused.
O-3-1 String Specimen ID: BarcodeID
Barcode ID assigned to the specimen
O-5-6 String Run Type: ^^^^^Full
Identifies the run type of the specimen
Allowed values are:

created.
N = New order
X = Order cannot be processed

Table B-14 O record - Work Order Denial Mapping
Roche Diagnostics
L Record

and Number
Table B-15 L Record - Work Order Response Mapping
Example: Work Order Denial (Denial from cobas 4800 LIS)
Example
Order query denied by LIS.

rID^0.0.0.0^1394.LIS2|||||LIS|RSUPL^REAL|P|1|YYYYMMDDhhmmss
P|1
O|1|BarcodeID1||^^^^^RunType|||YYYYMMDDhhmmss||||ActionCode||||||||||||||X
L|1|N
Roche Diagnostics
Result Output mapping (Result upload from cobas 4800 LIS)
H Record

and Number

H-2 String Delimiter Definition: |\^&
Note: Standard (ASCII 124, 92, 94, 38).
application ^00000000-0000-0000-
0000-
000000001120ÛserID^2.
1.0.0000^1394.LIS2
000000001120ÛserID^2
.1.0.0000^1394.LIS2
User which create the message ^00000000-0000-0000-
0000-
000000001120ÛserID^2.
1.0.0000^1394.LIS2
Version of the sending software ^00000000-0000-0000-
0000-
000000001120ÛserID^2.
1.0.0000^1394.LIS2
1.0.0000^1394.LIS2
this message
H-11-1 String Message type used to delegate the tasks to the RSUPL^REAL
analyzer
Table B-16 H record - Result Output Mapping
Roche Diagnostics

and Number
H-11-2 String Event trigger used to delegate the tasks to the RSUPL^REAL
analyzer
H-12 String Processing mode (processing priority) P
P = Production
set to 1)
H-14 DateTime DateTime of the message YYYYMMDDhhmmss
Table B-16 H record - Result Output Mapping
P Record

and Number
(Max for one run = 96)
Table B-17 P record - Result Output Mapping
Sending of patient detailed information is prohibited by requirement. The cobas

trace files if sent. Therefore a generic patient record has to be sent.
Roche Diagnostics
O Record

and Number
O-3-1 String Specimen ID: BarcodeID^
Unique identifier of the sample MWPBarcode
ID^MWPPos^^^DWPBa
(Barcode assigned to the sample: Specimen ID
rcodeID
or Control ID)
MWPBarcode
ID^MWPPos^^^DWPBa
MWP-Plate ID
rcodeID
MWPBarcode
MWP Position. ID^MWPPos^^^DWPBa
Note: This Position may be separated by a colon rcodeID
(:) in case of a multiwell test. (e.g. A06:A07:A08)
O-3-6 String Specimen ID: DWP Plate ID BarcodeID^
MWPBarcode
ID^MWPPos^^^DWPBa
rcodeID
O-5-4 String Universal Test ID: ^^^LISOrderCode^^Run
The exact test that the LIS must place in the Type
order.

list of of LIS order codes.
O-5-6 String Universal Test ID: ^^^LISOrderCode^^Run
Identifies the run type of the specimen Type
Allowed values are:

AnD = Amplification and Detection only (cobas
z 480)
created.
N = New order
Q = Control
O-15 DateTime Date/Time when order was received YYYYMMDDhhmmss
Table B-18 O record - Result Output Mapping
Roche Diagnostics

and Number
O-16-1 String Specimen Type Specimen:
SpecimenType^Specimen
Specimen: See Test Specific LIS Mapping table Role
in test-specific Host Interface Manuals for
complete list of Specimen Types. Control:
<Empty>^SpecimenRole
Control: this field is empty
O-16-2 String Media Source: Specimen:
SpecimenType^Specimen
Specimen : P (fixed value) Role
Controls: See Test Specific LIS Mapping table Control:

in test-specific Host Interface Manuals for ^SpecimenRole
complete list of Specimen Roles.
O-17 String User ID: Contents the user who has created the UserID
order
P = preliminary results
F = final results
Table B-18 O record - Result Output Mapping
C Record (Order)

and Number
C-1 String Record Type ID C
C-2 Number Sequence Number 1
(cobas 4800 SW supports only one comment for
the specimen)
C-3 String Comment Source I
C-4 String Comment Text: CommentText
Sample Comment, entered by the user during
Full workflow or in Result View
C-5 String Comment type: G
G = Generic
Table B-19 C record - Result Output Mapping (Optional: the C Record is not sent if no comment for specimen.)
Roche Diagnostics
R Record

and Number
R-1 String Record Type ID R
R-2 Number Sequence Number 1, 2, …n
For each order which is transmitted a number is
set starting from 1 to n (depending on the total
number of results for the respective test)
Note: G&O tests provide only test result (as1)
and the detected mutations (as 2, 3, …, n) for a
sample
R-3-4 String Universal Test ID ^^^ResultCode
Contains the name of a result name of a test.

list of result codes.
R-4 String Data or Measurement Value: Result value. ResultText

list of Result Texts.
The string can have only one value, in case of
Controls (VALID, INVALID) or two values in
case of specimen. Then the second value is the
name of the result of the test.
R-5 String Units: UnitValue
(Used for quantitative tests only, else empty)
R-9 String Result Status: ResultStatus
F: Final, result was accepted
P: Preliminary, result was not accepted
C: Corrected, Recovery Workflow
X: Failed
R-11 String Operator Identification UserID
User who has run the test
R-12 DateTime Date/Time Test Started YYYYMMDDhhmmss
Time when the test was started on the
instrument
R-13 DateTime Date/Time Test Completed YYYYMMDDhhmmss
Time when the test was finished on the
instrument
R-14 String Instrument Identification z480SN_BlockSN
Table B-20 R record - Result Output Mapping
Roche Diagnostics
C Record (Result)

and Number
C-2 Number Sequence Number: 1
Always “1”
C-4-1 String Comment Text F;NONE
F for Flags or
Always “F” followed by comma-separated list of
F;Flag1,Flag2
flags or NONE if no flags present
G: Generic comment
Table B-21 C record - Result Output Mapping - flags (for specimens)

and Number
C-2 Number Sequence Number: 2
Always “1”
C-4-1 String Comment Text: Ct:ChID1 (MMx 1),XX.X;
Semicolon-separated list of pairs: Ct:ChID2 (MMx 1),XX.X;
Ct:Channel ID (Master Mix),Ct value Ct:ChID3 (MMx 1),XX.X
Note: Up to four channels can be displayed, see

Test Specific LIS Mapping for the expected
channels.
(--- : indicates no Ct value for this channel)
Note: PCR only tests in this field only display a

comma (,)
G: Generic comment
Table B-22 C record - Result Output Mapping - Ct values (for controls only)
The C Record for control values is not sent for PCR only workflows.
Roche Diagnostics
L Record

and Number
Table B-23 L record - Result Output Mapping
Example: Result Upload (Result upload from cobas 4800 LIS)
Example 1:
Control and specimens

