Immunomat

Immunomat
Connectivity manual
Version 1.14/2018-09
Institut Virion\Serion GmbH Friedrich-Bergius-Ring 19, 97076 Würzburg, Germany

Phone +49 931 3045 0 Fax +49 931 3045 100 Mail [email protected] Web www.virion-serion.de
Contents
1 Introduction ............................................................................................ 4
1.1 Purpose ............................................................................................. 4
1.2 Scope................................................................................................. 4
1.3 Connectivity ....................................................................................... 4
1.4 ASTM Link Overview.......................................................................... 4
1.5 Procedure .......................................................................................... 5
2 ASTM Interface ....................................................................................... 6
2.1 Setup ................................................................................................. 6
2.2 Low-Level Protocol............................................................................. 8
2.2.1 Physical Layer ............................................................................. 8
2.2.2 Data Link Layer ........................................................................... 8
2.3 Logical Structure of the Message Level Protocol .............................. 10
2.4 Incoming and Outgoing Transmission Examples .............................. 11
2.4.1 Host to ImmunomatTM ................................................................ 11
2.4.2 Test Results............................................................................... 12
2.4.3 ImmunomatTM to Host ................................................................ 13
2.5 Data Record Usage.......................................................................... 16
2.5.1 Message Header Record ........................................................... 16
2.5.2 Patient Information Record ........................................................ 17
2.5.3 Test Order Record ..................................................................... 18
2.5.4 Result Record ............................................................................ 20
2.5.5 Comment Record....................................................................... 22
2.5.6 Request Information Record ...................................................... 22
2.5.7 Message Terminator Record ..................................................... 22
2.5.8 Scientific Record........................................................................ 22
2.5.9 Manufacturer Information Record .............................................. 22
2.6 LIMS Query for Test Order Requests ............................................... 23
2.7 Referenced Documents.................................................................... 24
3 ASCII File Transfer ............................................................................... 25
3.1 Introduction ...................................................................................... 25
3.2 Hardware Configurations.................................................................. 25
3.3 Manual Import of a Worklist .............................................................. 26
3.3.1 Import a Worklist File ................................................................. 26
3.3.2 Examples of Import files............................................................. 28
3.4 Automatic Import of a Worklist File ................................................... 30
3.4.1 File Polling ................................................................................. 30
3.4.2 Setup Polling ............................................................................. 30
4 Export of files ....................................................................................... 31
4.1 Directory for Export Files .................................................................. 31
4.2 Assay Definition for Export ............................................................... 32
4.2.1 Available Header and Data Fields.............................................. 34
4.3 Examples of Export Files.................................................................. 35
TM
Immunomat - Connectivity Manual Page 3
1 Introduction
1.1 Purpose
1 Introduction
1.1 Purpose
To describe the various methods of importing and exporting information or data for the
TM
Immunomat software.
1.2 Scope
Document includes description for the ASTM link, and ASCII file exchanges.
1.3 Connectivity
TM
The Immunomat has been designed to easily integrate into a laboratory
environment. It provides a variety of connection methods for importing and exporting
data. Imported data is for ASCII patient information that allows the system to create
worklists and download of worklists. It is not possible to import absorbance data,
pipette data or other file types from other systems or readers. Export data is for the
patient results in a variety of formats; the software supports a flexible format report
structure, that can create ASCII files as well as utilizing the ASTM link to up load
patient results.
1.4 ASTM Link Overview

This section is intended to document the interface for exchanging information between
TM
the Immunomat instrument and a host computer.
TM
Communication between the Immunomat and an external host computer consists
of receiving test requests from the host and reporting results back to the host. This is
accomplished via an RS232 connection and follows the ASTM 1394 (high level) and
1381 (low level) standards for communication.
TM
The Immunomat host interface consists of:
o ASTM 1381 low-level transfer protocol used to transmit or receive messages
o Interpretation of received data from the intermediate files and entering it into
TM
the Immunomat database
TM
The general procedure at the Immunomat related to communication with an
external host, as well as the specific implementation of the ASTM standards are
described here.
The ASTM 1394 defines how the data to be transmitted is represented as a structured
message consisting of several records. These messages are then translated into one
or more frames that will actually be transmitted.
TM
Page 4 Immunomat - Connectivity Manual
1 Introduction
1.5 Procedure
1.5 Procedure
TM
Immunomat communication sessions with a host computer can be initiated by
TM
sending the requests from the host computer to the Immunomat . An operator can
TM
upload test results on request through a Immunomat menu selection. The host may
also send test orders spontaneously.
All sample and test information, previously received from the host and downloaded to
TM TM
the Immunomat , will appear in the Immunomat ‘Patient Editor' dialog box. After a
test is performed, the results become available for transferring to the host computer.
An operator can upload results to the host.
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2 ASTM Interface
2.1 Setup
2 ASTM Interface
2.1 Setup
By means of the following Dialog the LIS interface can be customized:
1. ComPORT This field specifies the serial port used for host transmissions.
This must be different to the system COM Port.
2. BaudRate Specifies the Baudrate used for transmissions between the
TM
Immunomat and the host any values from 110 to 56,000 can
be chosen. Default is 9600.
3. DataBits 7 or 8, default is 7.
4. StopBits 1, 1.5 or 2, default is 1.
5. Parity None, odd, even, mark, space, default is None.
8. Delimiters These fields specify the set of delimiters used for transmissions.
7. ID Instrument ID is included in the result record.
8. Query Host The Query Host mode can be enabled with this field.
9. Compact Mode Each patient result information is send in one block or as
separate blocks.
10. Create Log File A log file (yyyymmdd.txt) of the ASTM communication is created
in the sub-directory Event log.
Table 2-1: Customizing
1. The ASTM setup dialog can be accessed from Utilities | Options menu.
2. Select the ASTM tab.
3. Check the entry 'Enable ASTM E 1381/1394 link to enable. The ASTM E 1394
delimiters could be configured as well as the ASTM E 1381 communication
ports.
4. Select the correct com ports.
Please make sure, that you must not select the port used to connect the PC to
the analyzer.
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2 ASTM Interface
2.1 Setup
Figure 2-1: ASTM configuration
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2 ASTM Interface
2.2 Low-Level Protocol
2.2.1 Physical Layer
Immunomat™
PC
Figure 2-2: RS232 Connection to Host
2.2.2 Data Link Layer

