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for
Automatic Chemiluminescence
Immunoassay Analyzer CLIA1200
1
1. Standard of Hardware Interface in
External System
1.1. Overview
This document details the specifications for the CLIA 1200 host interface. This interface
regulates data transmissions between the core of the system and the host computer.
CLIA 1200 performs host communication with external system (usually refers to LIS) using
RS232 (serial) as system interface.
2
1.3. Connection Diagram:
TxDPin3 TxDPin3
RxDPin2 RxDPin2
RTSPin7 RTSPin7
CTSPin8 CTSPin8
GNDPin5 GNDPin5
2. ASTM Protocol
2.1. Background
ASTM (American Society of Testing and Material) has a plan for communications between
automatic analyzers and host computers for standards E1381_91 (Specification for Low_ Level
Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer
Systems) and E1394_91 (Standard Specifications for Transferring Information Between Clinical
Instruments and Computer Systems). The basic specifications of the standards are regulated
on X12 of ANSI.
The host communication interface installed in the CLIA 1200 system meets the
standards of ASTM.
The communication process between the system and the host is divided into three layers as
shown below. This specification explains the processing and operation methods for the
application layer.
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ASTM E1381_91 Lower Level Protocol
Specification for Low Level Protocol to Transfer Messages Between Clinical Laboratory
Instruments and Computer Systems
ASTM lower layer receives messages for a transmission request from the upper layer.
These messages are then split into frames and sent to a communication medium to be
transmitted to other parties. ASTM lower layer also constructs frames received from a
communication medium to recreate messages to be transferred to the ASTM upper
layer as reception messages. Configuration and communication procedures for
transmission and reception of frames are explained in the following chapters.
ASTM Bottom Layer Communication Protocol Table:
Item Method Introduction
4
<ETB>C1 C2 <ETX> is a control character (0x03).
Maximum Length 247 characters For one frame, maximum of 240 characters for text, 7
of the Frame characters for frame control characters.
Messages equal to or less than 240 characters are
transmitted as one final frame. Messages greater than
240 characters are split into frames that have
character lengths that fall within the 240_character
limit. The only or final remaining frame becomes the
last frame and is indicated by <ETX>. All others are
intermediate (middle) frames and are indicated by
<ETB>.
ASTM Lower Layer Communication Methods
5
2.4. ASTM Syntax
2.4.1. Definition
This section deals with message coding rules as well as special characters, such as
delimiters, used to develop messages provided by records and fields.
The ASCII CR character (HEX 0D) is always used to indicate the end of a record.
A Field delimiter is a character used to separate fields that are next to each other in a
record. This is also a delimiter for the first Record ID (character that appears in the
beginning of a record) and the next field. According to the 2nd character that appears
in the Message Header Record (record that appears in the front of a message), a Field
delimiter can be defined with an optional character through the Message Header
Record; however, it is recommended that a vertical bar '|' be used.
6
2.4.2.3. Repeat Delimiter = Backlash '\'
When a field is constructed by the same data repeated several times, it is referred to as
a Repeated Field. The delimiter between the repeated items for the Repeated Field is
called the Repeat delimiter. Repeat delimiters can be defined with an optional
character through the Message Header Record; however, it is recommended that a
backslash '\' be used
An Escape character is provided to indicate a delimiter for the fields that include
general text. When this character occurs in a relevant field, the next character holds a
special meaning (discussed below). An Escape character can be defined with an
optional character through the Message Header Record; however, it is recommended
that an ampersand '&' be used.
Character
The following Escape sequence (starting with & and ending with &) is defined. When
this sequence is detected in a field, it is changed to a corresponding character and
deleted. Escape sequences other than these are skipped and treated as NULL value.
&F& Indicates Field delimiter
&S& Indicates Component delimiter
&R& Indicates Repeat delimiter
&E& Indicates Escape
To establish which system sends and which system receives information and to assure
the actions of sender and receiver are well coordinated, there are three distinct phases
in transferring information:
Establishment Phase
7
Transfer Phase
Termination Phase
Introduction:
The character in [] is control character which is invisible and in general text tool
exhibits gibberish. While the character outside [] is visible.
For a complete message, if the message length is less than 240 characters, there is
only one frame, end frame; if larger than 240 characters, it contains at least an
intermediate frame and an end frame data;
8
The length of control character (means the part except frame data text) is 7
characters.
[STX] The ASCII code 2, indicating the beginning of a frame transmission.
The ASCII code 3(0x03), indicating the end of the text block of an end
[ETX]
frame.
Transmission:
[STX] 1Test [ETX] D4 [CR] [LF]
9
2.4.5. Communication Text Content
The following table shows the Standard Record types and levels (see ASTM E
1394_91 Section 5, 'Information Requirements in Clinical Testing')
Level Record Name Identification
3 Result Record R
All messages are shown in the following table. The message content is described in detail in
the following section.