rID^0.0.0.0000^1394.LIS2|||||LIS|RSUPL^REAL|P|1|YYYYMMDDhhmmss
P|1
O|1|CtrlBarcodeID1^MWPBarcodeID^MWPPos^^^DWPBarcodeID||^^^LISOrderCode^^RunType|||2012
0427123100||||ActionCode|||YYYYMMDDhhmmss|^ControlName1|UserID|||||||||ReportType
C|1|I||G
R|1|^^^ResultCode1|Valid|Unit||||ResultStatus||UserID|YYYYMMDDhhmmss|YYYYMMD-
Dhhmmss|z480SN_BlockSN
C|1|I|F;Flag1|G
C|2|I|Ct:ChID1 (MMx 1),XX.X;Ct:ChID2 (MMx 1), XX.X;Ct:ChID3 (MMx 1), XX.X|G
C|1|I|F;Flag1|G
C|2|I|Ct:ChID1 (MMx 1), XX.X;Ct:ChID2 (MMx 1), XX.X;Ct:ChID3 (MMx 1), XX.X|G
P|2
O|1|CtrlBarcodeID2^MWPBarcodeID^MWPPos^^^DWPBarcodeID||^^^LISOrderCode^^RunType|||2012
0427123100||||ActionCode|||YYYYMMDDhhmmss|^ControlName2|UserID|||||||||ReportType
C|1|I||G
C|1|I|F;Flag1|G
C|2|I|Ct:0 (MMx 1),XX.X;Ct:1 (MMx 1), XX.X;Ct:5 (MMx 1), XX.X|G
Roche Diagnostics
C|1|I|F;Flag1|G
C|2|I|Ct:0 (MMx 1), XX.X;Ct:1 (MMx 1), XX.X;Ct:5 (MMx 1), XX.X|G
P|3
O|1|BarcodeID1^MWPBarcodeID^MWPPos^^^DWPBarcodeID||^^^TestCode^^RunType||| YYYYMMD-
Dhhmmss||||ActionCode|||YYYYMMDDhhmmss|MediaType^P|UserID|||||||||ReportType
C|1|I|CommentSample1|G
R|1|^^^ResultCode1|ResultText|Unit||||ResultStatus||UserID|YYYYMMDDhhmmss|YYYYMMD-
C|1|I|F;Flag1|G
If mutliple sub-test are ordered a R segment will be generated for each sub-
test
R|2|^^^ResultCode2|ResultText|Unit||||ResultStatus||UserID|YYYYMMDDhhmmss|YYYYMMD-
C|1|I|F;Flag1|G
Roche Diagnostics
Roche Diagnostics
Software Configuration C
3 cobas® 4800
Roche Diagnostics
C-42 Host Interface Manual · Software Version 2.1.0 · Document Version 1.1
cobas® 4800 3 cobas® 4800 Software Configuration
Table of contents
cobas® 4800 Software Configuration

System Settings .............................................................................................................. C–44
Roche Diagnostics
Host Interface Manual · Software Version 2.1.0 · Document Version 1.1 C-43
3 cobas® 4800 Software Configuration cobas® 4800
System Settings
System Settings
To configure the LIS communications settings go to: Utilities > Configuration >
System settings
Refer to the cobas®4800 system System Installation Manual for more information
regarding the LIS configuration.
Figure C-1 cobas® 4800 System Settings
Roche Diagnostics
cobas® 4800 3 cobas® 4800 Software Configuration
System Settings
Parameters Comment/Description
LIS connection was configured. Enable LIS connection (Default: un-checked)
o This field activates/deactivates the LIS communication
LIS Host Query Mode Configure whether LIS operates in Host Query Mode (Default: un-checked)
o This field is used to configure the behavior of the communication:
O "If checked, the software will query the LIS for specimen information
after the loading process.
O "If un-checked, the software will require specimen information to be
entered manually after the loading process.
LIS timeout LIS connection timeout (in seconds). (Default: 30 sec)
o This field specifies the maximum time allowed for each response from
the LIS server before initiating a timeout error.
Note: The configurable LIS timeout settings is for each sample query
message individually. The total timeout may not exceed 60 seconds
(Configured LIS Timeout(s) * Number of Samples).
Maximum number of LIS connection Configure the maximum number of retries for LIS connection (Default: 3)
retries o This field specifies the number of retries the software will attempt when
the communication to the LIS server is lost.
HL7 acknowledgement enabled Do not enable. This option is not used with the current software version.
Upload only accepted Test Results to Configure whether the Result upload to LIS shall only contain accepted results.
LIS (Default: checked)
o This field specifies whether all results or only the results that were
marked as Accepted are sent to the LIS server.
Note: Results for controls are always sent, even if not Accepted.
Table C-1 LIS configuration
Roche Diagnostics
Host Interface Manual · Software Version 2.1.0 · Document Version 1.1 C-45
3 cobas® 4800 Software Configuration cobas® 4800
System Settings
Roche Diagnostics
Troubleshooting D
4 cobas® 4800
Roche Diagnostics
D-48 Host Interface Manual · Software Version 2.1.0 · Document Version 1.1
cobas® 4800 4 Log Files/Troubleshooting
Table of contents
Log Files/Troubleshooting

Logfiles ............................................................................................................................ D–50
Communication Server Log .................................................................................. D–50
cobas® 4800 Software Session Log ........................................................................ D–50
Troubleshooting ............................................................................................................ D–51
Missing order for a single specimen ..................................................................... D–51
Missing order for all specimens ............................................................................ D–52
Roche Diagnostics
Host Interface Manual · Software Version 2.1.0 · Document Version 1.1 D-49
4 Log Files/Troubleshooting cobas® 4800
Logfiles
Logfiles
The log files needed to troubleshoot any issues are located in the following folders:
Communication Server Log
This file captures the specific information communicated between the

cobas® 4800 Software <> communication server <> LIS.
Directory: C:\Program Files\RocheDiagnosticsAG\Communication Server\LOG
Filename: cobas4800.log
cobas® 4800 Software Session Log
This file captures all the cobas® 4800 software actions/events.
Directory: C:\Program Files\Roche\c4800\Log
Filename: cobas-4800-session-trace-file.log
To find information regarding an error open the file with Windows Notepad and
search for |ERROR|. You may find some limited indications about protocol errors
(e.g, an incorrect type or missing mandatory parameter).
Roche Diagnostics
cobas® 4800 4 Log Files/Troubleshooting
Troubleshooting
Troubleshooting
Missing order for a single specimen
The following error is displayed when a specimen is loaded in cobas x 480 but there is
no corresponding order in the LIS:
Figure D-1 Missing Order for a single specimen
Roche Diagnostics
Host Interface Manual · Software Version 2.1.0 · Document Version 1.1 D-51
4 Log Files/Troubleshooting cobas® 4800
Troubleshooting
Missing order for all specimens
The following error is displayed when there are no orders in the LIS for any
specimens loaded:
Figure D-2 Missing order for all specimen
Roche Diagnostics
Test Specific Mapping Tables E
5 cobas® 4800
Roche Diagnostics
E-54 Host Interface Manual · Software Version 2.1.0 · Document Version 1.1
cobas® 4800 5 CT/NG - LIS Mapping
Table of contents
CT/NG - LIS Mapping

Specimens ........................................................................................................................E–56
Controls ...........................................................................................................................E–56
Examples .........................................................................................................................E–57
Order Query .............................................................................................................E–57
Order Response ........................................................................................................E–57
Result Output (POS, NEG, and Specimen) ..........................................................E–58
Specimen with single result output .......................................................................E–58
Specimen with multiple result outputs .................................................................E–59
Failed specimen with multiple result outputs ......................................................E–59
Failed specimen with single result output ............................................................E–59
Roche Diagnostics
Host Interface Manual · Software Version 2.1.0 · Document Version 1.1 E-55
5 CT/NG - LIS Mapping cobas® 4800
Specimens
Specimens
Parameters Comment/Description Parameters Comment/Description Parameters
POS CT
NEG CT
01CT
Invalid CT
SWAB
Failed
01CTNG URINE P
POS NG
PCYT
NEG NG
01NG
Invalid NG
Failed
SWAB POS CT
NEG CT
01CT URINE P 01CT
Invalid CT
PCYT Failed
SWAB POS NG
NEG NG
01NG URINE P 01NG
Invalid NG
PCYT Failed
Table E-1 CT/NG Specimen
PCYT = PreservCyt® cytology media
Controls
Specimen Role
LISOrderCode SpecimenType ResultCode ResultText
(ASTM)
01CT
Positive Control POSCONTROL Valid
01NG
01CTNG Invalid
01CT
Negative Control NEGCONTROL Failed
01NG
Table E-2 CT/NG Controls
Roche Diagnostics
Examples
Examples
Order Query
H|\^&|||cobas 4800^c1876daf-af05-4bb8-bc92-8edba42475c1^RocheNo-
Check^^1394.LIS2|||||LIS|TSREQ^REAL|P|1|20130402170751
Q|1|^BC000005
L|1|N
Order Response
H|\^&|||ASTM32^b422404e-7269-4ca1-9f13-cca1e04abaf2^MTSIN-
STALL^7.6.5^1394.LIS2|||||cobas 4800|TSDWN^REAL|P|1|20130623141557|
P|1
O|1|BC000005||^^^01CTNG^^Full|||20130401124500||||N|||20130401105500|SWAB^P|Use-
rID|||||||||O
L|1|N
Roche Diagnostics
Examples
Result Output (POS, NEG, and Specimen)
H|\^&|||cobas 4800 software^dcaf4724-e7c8-4976-9d4e-2e15beb9f4f9^Labopera-