Establishment Refer to ASTM 1381, Section 6.2 (see 2.7 Referenced Documents).
Phase
Transfer Phase Refer to ASTM 1381, Section 6.3 (see 2.7 Referenced Documents).
The checksum is encoded as two characters sent after the <ETB> or <ETX>
character. The checksum includes the first character after <STX> (the frame number)
up to and including <ETB> or <ETX>. It is computed by adding the binary values of
the characters, keeping the least significant eight bits of the result.
During the transfer phase, if the LIS responds to a frame with an <EOT> the
TM
Immunomat does not stop transmitting and chooses to ignore the interrupt request.
Termination Refer to ASTM 1381, Section 6.4 (see 2.7 Referenced Documents).
Phase TM
After the Immunomat transmits or receives the <EOT>, indicating that all messages
have been sent, the line is considered to be in the neutral state.
Error Recovery Refer to ASTM 1381, Section 6.5 (see 2.7 Referenced Documents).
TM
The Immunomat checks every frame it receives to guarantee its validity and sends
an <ACK> for a valid frame, or a <NAK> for an invalid frame. Frames are invalidated
when:
o Any character errors are detected (ie. parity error, framing error)
o The frame checksum does not match the checksum computed on the
received frame.
o The frame number is not the same as the last accepted frame or one number
higher.
TM
When the Immunomat receives a <NAK> for a frame rejected by a host it resends
TM
the frame. If a single frame is sent and rejected six times, the Immunomat proceeds
to the termination phase.
TM
During the establishment phase, the Immunomat expects to receive a reply within
TM
15 seconds after sending <ENQ>. During the transfer phase, the Immunomat
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2 ASTM Interface
expects to receive a reply within 15 seconds after transmitting the last character of a
TM
frame. If a timeout occurs, the Immunomat proceeds to the termination phase.
TM
During the transfer phase, the Immunomat expects to receive a frame or <EOT>
within 30 seconds after first entering the transfer phase or replying to a frame. After a
timeout, the last incomplete message is discarded and the line is considered to be in
TM
the neutral state. The Immunomat will also timeout if a reply to a frame is not
received within 15 seconds.
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2 ASTM Interface
2.3 Logical Structure of the Message Level Protocol
2.3 Logical Structure of the Message Level

Protocol
The blocked stream of data sent between a host computer and the analyzer at a given
time is called a message.
Messages consist of a hierarchy of records of various types:
Level: Segment Name: Identifier Comments:
(Record TypeID):
0 Message Header Record ‘H’
0 Message Terminator Record ‘L’
1 Patient Information Record ‘P’
1 Request Information Segment ‘Q’
1 Scientific Record ‘S’
2 Test Order Record ‘O’
3 Result Record ‘R’
Common Comment Record ‘C’
1 Manufacturer Information Record ‘M’
Table 2-2: Logical Structure of the Message Level Protocol
A record is identified by the first field of a record, the RecordTypeID. Most of the
various record types are related to each other in a definite hierarchy. A lower level
record may never appear without the preceding higher level record. (Order records
must be preceded by a patient record, result records must be preceded by an order
record... ) A sequence of records at one level is terminated by the appearance of a
record of the same or higher level. (In some other descriptions a record might also be
called segment.)
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2 ASTM Interface
2.4 Incoming and Outgoing Transmission Examples
2.4 Incoming and Outgoing Transmission