Communication Text Communication Direction
Messages transmitted by the analyzer (messages received by the host) are indicated
in the table below.
The identifier is set in the Comment or Special Instruction Field in the Message Header
Record with the reason for the messages.
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Comments or
Message Syntax/Records Special Reason
Instructions
n=0~160
Messages transmitted by the host are shown in the table below (messages received by
the analyzer).
Comment or
Messages Syntax/Records Special Reasons
Instructions
11
2.4.6. Record Description
2 Reference Position of the field. Order in which the relevant fields appear in a record.
12
5 Comment Contains field contents and any relevant field comments.
(Data Content) Note: A field with the message 'Field does not contain data' in the
column means that even though it is provided by ASTM, it may be
ignored when received.
This record occurs in the front of a message and indicates the goal of the message,
such as origination and destination.
H|\^&||| CLIA 1200PLUS^1||||| host| RSUPL^REAL| P|1
Notice: * Indicates a field or field component required in ID and Sample No. modes.
Max
Field Name Format Comments (Data Content)
Length
Message Control ID _
Access Password _
Reserved Field _
Sender Telephone _
Number
Characteristics of _
Sender
Receiver ID* ST 30 Name of the machine receiving this message.
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CLIA 1200 system reception process: CLIA 1200
Instrument Name.
Comment or Special CM 11 A comment regarding the message is entered here.
Instructions
CLIA 1200 system transmission process
To indicate classification of the transmitted message
from the analyzer, one of the following is transmitted.
TSREQ^REAL RSUPL^REAL RSUPL^BATCH
14
2.4.6.3. Message Termination Record
This record occurs at the end of a message to indicate the end of a message.
L|1| N
Max
Field Name Format Comments (Data Content)
Length
N: Normal Termination
E: System error
This record is used to transfer patient information to the analyzer (within test selection
message) or to the host (within result message).
P|1|||||||M||||||29^Y
Max
Field Name Format Comments (Data Content)
Length
15
Laboratory Assigned _
Patient ID
Patient ID No.3 _
Patient Name _
Patient Race-Ethnic _
Origin
Patient Address _
Reserved Field _
Patient Telephone _
Number
Attending Physician ID _
Element Description
Age Age of the Patient from whom the
sample was collected. Range 1-200
Age Unit Specify 'Y', 'M' or 'D'. Indicates unit of
the age. 'Y' is the year, 'M' is the
month, and 'D' is the day.
Special Field 2 _
Patient's Known or _
Suspected Diagnosis
Patient Active _
Medications
Patient's Diet _
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Practice Field No.1 _
Admission and _
Discharge Dates
Admission Status _
Location _
Nature of Alternative _
Diagnostic Code and
Classifiers
Alternative Diagnostic _
Code and Classifiers
Patient Religion _
Marital Status _
Isolation Status _
Language _
Hospital Service _
Hospital Institution _
Dosage Category _
This record holds information regarding analysis request and sample information to the
analyzer (within test selection message) and to the host (within result message).
O|1|000140940004|3^1^4^^S1^SC|^^^23^1\^^^24^1\^^^25^1\^^^26^1\^^^27^1|R||20141
011114506||||N||||1|||||||20141011113029|||F
Forma Max
Field Name Comments (Data Content)
t Length
17
2, etc., for each occurrence of this record.
*
Specimen ID ST 22 Identification procedure for samples by the analyzer.
Sample:
Sample ID Barcode attached to the test
tube. The barcode label is read
by the system's barcode
reader. The total valid
character number is 22
Sample Seq. CLIA 1200 sets the start as
No. well as end location
according to it and
performs numbering
according to initial
sequence number.
Control:
Format: <Control No.>^<Control
Name>^<Batch No.>
(example: 1^HBS^011415011)
Format:
Sample No 5 NM
Tray No 1 NM
Position No 2 NM
Sample 2 ST
Type
Container 2 ST
Type
Element Description
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sample' is used.
ex. Control No. = 3, Sequence
No. = 2 is written as 3002.
Tray No ID of the Sample Tray with 50
samples, Values 0 ~ 9.
Position No Values 1 ~ 5. Counting from the
tray's forward direction, the
position of the first sample is 1
and the last sample is 50.
Sample S1: Blood Serum / Plasma
Type S2: Urine
SO: Others
QC: Control
(example: ^^^21^1\^^^22^1\^^^23^1)
Application 3 NM
Code
Dilution 3 ST
Element Description
19
using the standard analysis
parameters.
Requested/Ordered _
Date and Time
Specimen Collection TS 14 Date and time specimens were collected is
Date and Time designated by YYYYMMDDHHMMSS.
Collection End Time _
Collection Volume _
Collector ID _
Relevant Clinical _
Information
Date/Time Specimen _
Received
Specimen Descriptor* NM 1 This field indicates the specimen type and
the details are below:
Field Description
Value
1 Serum/Plasma
20
2 Urine
5 others
Ordering Physician _
Physician's Telephone _
Number
User Field No. 1 _
Date/Time Results TS 14 Indicates the date and time the result was obtained.