tor^2.1.0.1314^1394.LIS2|||||LIS|RSUPL^REAL|P|1|20130405174405
P|1
O|1|1C1R108089E0FTTÊD0906895Â01^^^BA0803617||^^^01CTNG^^Full|||20130214114700||||Q||
||^POSCONTROL|Laboperator|||||||||P
R|1|^^^01CT|Valid|||||P||Laboperator|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
C|2|I|Ct:0 (MMx 1),37.5;Ct:1 (MMx 1),37.7;Ct:5 (MMx 1),37.5|G
R|2|^^^01NG|Valid|||||P||Laboperator|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
P|2
O|1|0NCR100197E0J80ÊD0906895^B01^^^BA0803617||^^^01CTNG^^Full|||20130214114700||||Q||
||^NEGCONTROL|Laboperator|||||||||P
R|1|^^^01CT|Valid|||||P||Laboperator|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
C|2|I|Ct:0 (MMx 1),---;Ct:1 (MMx 1),---;Ct:5 (MMx 1),37.5|G
R|2|^^^01NG|Valid|||||P||Laboperator|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
Specimen with single result output
P|3
O|1|A2194474ÊD0906895^C01^^^BA0803617||^^^01CT^^Full|||20130214114700||||N||||PCYT^P|
Laboperator|||||||||P
C|1|I|Media|G
R|1|^^^01CT|NEG CT|||||P||Laboperator|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
P|4
O|1|A2194475ÊD0906895^D01^^^BA0803617||^^^01NG^^Full|||20130214114700||||N||||PCYT^P|
R|1|^^^01NG|NEG NG|||||P||Laboperator|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
Roche Diagnostics
Examples
Specimen with multiple result outputs
P|4
O|1|A2194761ÊD0906895Â02^^^BA0803617||^^^01CTNG^^Full|||20130214114700||||N||||PCYT^
P|Laboperator|||||||||P
C|1|I|Media|G
R|1|^^^01CT|NEG CT|||||P||Laboperator|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
R|2|^^^01NG|NEG NG|||||P||Laboperator|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
Failed specimen with multiple result outputs
P|5
O|1|A2192909ÊD0802831^C01^^^BA0803621||^^^01CTNG^^Full|||20130211120256||||N||||PCYT^
C|1|I|Empty Tube|G
R|1|^^^01CT|Failed|||||P||Laboperator|20130211122448|20130211151237|51049_31253
C|1|I|F;X4,M7|G
R|2|^^^01NG|Failed|||||P||Laboperator|20130211122448|20130211151237|51049_31253
C|1|I|F;X4,M7|G
Failed specimen with single result output
P|6
O|1|A2192909ÊD0802831^C01^^^BA0803621||^^^01NG^^Full|||20130211120256||||N||||PCYT^P|
C|1|I|Empty Tube|G
R|1|^^^01NG|Failed|||||P||Laboperator|20130211122448|20130211151237|51049_31253
C|1|I|F;X4,M7|G
Roche Diagnostics
Examples
Roche Diagnostics
cobas® 4800 6 HPV - LIS Mapping
Table of contents
HPV - LIS Mapping

Specimens ........................................................................................................................E–62
Controls ...........................................................................................................................E–62
Examples .........................................................................................................................E–63
Order Query .............................................................................................................E–63
Order Response ........................................................................................................E–63
Roche Diagnostics
6 HPV - LIS Mapping cobas® 4800
Specimens
Specimens
Specimen Role
(ASTM)
POS Other HR HPV
NEG Other HR HPV
02HPVOHR Invalid Other HR
HPV
Failed
POS HPV16
PCYT
02HPVGEN P NEG HPV16
SPATH 02HPV16
Invalid HPV16
Failed
POS HPV18
NEG HPV18
02HPV18
Invalid HPV18
Failed
POS HR HPV
PCYT NEG HR HPV
02HPVPAN P 02HPVHR
SPATH Invalid HR HPV
Failed
Table E-3 HPV Specimen
PCYT = PreservCyt® cytology media

SPATH = SurePath™ cytology media
Controls
Specimen Role
(ASTM)
02HPVOHR
Positive Control POSCONTROL 02HPV16
Valid
02HPV18
02HPV Invalid
02HPVOHR
Failed
Negative Control NEGCONTROL 02HPV16
02HPV18
Table E-4 HPV Controls
Roche Diagnostics
Examples
Examples
Order Query
H|\^&|||cobas 4800^c1876daf-af05-4bb8-bc92-8edba42475c1Ûse-
rID^^1394.LIS2|||||LIS|TSREQ^REAL|P|1|20130402170751
Q|1|^BC000005
L|1|N
Order Response
H|\^&|||ASTM32^0097c1b3-fd48-4595-8b6b-0ad7012a01c9^MTSIN-
P|1
O|1|BC000005||^^^02HPVGEN^^Full|||20130401124500||||N|||20130401105500|SPATH^P|Use-
rID|||||||||O
L|1|N
Roche Diagnostics
Examples
H|\^&|||cobas 4800 software^dcaf4724-e7c8-4976-9d4e-2e15beb9f4f9^Labopera-

P|1
O|1|2H1R103477D00FCÊD0906895Â01^^^BA0803617||^^^02HPV^^Full|||20130214114700||||Q|||
|^POSCONTROL|Laboperator|||||||||P
R|1|^^^02HPVOHR|Valid|||||P||UserID|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
C|2|I|Ct:0 (MMx 1),37.5;Ct:1 (MMx 1),37.7;Ct:3 (MMx 1),39.2;Ct:5 (MMx 1),37.5|G
R|2|^^^02HPV16|Valid|||||P||UserID|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
C|1|I|F;M7,M8|G
P|2
O|1|0NCR100197E0J80ÊD0906895^B01^^^BA0803617||^^^02HPV^^Full|||20130214114700||||Q|||
|^NEGCONTROL|Laboperator|||||||||P
R|1|^^^02HPVOHR|Valid|||||P||UserID|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
C|2|I|Ct:0 (MMx 1),---;Ct:1 (MMx 1),---;Ct:3 (MMx 1),---;Ct:5 (MMx 1),---|G
C|1|I|F;M7,M8|G
C|1|I|F;M7,M8|G
P|3
O|1|A2194474ÊD0906895^C01^^^BA0803617||^^^02HPVPAN^^Full|||20130214114700||||N||||PCY
T^P|UserID|||||||||P
R|1|^^^02HPVHR|NEG HR HPV|||||P||UserID|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
Roche Diagnostics
Examples
P|4
O|1|A2194761ÊD0906895Â02^^^BA0803617||^^^02HPVGEN^^Full|||20130214114700||||N||||SPA
TH^P|UserID|||||||||P
R|1|^^^02HPVOHR|NEG Other HR HPV|||||P||Use-
rID|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
R|2|^^^02HPV16|NEG HPV16|||||P||UserID|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
R|3|^^^02HPV18|NEG HPV18|||||P||UserID|20130214115242|20130214153414|51049_31253
C|1|I|F;M7,M8|G
P|5
O|1|A2192909ÊD0802831^C01^^^BA0803621||^^^02HPVGEN^^Full|||20130211120256||||N||||PCY
T^P|Laboperator|||||||||P
C|1|I|Empty Tube|G
R|1|^^^02HPVOHR|Failed|||||P||Laboperator|20130211122448|20130211151237|51049_31253
C|1|I|F;X4,M7|G
R|2|^^^02HPV16|Failed|||||P||Laboperator|20130211122448|20130211151237|51049_31253
C|1|I|F;X4,M7|G
R|3|^^^02HPV18|Failed|||||P||Laboperator|20130211122448|20130211151237|51049_31253
C|1|I|F;X4,M7|G
P|6
O|1|A2192909ÊD0802831^C01^^^BA0803621||^^^02HPVPAN^^Full|||20130211120256||||N||||PCY
T^P|Laboperator|||||||||P
C|1|I|Empty Tube|G
R|1|^^^02HPVHR|Failed|||||P||Laboperator|20130211122448|20130211151237|51049_31253
C|1|I|F;X4,M7|G
Roche Diagnostics
Examples
Roche Diagnostics
cobas® 4800 7 Cdiff - LIS Mapping
Table of contents
Cdiff - LIS Mapping