Examples
2.4.1 Host to ImmunomatTM

Response from host includes patient demographics, patient ID, sample ID, and test
orders according to the following record hierarchy.
The response to requests for test orders is expected to be received within 10 seconds
after the request has been sent.
Structure defined by ASTM 1394 Structure defined by ASTM 1381
(multiple records comprise a single (each record is sent as one or more
message) frames)
Message Header Record
Patient Information Record 1
Test Order Record 1
:
Test Order Record n
: ► Frame 1
Patient Information Record n :
Test Order Record 1 Frame n
:
Test Order Record n
Message Terminator Record
Table 2-3: Structure of ASTM 1394 and ASTM 1381
In case there are no test orders available the LIS should respond with an empty
message containing header and terminator records only. The terminator record should
contain an ‘I’ (no information available) flag in the Termination Code Field.
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2 ASTM Interface
S:<ENQ>
R:<ACK>
S:<STX>1H|\^&|||LaborEDV||||||||1|19941115202738<CR><ETX><CR>
<LF>
R:<ACK>
S:<STX>2P|1|PatID01|42670070||MeierÂnna||19741001|F|||||
MARTINEZ<CR><ETX><CR><LF>
R:<ACK>
S:<STX>3O|1|||^^^HBsAg||20011115|||||||||S||||||||||X<CR><ETX>
<CR><LF>
R:<ACK>
S:<STX>4P|1|PatID02|43681136||Mueller^Fritz||19941001|M|||||
R:<ACK>
<CR><LF>
R:<ACK>
S:<STX>6P|1|PatID03|43691135||Otto^Hans||19941001|M|||||
R:<ACK>
<CR><LF>
R:<ACK>
S:<STX>0P|1|PatID04|00102105||Mayer^John||19941001|M|||||
R:<ACK>
<CR><LF>
R:<ACK>
S:<STX>4L|1|N<CR><ETX><CR><LF>
R:<ACK>
S:<EOT>
Table 2-4: Example

TM
After the Immunomat receives all test orders from the host, the records are
interpreted. Valid test orders are entered into the load list database, while invalid test
orders are not.
2.4.2 Test Results

Only the final calculated result (Abs, concentration or interpretation) is transferred per
test. For multiple replicate results the mean is transmitted only.
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2 ASTM Interface
2.4.3 ImmunomatTM to Host

Transmit sample information with corresponding tests and results.
Structure defined by ASTM 1394 Structure defined by ASTM 1381
(multiple records comprise a single (each record is sent as one or more
message) frames)
Message Header Record
Patient Information Record 1
Test Order Record 1
Result Record 1
Comment 1
:
Result Record n
Comment 1
:
Test Order Record n
Result Record 1
Comment 1
:
Result Record n
Comment 1 Frame 1
: ► :
Patient Information Record n Frame n
Test Order Record 1
Result Record 1
Comment 1
:
Result Record n
Comment 1
:
Test Order Record n
Result Record 1
Comment 1
:
Result Record n
Comment 1
Message Terminator Record
Table 2-5: Structure of ASTM 1394 and ASTM 1381
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2 ASTM Interface
R:<ENQ>
S:<ACK>
R:<STX>1H|\^&|||9163500014<CR><ETX>56<CR><LF>
S:<ACK>
R:<STX>2P|1||42670070||MeirÂnna||19740410|F<CR><ETX>48<CR><LF>
S:<ACK>
R:<STX>3O|1|||^^^HBsAg<CR><ETX>72<CR><LF>
S:<ACK>
R:<STX>4R|1|^^^HBsAg|0.059||<CR><ETX>EE<CR><LF>
S:<ACK>
R:<STX>5P|2||43681136||Mueller^Fritz||19940428|M<CR>
<ETX>3E<CR><LF>
S:<ACK>
R:<STX>6O|1|||^^^HBsAg<CR><ETX>75<CR><LF>
S:<ACK>
R:<STX>7R|1|^^^HBsAg|59.882||<CR><ETX>33<CR><LF>
S:<ACK>
R:<STX>0L|1|N<CR><ETX>03<CR><LF>
S:<ACK>
R:<EOT>
Table 2-6: Example - Compact mode disabled / Export only final result
R:<ENQ>
S:<ACK>
R:<STX>1H|\^&|||9163500014<CR>P|1||42670070||MeirÂnna|
|19740410|F<CR>O|1|||^^^HBsAg<CR>R|1|^^^HBsAg|0.059||<CR>P|2|
|43681136||Mueller^Fritz||19940428|M<CR>O|1|||^^^HBsAg<CR>R|1
|^^^HbsAg|59.882||<CR>………..
S:<ACK>
R:<EOT>
Table 2-7: Example - Compact mode enabled / Export only final result
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2 ASTM Interface
R:<ENQ>
S:<ACK>
R:<STX>1H|\^&|||9163500014<CR><ETX>56<CR><LF>
S:<ACK>R:<STX>2P|1||42670070||MeirÂnna||19740410
|F<CR><ETX>48<CR><LF>
S:<ACK>R:<STX>3O|1|||^^^HBsAg<CR><ETX>72<CR><LF>
S:<ACK>
R:<STX>4R|1|^^^HBsAgÔD|0.002|O.D.|<CR><ETX>C2<CR><LF>
S:<ACK>
R:<STX>5R|2|^^^HBsAg^Qual Result|Neg||<CR><ETX>9E<CR><LF>
S:<ACK>
R:<STX>6R|3|^^^HBsAg^Quant Result|0.060||<CR><ETX>F0<CR><LF>
S:<ACK>
R:<STX>7P|2||43681136||Mueller^Fritz||19940428
|M<CR><ETX>40<CR><LF>
S:<ACK>
R:<STX>0O|1|||^^^HBsAg<CR><ETX>6F<CR><LF>
S:<ACK>
R:<STX>1R|1|^^^HBsAgÔD|1.879|O.D.|<CR><ETX>D6<CR><LF>
S:<ACK>
R:<STX>2C|1|I|No Liquid|I<CR><ETX>80<CR><LF>
S:<ACK>
R:<STX>3C|2|I|Man ID|I<CR><ETX>06<CR><LF>
S:<ACK>
R:<STX>4R|2|^^^HBsAg^Qual Result|Pos||<CR><ETX>B3<CR><LF>
S:<ACK>
S:<ACK>
S:<ACK>
R:<STX>7R|3|^^^HBsAg^Quant Result|56.370||<CR><ETX>2C<CR><LF>
S:<ACK>
S:<ACK>
S:<ACK>
R:<STX>2L|1|N<CR><ETX>07<CR><LF>
S:<ACK>
R:<EOT>
Table 2-8: Example - Compact mode disabled / Export all calculated results /
System flags included
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2 ASTM Interface
2.5 Data Record Usage