Reported or Last This field is not specified by a host.
Modified
Instrument Charge to _
Computer System
Instrument Specimen ID _
Location or Ward of _
Specimen Collection
Nosocomial Infection _
Flag
Specimen Service _
Specimen Institution _
Record to transfer comments regarding the patient's demographic data. This record is
transmitted by the host (within test selection message) and the analyzer (within result
message).
C|1| I|0| I
21
Max
Field Name Format Comments (Data Content)
Length
Max
Field Name Format Comments (Data Content)
Length
Format:
^^^<Application Code>/<Dilution>/<Pre-Dil.>
Max
Element Format
Length
22
Application
3 NM
Code
Dilution 3 ST
Pre-Dilution 11 ST
Element Description
Example:
1.117
>1000.000
<2.000
Example:
IU/mL
mIU/mL
S/CO
Reference Ranges _
23
L Lower value than
normal
A Abnormal
N Normal
_ Unused
Nature of Abnormality _
Testing
Result Status ST 1 Test times of analysis result
Instrument Identification _
Record to request information from the other device. It is sent by the analyzer (within test
selection request message) and the host (within result request message)
Q|1|^^000140940004^1^0^1^^S1^R|| ALL|||||||| O
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record is the layer that follows the Test Request
Record, it resets to '1' each time a new Test Request
Record is presented, and then it is numbered
consecutively; 1, 2, 3, 4, etc.
Starting Range ID CM 39 Format:
Number*
^^<Specimen ID>^<Sample No.>^<Tray
No.>^<Position No.>^^<Sample
Type>^<Sample Priority>
Specimen ID 22 ST
Sample No. 5 NM
Tray No. 1 NM
Position No. 2 NM
Sample Type 2 ST
Sample Priority 1 ST
Element Description
25
50 samples, Values 0 ~ 9.
Position Values 1 ~ 5. Counting
No. from the tray's forward
direction, the position of
the first sample is 1 and
the last sample is 50.
Sample S1: Blood Serum / Plasma
Type S2: Urine
SO: Others
Sample R: Routine Sample
Priority S : Stat Sample
Starting Range ID _
Number
Universal Test ID 'ALL'
In this section, some examples of communication on ASTM Upper Layer are shown.
Space Character (ASCII CODE 0x20) in any text is shown as '·'.
This example text contains some non-realistic cases for standard clinical immunity
analysis to show variable examples of communication.
In this section, the analyzer is shown as 'CLIA 1200', External system is shown as
'HOST'. The following words are used:
'S.No' means Sample Number.
'TS' means Test Selection.
26
CLIA 1200 #5'
HOST #6'
CLIA 1200 #2'1H|\^&|||CLIA
1200PLUS^1|||||host|TSREQ^REAL|P|1#13'Q|1|^^000140940004^3^1^
3^^S1^R||ALL||||||||O#13'L|1|N#13'#3'C5#13'#10'
HOST #6'
CLIA 1200 #4'
HOST #5'
CLIA 1200 #6'
HOST #2'1H|\^&|||HOST|||||CLIA 1200PLUS^1|TSDWN^REPLY|P|1#13'P|1|||||||U||||||^#13'O|1|0
00140940004|3^1^3^^S1^SC|^^^23^1\^^^24^1\^^^25^1\^^^26^1\^^^27^1|R||2014040
9105117||||A||||1||||||||||O|#13'C|1|I|^^^^|G#13'L|1|N#13'#3'8E#13'#10'
CLIA 1200 #6'
HOST #4'
27
CLIA 1200 #2'1H|\^&|||CLIA
1200PLUS^1|||||host|RSUPL^REAL|P|1#13'P|1|||||||U||||||#13'O|1||2^0^3
2^^QC^SC|^^^7^1|R||20141104113032||||Q||||1|||||||20140403145857|||F#13'C|1|I|^^^^
|G#13'R|1|^^^7/1/not|41.043|IU/mL||||F|||||#13'C|1|I|0|I#13'L|1|N#13'#3'D9#13'#10'
HOST #6'
CLIA 1200 #4'
3. Appendix
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21 f_PSA
22 t_PSA
23 HbsAg
24 anti_HBS
25 HBeAg
26 anti_HBe
27 anti_HBc
28 anti_HBcIgM
29 HIVAg/Ab
30 anti_TP
31 anti_HCV
32 HCG
33 HBsAg_Quant
34 PreS1Ag
35 PreS2Ag
36 TOXOIgG
37 TOXOIgG
38 RVIgG
39 RVIgM
40 CMVIgG
41 CMVIgG
42 HSV1/2IgG
43 HSV1/2IgM
44 HSV_2IgG
29