Specimens ........................................................................................................................E–68
Controls ...........................................................................................................................E–68
Examples .........................................................................................................................E–69
Order Query .............................................................................................................E–69
Order Response ........................................................................................................E–69
Roche Diagnostics
7 Cdiff - LIS Mapping cobas® 4800
Specimens
Specimens
Specimen Role
(ASTM)
Substance
Identifier (HL-7)
POS Cdiff
NEG Cdiff
04CDIFF STL P 04CDIFF Invalid Cdiff
Failed
Indeterminate Cdiff
Table E-5 Cdiff Specimens
STL = Stool
Controls
Specimen Role
(ASTM)
LISOrderCode Control Type ResultCode ResultText
Substance
Identifier (HL-7)
Positive Control POSCONTROL Valid

04CDIFF 04CDIFF Invalid
Negative Control NEGCONTROL Failed
Table E-6 Cdiff Controls
Roche Diagnostics
cobas® 4800 7 Cdiff - LIS Mapping
Examples
Examples
Order Query
H|\^&|||cobas 4800 software^ 1d022c60-60ea-4d04-b023-4d0b539d6871^Labopera-

tor^2.1.0.1324^1394.LIS2|||||LIS|TSREQ^REAL|P|1|20130317115122
Q|1|Â3059230
L|1|N
Order Response
H|\^&|||ASTM32^ 1d022c60-60ea-4d04-b023-4d0b539d6871^ MTSIN-

P|1
O|1|A3059230||^^^04CDIFF^^Full|||20130317115122||||N|||20121116113305|STL^P|Use-
rID|||||||||O
L|1|N
H|\^&|||cobas 4800 software^14cc06c5-8ba7-44b5-b0ef-e8cef626d17eÛse-

rID^2.1.0.1324^1394.LIS2|||||LIS|RSUPL^REAL|P|1|20130317115122\
P|1
O|1|4PC000SYS0Z0131ÊD0206944^C08^^^BA0803892||^^^04CDIFF^^Full|||20130317115122||||Q|
|||^POSCONTROL|UserID|||||||||P
R|1|^^^04CDIFF|Valid|||||F||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
P|2
O|1|0NCP122453D0TD1ÊD0206944^D08^^^BA0803892||^^^04CDIFF^^Full|||20130317115122||||Q|
|||^NEGCONTROL|UserID|||||||||P
R|1|^^^04CDIFF|Valid|||||F||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
Roche Diagnostics
7 Cdiff - LIS Mapping cobas® 4800
Examples
P|3
O|1|A3059230ÊD0206944Ê08^^^BA0803892||^^^04CDIFF^^Full|||20130317115122||||N||||STL^
P|UserID|||||||||P
R|1|^^^04CDIFF|POS Cdiff|||||P||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
P|4
O|1|A3060042ÊD0206944^F08^^^BA0803892||^^^04CDIFF^^Full|||20130317115122||||N||||STL^
P|UserID|||||||||P
R|1|^^^04CDIFF|NEG Cdiff|||||P||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
P|5
O|1|A2192909ÊD0802831^C01^^^BA0803621||^^^04CDIFF^^Full|||20130211120256||||N||||STL^
C|1|I|Empty Tube|G
R|1|^^^04CDIFF|Failed|||||P||Laboperator|20130211122448|20130211151237|51049_31253
C|1|I|F;X4,M7|G
L|1|N
Roche Diagnostics
cobas® 4800 8 HSV 1 and 2 - LIS Mapping
Table of contents
HSV 1 and 2 - LIS Mapping

Specimens ........................................................................................................................E–72
Controls ...........................................................................................................................E–72
Examples .........................................................................................................................E–73
Order Query .............................................................................................................E–73
Order Response ........................................................................................................E–73
Failed specimen with multiple result output .......................................................E–75
Roche Diagnostics
8 HSV 1 and 2 - LIS Mapping cobas® 4800
Specimens
Specimens
Specimen Role
(ASTM)
Substance
Identifier (HL-7)
Failed
POS HSV-1
05HSV1 NEG HSV-1
Invalid HSV-1
Indeterminate HSV-1
05HSV12 ASWAB P
Failed
POS HSV-2
05HSV2 NEG HSV-2
Invalid HSV-2
Indeterminate HSV-2
Table E-7 HSV 1 and HSV 2 Specimen
ASWAB = Anogenital Swab
Controls
Specimen Role
(ASTM)
Substance
Identifier (HL-7)
Positive Control POSCONTROL 05HSV1
Valid
04CDIFF
05HSV2 Invalid
Failed
Negative Control NEGCONTROL 05HSV1
05HSV2
Table E-8 HSV 1 and 2 Controls
Roche Diagnostics
Examples
Examples
Order Query

Q|1|Â3059230
L|1|N
Order Response
H|\^&|||ASTM32^1d022c60-60ea-4d04-b023-4d0b539d6871^ MTSIN-
P|1
O|1|A3059230||^^^05HSV12^^Full|||20130317115122||||N|||20121116113305|ASWAB^P|Use-
rID|||||||||O
L|1|N
Roche Diagnostics
Examples

rID^2.1.0.1324^1394.LIS2|||||LIS|RSUPL^REAL|P|1|20130317115122
P|1
O|1|5PC000SYS0Z0131ÊD0206944^C08^^^BA0803892||^^^05HSV12^^Full|||20130317115122||||Q|
|||^POSCONTROL|UserID|||||||||P
R|1|^^^05HSV1|Valid|||||F||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
C|1|I|F;M7|G
P|2
O|1|0NCP122453D0TD1ÊD0206944^D08^^^BA0803892||^^^05HSV12^^Full|||20130317115122||||Q|
|||^NEGCONTROL|UserID|||||||||P
C|1|I|F;M7|G
C|1|I|F;M7|G
P|3
O|1|A3059230ÊD0206944Ê08^^^BA0803892||^^^05HSV12^^Full|||20130317115122||||N||||ASWA
B^P|UserID|||||||||P
R|1|^^^05HSV1|POS HSV-1|||||P||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
R|2|^^^05HSV2|POS HSV-2|||||P||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
P|4
O|1|A3060042ÊD0206944^F08^^^BA0803892||^^^05HSV12^^Full|||20130317115122||||N||||ASWA
B^P|UserID|||||||||P
R|1|^^^05HSV1|NEG HSV-1|||||P||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
R|2|^^^05HSV2|NEG HSV-2|||||P||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
L|1|N
Roche Diagnostics
Examples
Failed specimen with multiple result output
P|5
O|1|A2192909ÊD0802831^C01^^^BA0803621||^^^05HSV12^^Full|||20130211120256||||N||||ASWA
B^P|Laboperator|||||||||P
C|1|I|Empty Tube|G
R|1|^^^05HSV1|Failed|||||P||Laboperator|20130211122448|20130211151237|51049_31253
C|1|I|F;X4,M7|G
R|2|^^^05HSV2|Failed|||||P||Laboperator|20130211122448|20130211151237|51049_31253
C|1|I|F;X4,M7|G
Roche Diagnostics
Examples
Roche Diagnostics
cobas® 4800 9 MRSA/SA - LIS Mapping
Table of contents
MRSA/SA - LIS Mapping