Refer to ASTM 1394, particularly Section 6 through 13 (see 2.7 Referenced
Documents).
TM
Each record sent by the Immunomat will contain up to the last field used by the
TM
Immunomat , which may or may not be all fields possible for the record. An ‘O’ in
Required or Sent field indicates optional. The first <MaxLength> characters are
significant only. Any more characters transmitted for a specific field are ignored.
2.5.1 Message Header Record

Field ASTM Field Description Valid Max Required
No. Contents Length
1 Record Type ID Character identifying ‘H’ 1 Y
the record as a
message header
2 Delimiter Definition The delimiters 4 Y
Any received defined in
delimiter set is ASTMSetupDialog
accepted. are sent.
3 Message Control ID N
4 Access Password N
5 Sender Name / ID Instrument ID 20 O
selected in the
ASTMSetupDialog
6 Sender Street N
Address
7 Reserved Field N
8 Sender Telephone N
No.
9 Characteristics of N
Sender
10 Receiver ID
11 Comment N
12 Processing ID N
13 Version No. ‘1’ 1 N
14 Date and Time of Format is 14 N
Message YYYYMMDD
HHMMSS
Table 2-9: Message Header Record
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2 ASTM Interface
2.5.2 Patient Information Record

No. Contents Length
1 Record Type ID Character identifying ‘P’ 1 Y
the record as a
patient information
record
2 Sequence Number Y
3 Practice Assigned N
Patient ID
4 Laboratory Assigned Becomes our Y
Patient ID PatientID
5 Patient ID No. 3 N
6^1 Patient Name O
6^2 Patient First Name O
7 Mother's Maiden N
Name
8 Birthdate 8 O
9 Patient Sex 1 O
10 Patient Race - Ethnic N
Origin
11 Patient Address N
12 Reserved Field N
13 Patient Telephone N
Number
14 Attending Physician Becomes our N
ID SenderID
15 Special Field 1 N
16 Special Field 2 N
17 Patient Height N
18 Patient Weight N
19 Diagnosis N
20 Active Medications N
21 Diet N
22 Practice Field No. 1 N
23 Practice Field No. 2 N
24 Admission and N
Discharge Dates
25 Admission Status N
26 Location N
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2 ASTM Interface

No. Contents Length
27 Nature of Alternative N
Diagnostic Code and
Classifiers
28 Alternative N
Diagnostic Code and
Classification
29 Religion N
30 Marital Status N
31 Isolation Status N
32 Language N
33 Hospital Service N
34 Hospital Institution N
35 Dosage Category N
Table 2-10: Patient Information Record
2.5.3 Test Order Record

No. Contents Length
1 Record Type ID Character identifying ‘O’ 1 Y
the record as a test
order record
2 Sequence Number Y
3 Specimen ID N
4 Instrument N
Specimen ID
5^4 Universal Test ID Test Abbreviation Y
5^5 Dilution N
6 Priority N
7 Requested / Ordered N
Date and Time
8 Specimen Collection ‘YYYYMMDDHHMM 14 O
Date and Time SS’
9 Collection End Time N
10 Collection Volume N
11 Collector ID N
12 Action Code N
13 Danger Code N
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2 ASTM Interface

