Host Interface Manual

for
Automatic Chemiluminescence
Immunoassay Analyzer CLIA1200

File version V1.1

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.

Questions concerning this document should be referred to Technical Support.

CLIA 1200 performs host communication with external system (usually refers to LIS) using
RS232 (serial) as system interface.

1.2. Pin Description

Number Abbreviation Pin Name Pin Description Transmission

1 DCD DataCarrierDetect Data carrier detect Unused
2 RXD ReceiveData Serial Data Input CLIA 1200←HostSystem

3 TXD TransmittedData Serial Data Output CLIA 1200→HostSystem

4 DTR DataTerminalReady Data Terminal Ready Unused

5 GND SystemGround Public Grounding CLIA 1200―HostSystem
Location
6 DSR DataSetReady Data Transmission Unused
Ready
7 RTS RequestToSend Request To Send CLIA 1200→HostSystem

8 CTS ClearToSend Clear To Send CLIA 1200←HostSystem

9 RI RingIndicator Ring Indicator Unused

2
 1.3. Connection Diagram:

CLIA 1200 HostSystem

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.

2.2. Communication Processing Layer

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.

3
ASTM E1381_91 Lower Level Protocol

Specification for Low Level Protocol to Transfer Messages Between Clinical Laboratory
Instruments and Computer Systems

ASTME1394_91 High Layer Protocol

Standard Specification for Transferring Information Between Clinical Instruments and

Computer Systems.

2.3. ASTM Lower Layer

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

Frame For Intermediate Frame  Control Character (characters enclosed in

Configurations <>):
<STX>FN text
<STX> is a control character (0x02) (0x
<ETB>C1 C2 represents hexadecimal and the subsequent
is at the same).
<CR><LF>
<ETB> is a control character (0x17).
For End Frame
<CR> is a control character (0x0D).
<STX>FN text
<LF> is a control character (0x0A).

4
 <ETB>C1 C2 <ETX> is a control character (0x03).

<CR><LF>  FN: FN is a single ASCII number. FN indicates

the sequence number for a frame (the frame
number modulus 8). Frames of a single
transmission phase are consecutively numbered
beginning with 1, so FN runs from 1 to 7, then
continues with 0, 1, and so on.
 Text: the data content of a frame (maximum 240
characters). Records are sub-divided into
intermediate (middle) frames with 240 or fewer
characters. Text is part of a split message.
 C1 and C2: When 1 byte resulting from adding
each byte, FN to <ETB> for the middle frame
and FN to <EXT> for the last frame, is expressed
in hexadecimal, the upper character (161) is C1
and the lower character (160) is C2. Characters
used are '0' to '9' or 'A' to 'F'.
Frame Character Other Characters: <SOH> is a control character (0x01).
Configuration of
<SOH><STX><ETX> <EOT> is a control character (0x04).
Text

<EOT><ENQ><ACK> <ENQ> is a control character (0x05).

<DLE><NAK><SYN> <ACK> is a control character (0x06).

<CR><LF> <DLE> is a control character (0x10).

<DC1><DC2><DC3> <NAK> is a control character (0x15).

DC4. <SYN> is a control character (0x16).

<DC1>~<DC4> are control characters

(0x11~0x14).

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

The structure of the sentences to be transferred, according to ASTM Communication

Regulation, is explained in this section. Between the analyzer and the host, various
data such as Test Requests and Results are transferred back and forth. All of these
data conform to this syntax.

2.4.1. Definition

Message A message is constructed with an arrangement of several records (refer

to the next item). It is the smallest unit of information transferred
between a host and an analyzer. Messages begin with a 'Message
Header Record' that indicates the beginning of a message and end with
a 'Message Termination Record' that indicates the end of a message.

Record A record is constructed from several fields and expresses a single

purpose (such as to specify result reports or test requests). A record
may be repeated or used singularly in a message. Code that indicates
the purpose of a record is noted in the first character of that record.

Field A field is the ASTM's smallest element to construct information.

Attributes for a field (name, format, and meanings) are defined in units
in a record.

2.4.2. Coding Rules for the Message

This section deals with message coding rules as well as special characters, such as
delimiters, used to develop messages provided by records and fields.

2.4.2.1. End Character of Record

The ASCII CR character (HEX 0D) is always used to indicate the end of a record.

2.4.2.2. Field Delimiter = Vertical Bar '|'

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

2.4.2.4. Component Delimiter = Caret '^'

When a field is constructed by several elements, it is referred to as a Component Field.