Specimens ........................................................................................................................E–78
Controls ...........................................................................................................................E–79
Examples .........................................................................................................................E–80
Order Query .............................................................................................................E–80
Order Response ........................................................................................................E–80
Roche Diagnostics
9 MRSA/SA - LIS Mapping cobas® 4800
Specimens
Specimens
Specimen Role
(ASTM)
Substance
Identifier (HL-7)
Failed
POS MRSA
03MRSA NEG MRSA
Invalid MRSA
Indeterminate MRSA
03MRSASA NSWAB P
Failed
POS SA
03SA NEG SA
Invalid SA
Indeterminate SA
Failed
POS MRSA
03MRSA NSWAB P 03MRSA NEG MRSA
Invalid MRSA
Indeterminate MRSA
Failed
POS SA
03SA NSWAB P 03SA NEG SA
Invalid SA
Indeterminate SA
Table E-9 MRSA/SA Specimen
NSWAB = Nasal Swab
Roche Diagnostics
Controls
Controls
Specimen Role
(ASTM)
Substance
Identifier (HL-7)
Positive Control POSCONTROL 03MRSA
Valid
03MRSASA 03SA Invalid
Failed
Negative Control NEGCONTROL 03MRSA
03SA
Table E-10 MRSA/SA Controls
Roche Diagnostics
Examples
Examples
Order Query

Q|1|Â3059230
L|1|N
Order Response
H|\^&|||ASTM32^1d022c60-60ea-4d04-b023-4d0b539d6871^ MTSIN-
P|1
O|1|A3059230||^^^03MRSA^^Full|||20130317115122||||N|||20121116113305|NSWAB^P|Use-
rID|||||||||O
L|1|N
Roche Diagnostics
Examples

rID^2.1.0.1324^1394.LIS2|||||LIS|RSUPL^REAL|P|1|20130317115122
P|1
O|1|3PC000SYS0Z0131ÊD0206944^C08^^^BA0803892||^^^03MRSASA^^Full|||20130317115122||||Q
||||^POSCONTROL|UserID|||||||||P
R|1|^^^03MRSA|Valid|||||F||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
R|2|^^^03SA|Valid|||||F||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
P|2
O|1|0NCP122453D0TD1ÊD0206944^D08^^^BA0803892||^^^03MRSASA^^Full|||20130317115122||||Q
||||^NEGCONTROL|UserID|||||||||P
R|1|^^^03MRSA|Valid|||||F||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
R|2|^^^03SA|Valid|||||F||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
P|3
O|1|A3059230ÊD0206944Ê08^^^BA0803892||^^^03SA^^Full|||20130317115122||||N||||NSWAB^P
|UserID|||||||||P
R|1|^^^03SA|POS SA|||||P||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
Roche Diagnostics
Examples
P|4
O|1|A3060042ÊD0206944^F08^^^BA0803892||^^^03MRSASA^^Full|||20130317115122||||N||||NSW
AB^P|UserID|||||||||P
R|1|^^^03MRSA|NEG MRSA|||||P||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
R|2|^^^03SA|POS SA|||||P||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
P|5
O|1|A3058754ÊD0206944^G08^^^BA0803892||^^^03MRSASA^^Full|||20130317115122||||N|||2013
1116113305|NSWAB^P|UserID|||||||||F
R|1|^^^03MRSA|POS MRSA|||||P||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
R|2|^^^03SA|NEG SA|||||P||UserID|20131116110709|20131116160310|518_25295
C|1|I|F;M7|G
L|1|N
P|6
O|1|A2192909ÊD0802831^C01^^^BA0803621||^^^03MRSASA^^Full|||20130211120256||||N||||NSW
AB^P|Laboperator|||||||||P
C|1|I|Empty Tube|G
R|1|^^^03MRSA|Failed|||||P||Laboperator|20130211122448|20130211151237|51049_31253
C|1|I|F;X4,M7|G
R|2|^^^03SA|Failed|||||P||Laboperator|20130211122448|20130211151237|51049_31253
C|1|I|F;X4,M7|G
P|7
O|1|A2192909ÊD0802831^C01^^^BA0803621||^^^03SA^^Full|||20130211120256||||N||||NSWAB^P
|Laboperator|||||||||P
C|1|I|Empty Tube|G
R|1|^^^03SA|Failed|||||P||Laboperator|20130211122448|20130211151237|51049_31253
C|1|I|F;X4,M7|G
Roche Diagnostics
cobas® 4800 10 BRAF - LIS Mapping
Table of contents
BRAF - LIS Mapping

Specimens ........................................................................................................................E–86
Controls ...........................................................................................................................E–86
Examples .........................................................................................................................E–87
Result Upload (Example 1) .....................................................................................E–87
Roche Diagnostics
10 BRAF - LIS Mapping cobas® 4800
Specimens
Specimens
TestCode Specimen Type Specimen Role ResultCode ResultText
Mutation Detected
No Mutation Detected
09BRAF [blank] P 09BRAF
Invalid
Failed
Table E-11 BRAF Specimens
Controls
Valid
MUTCONTROL 09BRAF Invalid
Failed
09BRAF [blank]
Valid
WTCONTROL 09BRAF Invalid
Failed
Table E-12 BRAF Controls
Roche Diagnostics
Examples
Examples
Result Upload (Example 1)
H|\^&|||cobas 4800 software^2f6105d5-9100-4f3b-9490-

d97ea3dda4eeÂdmin^2.1.0.1324^1394.LIS2|||||LIS|RSUPL^REAL|P|1|20130626114119
P|1
O|1|9A1123456BZ1234ÂD0000013Â01^^^||^^^09BRAF^ÂnD|||20130328130736||||Q||||^MUTCON-
TROL|Admin|||||||||P
R|1|^^^09BRAF|Valid|||||P||Admin|20130625150757|20130625150824|50977_31089
C|1|I|F;NONE|G
C|2|I|,|G
P|2
O|1|9A1123456BZ1234ÂD0000013^B01^^^||^^^09BRAF^ÂnD|||20130328130736||||Q||||^WTCON-
R|1|^^^09BRAF|Valid|||||P||Admin|20130625150757|20130625150824|50977_31089
C|1|I|F;NONE|G
C|2|I|,|G
P|3
O|1|s1ÂD0000013^C01^^^||^^^09BRAF^ÂnD|||20130328130736||||N||||^P|Admin|||||||||P
R|1|^^^09BRAF|Mutation Detected|||||P||Admin|20130625150757|20130625150824|50977_31089
C|1|I|F;NONE|G
P|4
R|1|^^^09BRAF|Invalid|||||P||Admin|20130625150757|20130625150824|50977_31089
C|1|I|F;NONE|G
Roche Diagnostics
Examples
H|\^&|||cobas 4800 software^dda20937-a0fc-4c9f-9d85-177b36ad1d6d^Labopera-