No. Contents Length
14 Relevant Clinical N
Information
15 Date/Time Specimen N
Received
16 Specimen Descriptor N
(Type)
17 Ordering Physician N
18 Physician’s N
Telephone Number
19 User Field No. 1 N
20 User Field No. 2 N
21 Laboratory Field No. N
1
22 Laboratory Field No. N
2
23 Date/Time Results N
Reported or Last
Modified
24 Instrument Charge to N
Computer System
25 Instrument Section N
ID
26 Report Types N
27 Reserved Field N
28 Location of Ward of N
Specimen Collection
29 Nosocomial Infection N
Flag
30 Specimen Service N
31 Specimen Institution N
Table 2-11: Test Order Record
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2 ASTM Interface
2.5.4 Result Record

Please note, that the result record can just be send once to the host computer.
Please note, that the data value in field no. 4 includes only the final calculated
result, depending on the assay programming.
Export File
Option
Figure 2-3: Automatic create exported result files
1. The Preferences dialog can be accessed from Utilities | Options menu.

2. Select the Preferences tab.
3. Enable or disable the entry Automatic create exported result files.
o Enable:
When closing the result display the results are exported to a file and/or
LIMS automatically.
o Disable:
When closing the result display a dialog asks the user if he will export
the results to a file and/or LIMS. Additional there is a menu entry Export
Results in the menu Utilities.
4. Press on the OK button.
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2 ASTM Interface

No. Contents Length
1 Record Type ID Character R 1 Y
identifying the
record as a
result record
2 Sequence Number Y
3 Test ID N
4 Measurement Value ASTM result Final Y
OR/AND Calculated records can be calculated
Value defined in the result,
Assay / Export depends on
dialog box value
5 Units Y
6 Reference Ranges Y
7 Result Abnormal N
Flags
8 Nature of N
Abnormality Testing
9 Result Status N
10 Date of Change in N
Instrument
Normative Values or
Units
11 Operator N
Identification
12 Date/Time Test N
Started
13 Date/Time Test N
Completed
14 Instrument ID N
Table 2-12: Result Record
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2 ASTM Interface
2.5.5 Comment Record

Comment Records are used either to describe reasons for rejected test orders or to
supply additional result information, e.g. result relevant flags.
No. Contents Length
1 Record Type ID Character C 1 Y
identifying the
record as a
result record
2 Sequence Number Y
3 Comment Source N
4 Comment Text Flag name Depends Y
5 Comment Type N
Table 2-13: Comment Record
2.5.6 Request Information Record

Not applicable.
2.5.7 Message Terminator Record

Field ASTM Field Description Valid Required Sent
No. Contents
1 Record Type ID Character identifying ‘L’ Y Y
the record as the last
record in the
message
2 Sequence Number Y Y
3 Termination Code N N
Table 2-14: Message Terminator Record
2.5.8 Scientific Record

A Scientific Record must not be sent
2.5.9 Manufacturer Information Record

A Manufacturer Information Record must not be sent.
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2 ASTM Interface
2.6 LIMS Query for Test Order Requests
2.6 LIMS Query for Test Order Requests

If the ASTM Options tab has the Query Host for Test Order Requests checkbox
enabled then whenever a patient sample rack is inserted a query request will be sent
to the LIMS for each patient sample.
One query will be sent for each patient sample. Each query has the following format
and is contained within a message header record (H) and message terminator record
(L):
o Q|1|xxx||ALL||||||||O<CR>
Where: xxx is the patient sample ID scanned from the barcode fixed to the
sample tube.
<CR> is the record terminator ASCII(13).
The LIMS should respond with the relevant patient identifying record (P) and 0 or
more test order records (O) contained within a message header record (H) and
message terminator record (L). If there are no test order requests for that patient then
the LIMS can either respond with just a header and terminator record, or can send the
patient identifying record with no test order records.
The query for the next patient sample will not be sent until a response has been
received to the previous query.
If no response is received to the query within the time out specified in the dialog box
then the software will send no further query requests for that sample rack.
Example:
H|\^&|||<CR>
Q|1|40095810||ALL||||||||O<CR>
L|1|N<CR>
Table 2-15: Example query for patient sample ID: 40095810
H|\^&|||<CR>
P|1|40095810<CR>
O|1|||^^Âssay1<CR>
O|2|||^^Âssay2<CR>
L|1|N<CR>
Table 2-16: Response indicating that "Assay1" and "Assay2" should be run for the
patient:
H|\^&|||<CR>
P|1|40095810<CR>
L|1|N<CR>
Or
H|\^&|||<CR>
L|1|N<CR>
Table 2-17: Response indicating that there are no remaining tests for the patient:
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2 ASTM Interface
2.7 Referenced Documents
2.7 Referenced Documents
ASTM Standards o E 1381 Standard Specification for Low-Level Protocol to Transfer Messages
Between Clinical Laboratory Instruments and Computer Systems (Annual
Book of ASTM Standards, Vol 14.01.)
o E 1394 Standard Specification for Transferring Information Between Clinical
Instruments and Computer Systems (Annual Book of ASTM Standards, Vol
14.01.)
TM
3 ASCII File Transfer
3.1 Introduction
3.1 Introduction
TM
The Immunomat has the possibility to receive worklist files and transmit result files
from and to a LIS. Both file formats (Import and Export) can be defined within the
TM
Immunomat software.
The import of worklist files can be performed manually by the user or automatically
with a polling sequence.
3.2 Hardware Configurations