The delimiter between these elements is the Component delimiter. The Component
delimiter can be defined with an optional character through the Message Header
Record; however, it is recommended that a caret '^' be used.

2.4.2.5. Escape Character = Ampersand '&'

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.

2.4.2.6. Expression of Special Characters with Escape

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

2.4.3. Message Transmission Phases

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

Message Transmission Phases

Sender Sender means CLIA 1200.

Receiver Receiver means host system (LIS).
ENQ Enquiry (ENQ) contains only one character 0x05.
ACK Acknowledgement (ACK) contains only one character 0x06.
intermediate frame The number of intermediate frame will be 0 or several in an integral
message transmission phase.
end frame End frame
EOT End of transmission (EOT) contains only one character 0x04, and the
message does not need ACK response from LIS. EOT is used to show
that a full transmission of message has been completed.
Within the transfer phase, all records of the corresponding message are grouped into
longer frames to increase speed. The records are separated through a [CR] character.
Therefore, to obtain pure ASTM records again, the receiver must concatenate all the
frames and wait for a [EOT] character. Then, finally, he can process the frame and split
it into different records using the [CR] as separator.

2.4.4. Check and Calculation of Message Frame

The Intermediate Frame

[STX] FN Text first char. ...... Text last char. [ETB] CH CL [CR] [LF]
The End Frame
[STX] FN Text first char. ...... Text last char. [ETX] CH CL [CR] [LF]

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 frame number modulus 8. Frames of a single Transmission Phase

FN are consecutively numbered beginning with 1. So FN runs from 1 to 7,
continues with 0, 1, and so on. Use ASCII codes for the digits '0' (0x30)
to '7' (0x37).
The data content of a frame (max. 240 characters).
Text Records are sub-divided into intermediate frames with 240 characters.
Maximum is indicated by [ETB]. The only or last remaining frame is
indicated by [ETX]. Different records must be sent in different frames.
The ASCII code 23 (0x17), indicating the end of the text block of an
[ETB]
intermediate frame.

The ASCII code 3(0x03), indicating the end of the text block of an end
[ETX]
frame.

Represents the high nibble (= most significant 4 bit) respectively, the

low nibble (=least significant 4 bit) of the 8-bit checksum. CH and CL are
CH, CL
represented as two digits of hex numbers. The checksum is the
modulus 8 of the sum of ASCII values of the frame characters starting
with and including 'FN' and completing with [ETX] respectively [ETB].
CR means carriage return, ASCII code 13 (0x0D), while LF means line feed,
CR, LF
ASCII code 10 (0x0A), used to identify the end location of each frame.

Example For Checksum Calculation

[STX] 1Test [ETX]

Character Value Sum (HEX)

[STX] 0x02 0x00 [STX] is not included in
'1' 0x31 0x31
'T' 0x54 0x85
'e' 0x65 0xEA
's' 0x73 0x015D
'T' 0x74 0x01D1
[ETX] 0x03 0x01D4
<0x01D4>%(Mode)<0x0100>=<0xD4>

Transmission:
[STX] 1Test [ETX] D4 [CR] [LF]

9
 2.4.5. Communication Text Content

2.4.5.1. Record Levels

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

0 Message Header Record H

1 Patient Information Record P

2 Test Order Record O

3 Result Record R

1...3 Comment Record C

1...3 Manufacturer Information Record M

0 Message Termination Record L

1 Request Information Record Q

2.4.5.2. Message Involved in Transmission

All messages are shown in the following table. The message content is described in detail in
the following section.
Communication Text Communication Direction

Test Selection Inquiry CLIA 1200→Host System

Test Selection Information Host System→ CLIA 1200

Patient Sample Analytical Data CLIA 1200→Host System

Control Sample Analytical Data CLIA 1200→Host System

2.4.5.3. Message Transmitted by the Analyzer

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.

10
 Comments or
Message Syntax/Records Special Reason
Instructions

Inquiry for the H

Inquiry is made for the requested
Requested Tests
Q TSREQ^REAL test just before loading the sample
(Test Selection tube (passing through the ID reader
Inquiry)
L or the sample seq. no.).