P|1
O|1|9A1P182776D0001ÊD0901464Â01^^^||^^^09BRAF^ÂnD|||20130522141418||||Q||||^MUTCON-
TROL|FSE|||||||||P
C|1|I|WT|G
R|1|^^^09BRAF|Invalid|||||P||FSE|20130522150121|20130522163553|50977_31089
C|1|I|F;R200|G
P|2
O|1|9A1P182776D0001ÊD0901464^B01^^^||^^^09BRAF^ÂnD|||20130522141418||||Q||||^WTCON-
TROL|FSE|||||||||P
C|1|I|WT|G
R|1|^^^09BRAF|Valid|||||P||FSE|20130522150121|20130522163553|50977_31089
C|1|I|F;NONE|G
P|3
O|1|MUTÊD0901464^C01^^^||^^^09BRAF^ÂnD|||20130522141418||||N||||^P|FSE|||||||||P
C|1|I|F;R200|G
P|4
O|1|WTÊD0901464^D01^^^||^^^09BRAF^ÂnD|||20130522141418||||N||||^P|FSE|||||||||P
C|1|I|F;R200|G
Roche Diagnostics
Examples
H|\^&|||cobas 4800 software^137017e4-9654-44aa-841c-

d0851a018335Âdmin^2.1.0.1324^1394.LIS2|||||LIS|RSUPL^REAL|P|1|20130626114128
P|1
O|1|9A1123456BZ1234ÂD0000015Â01^^^||^^^09BRAF^ÂnD|||20130328130736||||Q||||^MUTCON-
R|1|^^^09BRAF|Failed|||||P||Admin|20130625175245|20130625175252|50977_31089
C|1|I|F;M2|G
C|2|I|,|G
P|2
O|1|9A1123456BZ1234ÂD0000015^B01^^^||^^^09BRAF^ÂnD|||20130328130736||||Q||||^WTCON-
C|1|I|F;M2|G
C|2|I|,|G
P|3
C|1|I|F;M2|G
Roche Diagnostics
Examples
Roche Diagnostics
cobas® 4800 11 EGFR P1- LIS Mapping
Table of contents
EGFR P1- LIS Mapping

Specimens ........................................................................................................................E–93
Controls ...........................................................................................................................E–94
Examples .........................................................................................................................E–95
Roche Diagnostics
11 EGFR P1- LIS Mapping cobas® 4800
Specimens
Specimens
Mutation Detected
08EGFR
Invalid
Failed
08EGFR01 Exon 19 Deletion
08EGFR02 Exon 20 S768I
08EGFR03 Exon 21 L858R

08EGFR [blank] P
08EGFR04 Exon 20 T790M
08EGFR05 Exon 21 L861Q
08EGFR06 Exon 18 G719X
08EGFR07 Exon 20 Insertion
08EGFR08 N/A
Table E-13 EGFR P1 Specimens
Roche Diagnostics
Controls
Controls
Valid
08EGFR Invalid
MUTCONTROL Failed
08EGFR08 N/A
08EGFR [blank]
Valid
08EGFR Invalid
NEGCONTROL Failed
08EGFR08 N/A
Table E-14 EGFR P1 Controls
Roche Diagnostics
Examples
Examples
H|\^&|||cobas 4800 software^9e5add38-8340-4734-a62f-

20908871db51Âdmin^2.1.0.1324^1394.LIS2|||||LIS|RSUPL^REAL|P|1|20130626114509
P|1
O|1|8A1123456BZ1234ÂD0000124Â01:A02:A03^^^||^^^08EGFR^ÂnD|||20130318165129||||Q||||
^MUTCONTROL|Admin|||||||||P
R|1|^^^08EGFR|Valid|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
C|2|I|,|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
C|2|I|,|G
P|2
O|1|8A1123456BZ1234ÂD0000124^B01:B02:B03^^^||^^^08EGFR^ÂnD|||20130318165129||||Q||||
^NEGCONTROL|Admin|||||||||P
C|1|I|F;NONE|G
C|2|I|,|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
C|2|I|,|G
P|3
O|1|s2ÂD0000124^C01:C02:C03^^^||^^^08EGFR^ÂnD|||20130318165129||||N||||^P|Admin|||||
||||P
R|1|^^^08EGFR|No Mutation
Detected|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
Roche Diagnostics
Examples
P|4
O|1|s3ÂD0000124^D01:D02:D03^^^||^^^08EGFR^ÂnD|||20130318165129||||N||||^P|Admin|||||
||||P
R|1|^^^08EGFR|Mutation Detected|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
R|2|^^^08EGFR01|Exon 19 Dele-
tion|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
R|3|^^^08EGFR02|Exon 20 S768I|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
R|4|^^^08EGFR03|Exon 21 L858R|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
R|5|^^^08EGFR04|Exon 20 T790M|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
R|6|^^^08EGFR06|Exon 18 G719X|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
R|7|^^^08EGFR07|Exon 20 Inser-
tion|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
P|5
O|1|s4ÂD0000124Ê01:E02:E03^^^||^^^08EGFR^ÂnD|||20130318165129||||N||||^P|Admin|||||
||||P
R|1|^^^08EGFR|Invalid|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;R417|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;R417|G
Roche Diagnostics
Examples

P|1
C|1|I|F;NONE|G
C|2|I|,|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
C|2|I|,|G
P|2
C|1|I|F;R391|G
C|2|I|,|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;R391|G
C|2|I|,|G
P|3
||||P
C|1|I|F;R391|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;R391|G
Roche Diagnostics
Examples
H|\^&|||cobas 4800 software^0effb3d8-31a8-4796-ae0e-

3d4c06f338faÂdmin^2.1.0.1324^1394.LIS2|||||LIS|RSUPL^REAL|P|1|20130626114516
P|1
R|1|^^^08EGFR|Failed|||||P||Admin|20130626112111|20130626112119|51004_31170
C|1|I|F;M2|G
C|2|I|,|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112111|20130626112119|51004_31170
C|1|I|F;M2|G
C|2|I|,|G
P|2
C|1|I|F;M2|G
C|2|I|,|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112111|20130626112119|51004_31170
C|1|I|F;M2|G
C|2|I|,|G
P|3
||||P
C|1|I|F;M2|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112111|20130626112119|51004_31170
C|1|I|F;M2|G
Roche Diagnostics
Examples
Roche Diagnostics
Table of contents
EGFR P2- LIS Mapping

Specimens ......................................................................................................................E–101
Controls .........................................................................................................................E–102
Examples .......................................................................................................................E–103
Result Upload (Example 1) ...................................................................................E–103
Roche Diagnostics
Specimens
Specimens
Mutation Detected
08EGFR
Invalid
Failed
08EGFR01 Exon 19 Deletion
08EGFR02 Exon 20 S768I
08EGFR03 Exon 21 L858R

08EGFR [blank] P
08EGFR04 Exon 20 T790M
08EGFR05 Exon 21 L861Q
08EGFR06 Exon 18 G719X
08EGFR07 Exon 20 Insertion
08EGFR08 N/A
Table E-15 EGFR P2 Specimens
Roche Diagnostics
Controls
Controls
Valid
08EGFR Invalid
MUTCONTROL Failed
08EGFR08 N/A
08EGFR [blank]
Valid
08EGFR Invalid
NEGCONTROL Failed
08EGFR08 N/A
Table E-16 EGFR P2 Controls
Roche Diagnostics
Examples
Examples

P|1
C|1|I|F;NONE|G
C|2|I|,|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
C|2|I|,|G
P|2
C|1|I|F;NONE|G
C|2|I|,|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
C|2|I|,|G
P|3
||||P
R|1|^^^08EGFR|No Mutation
Detected|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112819|20130626112848|51004_31170
Roche Diagnostics
Examples
C|1|I|F;NONE|G
P|4
O|1|s3ÂD0000124^D01:D02:D03^^^||^^^08EGFR^ÂnD|||20130318165129||||N||||^P|Admin|||||
||||P
R|1|^^^08EGFR|Mutation Detected|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
R|2|^^^08EGFR01|Exon 19
Deletion|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
R|3|^^^08EGFR03|Exon 21 L858R|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
P|5
O|1|s4ÂD0000124Ê01:E02:E03^^^||^^^08EGFR^ÂnD|||20130318165129||||N||||^P|Admin|||||
||||P
C|1|I|F;R417|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;R417|G
Roche Diagnostics
Examples