TM
The communication between the Immunomat and the host system is established
using an Ethernet card.
TM
In case that the Immunomat computer should be connected to an other host
system, please install the necessary protocol or client and configure it according to the
specifications for this host.
For all type of servers take care of following restrictions:

The file names should no be longer than 20 characters
Do not use special characters in the file names except “-“ and “_”
Characters for file names allowed: Numbers from 0 to 9 and Letters from A to
Z (small and big capitals)
TM
3.3 Manual Import of a Worklist
3.3.1 Import a Worklist File

TM
1. Choose File | Open at the main menu of the Immunomat software and the
file open dialog will be shown.
Figure 3-1: Open import file
2. As file type "ASCII Patient Information (*.txt) must be selected.

3. Select the corresponding folder on your local drive or network.
4. Select the worklist file (e.g. Import.txt) from the folder.
5. Click on the Open button.
The file format of “Import.txt” is described in chapter 3.3.2 Examples of Import

files.
The following window will be displayed:
TM
Figure 3-2: ASCII Patient Information Import
This setup menu allows you to define the format of the files that you want to import.
6. Select the entry 'Has Header Row' if the file has, as it’s first record the
heading labels.
Please note, that the Header labels must consists of the same records as
shown in the 'Available Fields' list!
7. Select the entry 'Use Header Row to determine Mappings' or create the
'Select Fields' box, if the header from the file should not be used to determine
mappings. The 'Selected fields' must be created in the order they appear in
the file.
8. Select the separator character. As default ‘comma’ is defined.
9. Click on the OK button.
Once a ‘Patient Import’ setting has been created, it can be saved (save
settings…) for re-use (Open settings…) later.
Patient ID Alphanumeric strings accepted.

Patient Name No limits on patient name
Birthdate YYYYMMDD
Sex ASTM states M, F, or U but no actual restrictions
Test name Test name must correspond exactly to the assay protocol stored in
the ‘Assay Protocol Files’ sub-directory – default
C:\Phoenix\Assays.
Collection Date YYYYMMDDHHMMSS
Table 3-1: Available fields to import.
If all settings have been done the file import is confirmed with a message.
TM
This message just confirms that the file has been imported – this message
does not confirm the correct import of all the date fields.
TM
The imported information are transferred into the Immunomat Patient management.
TM
11. Chose Utilities | Patient Details…' at the main menu of the Immunomat
software.
Figure 3-3: Patient editor with the imported worklist
If you import an other worklist the existing information will not be overwritten.
New information will be added to the existing one.
3.3.2 Examples of Import files

Example 1 File:
Patient ID,Test name,Test name,Test name
AD001,CYTO-IgG,HSV 2 IgG,RUBE-IgG
AD002,CYTO-IgG,HSV 2 IgG,RUBE-IgG
BF056,CYTO-IgG,HSV 2 IgG,RUBE-IgG
RR008,CYTO-IgG,HSV 2 IgG,RUBE-IgG
RR015,CYTO-IgG,HSV 2 IgG,RUBBE-IgG
TM
File:
Meaning:
First Line: Header Row (Separator “,”)
Second Line: Data fields (Separator “,”)
Table 3-2: File includes Patient ID and Test names
Example 2 File:
Patient ID,Patient name,Test name,Test name,Test name,Test
name,Birthdate,Sex
AD001,Williams Mandy,CYTO-IgG,HSV 2 IgG,RUBE-IgG,,19710520,F
AD002,Graham Michael,CYTO-IgG,HSV 2 IgG,RUBE-IgG,TOXO-
IgG,19520815,M
BF056,Mulder Ken,CYTO-IgG,HSV 2 IgG,RUBE-IgG,TOXO-
IgG,19801208,M
RR008,Fox Judy,CYTO-IgG,HSV 2 IgG,,,19750416,F
RR015,Black Bill,CYTO-IgG,HSV 2 IgG,RUBE-IgG,,19860904,M
Meaning:
First Line: Header Row (Separator “,”)
Second Line: Data fields (Separator “,”)
Table 3-3: File includes Patient ID, Test names and Details
If a patient does not have all fields which are defined in the header (e.g.
Patient “RR008” has just two Test name), the data field must be empty but
separated via “,”.
This means:
Number separators Header Field = Number separators Data Field
The Patient Editor (see Figure 3-3: Patient editor with the imported worklist)
represents the example file 2.
1. To show patient details select a Patient ID.
2. Click on the Edit button.
Figure 3-4: Patient Details
TM
3.4 Automatic Import of a Worklist File
3.4 Automatic Import of a Worklist File
3.4.1 File Polling