P|1
C|1|I|F;NONE|G
C|2|I|,|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;NONE|G
C|2|I|,|G
P|2
C|1|I|F;R391|G
C|2|I|,|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;R391|G
C|2|I|,|G
P|3
||||P
C|1|I|F;R391|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112819|20130626112848|51004_31170
C|1|I|F;R391|G
Roche Diagnostics
Examples
H|\^&|||cobas 4800 software^0effb3d8-31a8-4796-ae0e-

3d4c06f338faÂdmin^2.1.0.1324^1394.LIS2|||||LIS|RSUPL^REAL|P|1|20130626114516
P|1
C|1|I|F;M2|G
C|2|I|,|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112111|20130626112119|51004_31170
C|1|I|F;M2|G
C|2|I|,|G
P|2
C|1|I|F;M2|G
C|2|I|,|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112111|20130626112119|51004_31170
C|1|I|F;M2|G
C|2|I|,|G
P|3
||||P
C|1|I|F;M2|G
R|2|^^^08EGFR08|N/A|||||P||Admin|20130626112111|20130626112119|51004_31170
C|1|I|F;M2|G
Roche Diagnostics
Examples
Roche Diagnostics
cobas® 4800 13 KRAS P1- LIS Mapping
Table of contents
KRAS P1- LIS Mapping

Specimens ......................................................................................................................E–106
Controls .........................................................................................................................E–106
Examples .......................................................................................................................E–107
Roche Diagnostics
13 KRAS P1- LIS Mapping cobas® 4800
Specimens
Specimens
Mutation Detected
07KRAS
Invalid
Failed
07KRAS [blank] P 07KRAS01 Codon 12/13
07KRAS02 Codon 61
07KRAS03 N/A
Table E-17 KRAS P1 Specimens
Controls
Valid
07KRAS Invalid
MUTCONTROL Failed
07KRAS03 N/A
Valid
07KRAS Invalid
08EGFR [blank] NEGCONTROL Failed
07KRAS03 N/A
Valid
07KRAS Invalid
CALIBRATOR Failed
07KRAS03 N/A
Table E-18 KRAS P1 Controls
Roche Diagnostics
Examples
Examples
H|\^&|||cobas 4800 software^ca9fd475-15c8-4dd0-9fad-

88bda5ffeedaÂdmin^2.1.0.1324^1394.LIS2|||||LIS|RSUPL^REAL|P|1|20130626114323
P|1
O|1|7A1123456BZ1234ÂD0000125Â01:A02^^^||^^^07KRAS^ÂnD|||20130328135416||||Q||||^MUT
CONTROL|Admin|||||||||P
R|1|^^^07KRAS|Valid|||||P||Admin|20130626113119|20130626113718|51004_31170
C|1|I|F;NONE|G
C|2|I|,|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626113119|20130626113718|51004_31170
C|1|I|F;NONE|G
C|2|I|,|G
P|2
O|1|7A1123456BZ1234ÂD0000125^B01:B02^^^||^^^07KRAS^ÂnD|||20130328135416||||Q||||^NEG
C|1|I|F;NONE|G
C|2|I|,|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626113119|20130626113718|51004_31170
C|1|I|F;NONE|G
C|2|I|,|G
P|3
O|1|7A1123456BZ1234ÂD0000125^C01:C02^^^||^^^07KRAS^ÂnD|||20130328135416||||Q||||^CAL
IBRATOR|Admin|||||||||P
C|1|I|F;NONE|G
C|2|I|,|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626113119|20130626113718|51004_31170
Roche Diagnostics
Examples
C|1|I|F;NONE|G
C|2|I|,|G
P|4
O|1|s1ÂD0000125^D01:D02^^^||^^^07KRAS^ÂnD|||20130328135416||||N||||^P|Admin|||||||||
P
R|1|^^^07KRAS|Invalid|||||P||Admin|20130626113119|20130626113718|51004_31170
C|1|I|F;R313|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626113119|20130626113718|51004_31170
C|1|I|F;R313|G
P|5
O|1|s2ÂD0000125Ê01:E02^^^||^^^07KRAS^ÂnD|||20130328135416||||N||||^P|Admin|||||||||
P
R|1|^^^07KRAS|Mutation Detected|||||P||Admin|20130626113119|20130626113718|51004_31170
C|1|I|F;NONE|G
R|2|^^^07KRAS01|Codon 12/13|||||P||Admin|20130626113119|20130626113718|51004_31170
C|1|I|F;NONE|G
R|3|^^^07KRAS02|Codon 61|||||P||Admin|20130626113119|20130626113718|51004_31170
C|1|I|F;NONE|G
Roche Diagnostics
Examples
H|\^&|||cobas 4800 software^5e0dfe8c-a8ba-4bb3-9e2a-fba30348943a^Labopera-

P|1
O|1|7A1KRASP10FU345ÊD0901466Â01:A02^^^||^^^07KRAS^ÂnD|||20130514163144||||Q||||^MUT
CONTROL|Laboperator|||||||||P
C|1|I|MC|G
R|1|^^^07KRAS|Invalid|||||P||Laboperator|20130514165921|20130514184825|51004_31170
C|1|I|F;R251,R261|G
C|2|I|,|G
R|2|^^^07KRAS03|N/A|||||P||Laboperator|20130514165921|20130514184825|51004_31170
C|1|I|F;R251,R261|G
C|2|I|,|G
P|2
O|1|7A1KRASP10FU345ÊD0901466^B01:B02^^^||^^^07KRAS^ÂnD|||20130514163144||||Q||||^NEG
C|1|I|NEG (SD)|G
C|2|I|,|G
R|1|^^^07KRAS|Valid|||||P||Laboperator|20130514165921|20130514184825|51004_31170
C|1|I|F;NONE|G
C|2|I|,|G
C|1|I|F;NONE|G
C|2|I|,|G
P|3
Roche Diagnostics
Examples
O|1|7A1KRASP10FU345ÊD0901466^C01:C02^^^||^^^07KRAS^ÂnD|||20130514163144||||Q||||^CAL
IBRATOR|Laboperator|||||||||P
C|1|I|Invalid Cal (SD)|G
C|1|I|F;R259,R269|G
C|2|I|,|G
C|1|I|F;R259,R269|G
C|2|I|,|G
P|4
O|1|01234567890123456789ÊD0901466^D01:D02^^^||^^^07KRAS^ÂnD|||20130514163144||||N|||
|^P|Laboperator|||||||||P
C|1|I|MD (Codon 12/13 + Codon 61)|G
C|1|I|F;R251,R259,R261,R269|G
C|1|I|F;R251,R259,R261,R269|G
Roche Diagnostics
Examples
H|\^&|||cobas 4800 software^d579adab-9130-4922-863b-

73b8125fe71cÂdmin^2.1.0.1324^1394.LIS2|||||LIS|RSUPL^REAL|P|1|20130626114333
P|1
R|1|^^^07KRAS|Failed|||||P||Admin|20130626112206|20130626112213|51004_31170
C|1|I|F;M2|G
C|2|I|,|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626112206|20130626112213|51004_31170
C|1|I|F;M2|G
C|2|I|,|G
P|2
C|1|I|F;M2|G
C|2|I|,|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626112206|20130626112213|51004_31170
C|1|I|F;M2|G
C|2|I|,|G
P|3
C|1|I|F;M2|G
C|2|I|,|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626112206|20130626112213|51004_31170
Roche Diagnostics
Examples
C|1|I|F;M2|G
C|2|I|,|G
P|4
P
C|1|I|F;M2|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626112206|20130626112213|51004_31170
C|1|I|F;M2|G
Roche Diagnostics
Table of contents
KRAS P2- LIS Mapping