TM
The Immunomat software allows the User to configure specific locations that the
software will poll looking for ASCII patient information files. When a valid file is found,
it is imported into the software, interpreted and the patient database updated with the
new patient details. The User determines the frequency the software polls the
specified directory.
3.4.2 Setup Polling

TM
1. Choose Utilities | Options at the main menu of the Immunomat software.
2. Select the File Polling tab.
Figure 3-5: File polling configuration
3. To specify the ASCII file format click on the File Options button and select the
appropriate labels.
File Options is the same dialog when used manually from the File | Open
menu item (see 3.3.1 Import a Worklist File).
The system time of the server and the system time of the ImmunomatTM
computer must be synchronized!
If the system time of the server is behind the system time of the
ImmunomatTM computer and they deviate more than the defined polling time
the worklist files will never be imported !
TM
4 Export of files
4.1 Directory for Export Files
4 Export of files
4.1 Directory for Export Files

TM
The Immunomat software allows the ASCII export of data.
The destination where the Export Files shall be transferred can be defined in the
options.
TM
1. Choose Utilities | Options at the main menu of the Immunomat software.
2. Select the Directories tab.
Figure 4-1: Present the directories
3. Select the file-type Export Files.

4. Click on the Browse button.
5. Select the target folder (default setting is C:\Phoenix\Export).
7. Select a file or write a name (e.g. xxx) in the File name field.
Do not change the target folder for the result files.
TM
4 Export of files
4.2 Assay Definition for Export
As soon as a result is available the software generates an ASCII file (*.txt) which is
than automatically transferred to the defined target folder.
If a file should be exported and the target folder is not available, the following
message appears:
Figure 4-2: Error message
As soon as the communication is build up again, open the Result File in

TM
Immunomat Software (Subdirectory Result Files) once again and the Export File
will be generated and transferred automatically.

Within every assay definition you will find in the sub-category “Read” a report section,
which can be customized to the customer needs.
1. To set up or open the settings, click on the Read Step.
2. Double click on Report Settings.
Figure 4-3: Report Settings
TM
4 Export of files
Please note, that the default setting only includes the assay header and
reader results. The export file format can be individually customized for each
test according to the customer needs.
3. Select the Export tab.
Figure 4-4: Export settings
4. Click on Settings... button.
Figure 4-5: Text file settings
The format can be table or matrix, normally a table format is used for ASCII export.
TM
4 Export of files
Define the settings according to the customer needs from the available header and
data fields windows.
4.2.1 Available Header and Data Fields

Fields: Meaning:
Assay Header Date and time, OVER limit, operator and wavelengths
Kinetic readings Raw data from each read
Validation criteria QC evaluation
Qualitative Qualitative QC, qualitative equations and notes
Quantitative Quantitative notes
Patient ID Patient ID
Assay Assay name
Well Location e.g. A1
Layout Label e.g. T1
Flag Clot detection, No liquid detected , Read error, MP
Reader value Reader value for that replicate
Reader mean Averaged reader value across replicates
Reader SD Standard Deviation of replicates
Reader CV %co-efficient of variation of replicates
Reader SE Standard Error of replicates
Reader units Reader units
Qual. Value As above, but for qualitative results
Qual. Mean As above, but for qualitative results
Quant. 1 value As above, but for 1st curve fit (quantitative)
Quant. 1 mean As above, but for 1st curve fit (quantitative)
Quant. 1 SD As above, but for 1st curve fit (quantitative)
Quant. 1 CV As above, but for 1st curve fit (quantitative)
Quant. 1 SE As above, but for 1st curve fit (quantitative)
Quant. 1 units As above, but for 1st curve fit (quantitative)
Spread. Value As above, but for spreadsheet results
Spread. Mean As above, but for spreadsheet results
Spread. SD As above, but for spreadsheet results
Spread. CV As above, but for spreadsheet results
Spread. SE As above, but for spreadsheet results
Spred. Units As above, but for spreadsheet results
Quant. 2 value As above, but for 2nd curve fit (quantitative)
Quant. 2 mean As above, but for 2nd curve fit (quantitative)
TM
4 Export of files
4.3 Examples of Export Files
Fields: Meaning:
Quant. 2 SD As above, but for 2nd curve fit (quantitative)
Quant. 2 CV As above, but for 2nd curve fit (quantitative)
Quant. 2 SE As above, but for 2nd curve fit (quantitative)
Quant. 2 units As above, but for 2nd curve fit (quantitative)
Table 4-1: Meaning of header and data fields
Example 1 File: Meaning:

[HSV 2 IgG]
No header
information
[Results]
Patient ID,Assay,Reader value,Quant.1 value,Qual. Value Data field
"","HSV 2 IgG","0.009","1.000","NC1" header
"","HSV 2 IgG","0.011","1.000","NC2"
"","HSV 2 IgG","0.093","1.000","NC3"
separated via
"","HSV 2 IgG","1.455","48.500","PC1" “,”
"","HSV 2 IgG","1.465","48.833","PC2"
"AD001","HSV 2 IgG","0.004","0.133","neg"
"AD002","HSV 2 IgG","0.075","2.500","equ"
"BF056","HSV 2 IgG","0.011","0.366","neg"
"RR008","HSV 2IgG","0.002","0.066","neg"
"RR015","HSV 2 IgG","0.987","32.900","pos"
Table 4-2: Export Files without Header Fields defined
Example 2 File: Meaning:

[HSV 2 IgG]
Time:;11:15:00 Assay Header
Date:;27/09/00 Field
OVER limit:;3.000
Operator:;User
Wavelengths:;450nm/620nm
-0.01<=NCi<=0.50;-0.01<=0.010<=0.50
;-0.01<=0.009<=0.50 Validation
;-0.01<=0.011<=0.50 Criteria
;-0.01<=0.093<=0.50;Removed Header Field
Valid(NC)>=2;2>=2
PCi>=0.550;1.460>=0.55
;1.455>=0.55
;1.465>=0.55
valid(PC)=2;2=2
If 'Sample<(NC+0.05)*0.9' Then Result:='neg' Qualitative
If 'Sample>=(NC+0.05)*1.1' Then Result:='pos'
Header Field
Default result := equ
cut off;(NC + 0.055);0.060
TM
4 Export of files
File: Meaning:
[Results]
Patient ID,Assay,Reader value,Quant.1 value,Qual. Value Data field
"","HSV 2 IgG","0.009","1.000","NC1" header
"","HSV 2 IgG","0.011","1.000","NC2"
"","HSV 2 IgG","0.093","1.000","NC3"
separated via
"","HSV 2 IgG","1.455","48.500","PC1" “,”
"","HSV 2 IgG","1.465","48.833","PC2"
"AD001","HSV 2 IgG","0.004","0.133","neg"
"AD002","HSV 2 IgG","0.075","2.500","equ"
"BF056","HSV 2 IgG","0.011","0.366","neg"
"RR008","HSV 2IgG","0.002","0.066","neg"
"RR015","HSV 2 IgG","0.987","32.900","pos"
Table 4-3: Export Files with Header Fields defined
TM
Manufacturer
Institut Virion\Serion GmbH Friedrich-Bergius-Ring 19, 97076 Würzburg, Germany

Phone +49 931 3045 0 Fax +49 931 3045 100 Mail [email protected] Web www.virion-serion.de

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1.4 ASTM Link Overview

Table 2-1: Customizing

Figure 2-1: ASTM configuration

2.2 Low-Level Protocol

2.2.1 Physical Layer

Figure 2-2: RS232 Connection to Host

2.2.2 Data Link Layer

2.3 Logical Structure of the Message Level

Table 2-2: Logical Structure of the Message Level Protocol

2.4 Incoming and Outgoing Transmission

2.4.1 Host to ImmunomatTM

Table 2-3: Structure of ASTM 1394 and ASTM 1381

Table 2-4: Example

2.4.2 Test Results

2.4.3 ImmunomatTM to Host

Table 2-5: Structure of ASTM 1394 and ASTM 1381

2.5 Data Record Usage

2.5.1 Message Header Record

Table 2-9: Message Header Record

2.5.2 Patient Information Record

Field ASTM Field Description Valid Max Required

Table 2-10: Patient Information Record

2.5.3 Test Order Record

Field ASTM Field Description Valid Max Required

Table 2-11: Test Order Record

2.5.4 Result Record

Figure 2-3: Automatic create exported result files

1. The Preferences dialog can be accessed from Utilities | Options menu.

Field ASTM Field Description Valid Max Required

Table 2-12: Result Record

2.5.5 Comment Record

Table 2-13: Comment Record

2.5.6 Request Information Record

2.5.7 Message Terminator Record

Table 2-14: Message Terminator Record

2.5.8 Scientific Record

2.5.9 Manufacturer Information Record

2.6 LIMS Query for Test Order Requests

Table 2-15: Example query for patient sample ID: 40095810

2.7 Referenced Documents

3 ASCII File Transfer

3.2 Hardware Configurations

For all type of servers take care of following restrictions:

3.3 Manual Import of a Worklist

3.3.1 Import a Worklist File

Figure 3-1: Open import file

2. As file type "ASCII Patient Information (*.txt) must be selected.

The file format of “Import.txt” is described in chapter 3.3.2 Examples of Import

The following window will be displayed:

Figure 3-2: ASCII Patient Information Import

Patient ID Alphanumeric strings accepted.

Table 3-1: Available fields to import.

10. Click on the OK button.

Figure 3-3: Patient editor with the imported worklist

3.3.2 Examples of Import files

Table 3-2: File includes Patient ID and Test names

Figure 3-4: Patient Details