Specimens ......................................................................................................................E–118
Controls .........................................................................................................................E–119
Examples .......................................................................................................................E–120
Roche Diagnostics
Specimens
Specimens
Mutation Detected
07KRAS
Invalid
Failed
07KRAS [blank] P 07KRAS01 Codon 12/13
07KRAS02 Codon 61
07KRAS03 N/A
Table E-19 KRAS P2 Specimens
Controls
Valid
07KRAS Invalid
MUTCONTROL Failed
07KRAS03 N/A
Valid
07KRAS Invalid
08EGFR [blank] NEGCONTROL Failed
07KRAS03 N/A
Valid
07KRAS Invalid
CALIBRATOR Failed
07KRAS03 N/A
Table E-20 KRAS P2 Controls
Roche Diagnostics
Examples
Examples
H|\^&|||cobas 4800 software^ca9fd475-15c8-4dd0-9fad-

88bda5ffeedaÂdmin^2.1.0.1324^1394.LIS2|||||LIS|RSUPL^REAL|P|1|20130626114323
P|1
C|1|I|F;NONE|G
C|2|I|,|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626113119|20130626113718|51004_31170
C|1|I|F;NONE|G
C|2|I|,|G
P|2
C|1|I|F;NONE|G
C|2|I|,|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626113119|20130626113718|51004_31170
C|1|I|F;NONE|G
C|2|I|,|G
P|3
C|1|I|F;NONE|G
C|2|I|,|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626113119|20130626113718|51004_31170
Roche Diagnostics
Examples
C|1|I|F;NONE|G
C|2|I|,|G
P|4
P
R|1|^^^07KRAS|Invalid|||||P||Admin|20130626113119|20130626113718|51004_31170
C|1|I|F;R313|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626113119|20130626113718|51004_31170
C|1|I|F;R313|G
P|5
O|1|s2ÂD0000125Ê01:E02^^^||^^^07KRAS^ÂnD|||20130328135416||||N||||^P|Admin|||||||||
P
R|1|^^^07KRAS|Mutation Detected|||||P||Admin|20130626113119|20130626113718|51004_31170
C|1|I|F;NONE|G
R|2|^^^07KRAS01|Codon 12/13|||||P||Admin|20130626113119|20130626113718|51004_31170
C|1|I|F;NONE|G
Roche Diagnostics
Examples
H|\^&|||cobas 4800 software^5e0dfe8c-a8ba-4bb3-9e2a-fba30348943a^Labopera-

P|1
O|1|7A1KRASP10FU345ÊD0901466Â01:A02^^^||^^^07KRAS^ÂnD|||20130514163144||||Q||||^MUT
C|1|I|MC|G
C|1|I|F;R251,R261|G
C|2|I|,|G
C|1|I|F;R251,R261|G
C|2|I|,|G
P|2
O|1|7A1KRASP10FU345ÊD0901466^B01:B02^^^||^^^07KRAS^ÂnD|||20130514163144||||Q||||^NEG
C|1|I|NEG (SD)|G
C|2|I|,|G
R|1|^^^07KRAS|Valid|||||P||Laboperator|20130514165921|20130514184825|51004_31170
C|1|I|F;NONE|G
C|2|I|,|G
C|1|I|F;NONE|G
C|2|I|,|G
P|3
Roche Diagnostics
Examples
O|1|7A1KRASP10FU345ÊD0901466^C01:C02^^^||^^^07KRAS^ÂnD|||20130514163144||||Q||||^CAL
IBRATOR|Laboperator|||||||||P
C|1|I|Invalid Cal (SD)|G
C|1|I|F;R259,R269|G
C|2|I|,|G
C|1|I|F;R259,R269|G
C|2|I|,|G
P|4
O|1|01234567890123456789ÊD0901466^D01:D02^^^||^^^07KRAS^ÂnD|||20130514163144||||N|||
|^P|Laboperator|||||||||P
C|1|I|MD (Codon 12/13)|G
C|1|I|F;R251,R259,R261,R269|G
C|1|I|F;R251,R259,R261,R269|G
Roche Diagnostics
Examples
H|\^&|||cobas 4800 software^d579adab-9130-4922-863b-

73b8125fe71cÂdmin^2.1.0.1324^1394.LIS2|||||LIS|RSUPL^REAL|P|1|20130626114333
P|1
C|1|I|F;M2|G
C|2|I|,|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626112206|20130626112213|51004_31170
C|1|I|F;M2|G
C|2|I|,|G
P|2
C|1|I|F;M2|G
C|2|I|,|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626112206|20130626112213|51004_31170
C|1|I|F;M2|G
C|2|I|,|G
P|3
C|1|I|F;M2|G
C|2|I|,|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626112206|20130626112213|51004_31170
C|1|I|F;M2|G
C|2|I|,|G
P|4
P
C|1|I|F;M2|G
R|2|^^^07KRAS03|N/A|||||P||Admin|20130626112206|20130626112213|51004_31170
C|1|I|F;M2|G
Roche Diagnostics
Examples
Roche Diagnostics

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cobas® 4800 system

Host Interface Manual

Roche Diagnostics Corporation

©201, Roche Diagnostics. All right reserved.

This document is available on the Roche Diagnostics USA website at www.usdiagnostics.roche.com

cobas® 4800 system Host Interface Manual, Software Version 2.1 i

Publication Reference Number Date Revision purpose

ii cobas® 4800 system Host Interface Manual, Software Version 2.1

cobas® 4800 system Host Interface Manual, Software Version 2.1 1

2 cobas® 4800 system Host Interface Manual, Software Version 2.1

Software Version 2.1.0

Revision history Manual version Revision date Changes

Copyright © 2013, Roche Diagnostics International Ltd. All rights reserved.

Trademarks The following trademarks are acknowledged:

Contact addresses Roche Molecular Systems, Inc.

Roche Diagnostics International Ltd

Document information 2 7 Cdiff - LIS Mapping

8 HSV 1 and 2 - LIS Mapping

Test Specific Mapping Tables Part E

5 CT/NG - LIS Mapping

6 HPV - LIS Mapping

Conventions used in this manual

Symbols The following symbols are used:

Symbol Used for

Communication from cobas 4800 to LIS

Communication from LIS to cobas 4800

Abbreviations The following abbreviations are used:

In this chapter Chapter 1

The supported scenarios are as follows:

Work Order request (For Full Workflow Only):

1 Request from cobas 4800 to LIS

1 Upload of test results and control results cobas 4800 to LIS

Work Order Inquiry

Part of Description Info from cobas 4800 to LIS

Work Order Download

Part of Description Response from LIS to cobas 4800

Additional information for Work Order Download:

The following situations will lead to a rejected work order inquiry:

Work Order Inquiry (Denial from cobas 4800 to LIS)

Part of Description Info from cobas 4800 to LIS

Part of Description Info from cobas 4800 to LIS

cobas 4800 ASTM Record Definition

In this chapter Chapter 2

ASTM Information Flow Overview

Figure B-1 ASTM Information Flow Overview

Work Order Query Message Structure

Record Code Record Name

Work Order Download (Response) Message Structure

Record Code Record Name

Work Order Denial Message Structure

Record Code Record Name

Test Result Upload

Record Code Record Name

Record Code Record Name

Work Order Query Mapping (Query from cobas 4800 LIS)

Record Name Type Description Values

H-1 String Record Type ID: H

Record Name Type Description Values

H-11-2 String Event trigger TSREQ^REAL

Record Name Type Description Values