P Reports on the result at the point

RSUPL^REAL when the results for the (control)
Report Result O
sample have been accumulated.
(Patient Sample C
Analytical Data)
{R
(Control Sample
Analytical Data) C}n Transmits results of the selected
RSUPL^BATCH (control) sample(s) by instruction at
L
the analyzer.

n=0~160

2.4.5.4. Messages Transmitted by the Host

Messages transmitted by the host are shown in the table below (messages received by
the analyzer).
Comment or
Messages Syntax/Records Special Reasons
Instructions

Order for Test O TSDWN^REPLY Orders test request for a sample as

Request answer to a Test Selection Inquiry
C

11
 2.4.6. Record Description

2.4.6.1. Field Attribute

Types of attributes held by a field are explained below:

Number Attribute Description

1 Field Name Name of the relevant field.

2 Reference Position of the field. Order in which the relevant fields appear in a record.

3 Format The format for a field is one of the following:

 ST: String: A character string

 TX: Text: A group of character strings that can be

printed at the terminal. It is an optional
character string; however, a special escape
sequence is defined for a display at the
terminal.
 NM: Numeric: A numeric value. Positive (+) or negative (_)
is indicated before the numeric value. If it is
not indicated, it is treated as positive (+).
If a decimal point is not included, the
numeric value is treated as an integer.
There are no restrictions for placing '0' in
the front and for '0s' placed at the end of
numbers with decimal points.
 DT: Date: Always use the 4_digit Christian year. The
format is YYYYMMDD (YYYY is the 4_digit
Christian year, MM is the month, DD is the
day). For example, September 5, 2014 is
indicated 20140905.
 TM: Time: Military time.
The format is HHMMSS (HH is the hour,
MM is the minute, and SS is the second).
 TS: Time Stamp: A combination of DT and TM.
The format is: YYYYMMDDHHMMSS.

 CM: Combination: A field in which multiple data are combined

by a component delimiter (such as ^,/).
4 Maximum The maximum value of the number of valid characters for the relevant field
Length excluding escape delimiters.

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.

2.4.6.2. Message Header Record

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.

_ Indicates that the field doesn't involve data.

Max
Field Name Format Comments (Data Content)
Length

Record Type ID (H) * ST 1 Use 'H'.

Delimiter Definition* ST 4 Defines Field delimiter, Repeat delimiter, Component

delimiter, and four (4) Escape characters.
The first character defines the Field delimiter and also
corresponds to the Field delimiter of the Record Type
ID.
Four characters for this are: \ ^ &|

Message Control ID _

Access Password _

Sender Name or ID* CM 36 Name of the machine transmitting this message.

When transmitting from the analyzer, the registered
name of the CLIA 1200 Instrument Name is
transmitted (The default of instrument name is "CLIA
1200PLUS^1").
When transmitting from the host, the name is "host".
Sender Street Address _

Reserved Field _

Sender Telephone _
Number
Characteristics of _
Sender
Receiver ID* ST 30 Name of the machine receiving this message.

CLIA 1200 system transmission process: "host".

13
 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

The first component element indicates the purpose

for the message.
TSREQ: Test request inquiry
RSUPL: Result report

The second component element indicates

the case of message.

REAL: Message automatically generated by the

analyzer

BATCH: Message generated with an instruction by

an operator from the working terminal.
REPLY: Response message for inquiry from a host.

CLIA 1200 system reception process

To indicate classification of the transmitted message

from the host, one of the following is transmitted.
TSDWN^REPLY
The first component element indicates the purpose
for the message.
TSDWN: Registration of test request

The second component element indicates the cause

of the message.
REPLY: Response message for the inquiry from the
analyzer.
Processing ID ST 1 Indicates the processing method for the messages.
Currently 'P' is always used.

Version No. NM 1 Enter version number of the communication program.

Currently '1' is always used.

Date and Time of _

Message

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

Record Type ID (L)* ST 1 Use 'L'.

Sequence Number NM 1 Always '1'.

Termination Code ST 1 Input the value shown below.

N: Normal Termination

T: Forced termination of the transmitting side

R: Forced termination of the receiving side

E: System error

Q: Request error for the last reception (request is

rejected)

I: No information that corresponds to the inquiry in

the last reception

F: The last request was processed

2.4.6.4. Patient Information Record

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

Record Type ID (P)* ST 1 Use 'P'.

Sequence Number* NM 6 Sequence number of the Patient Information Record

in the message. It begins with '1'.
Practice Assigned _
Patient ID

15
Laboratory Assigned _
Patient ID

Patient ID No.3 _

Patient Name _

Mother's Maiden Name _

Date of Birth DT 8 YYYYMMDD

Patient Sex ST 1 M: male; F: female; U: unknown

Patient Race-Ethnic _
Origin

Patient Address _

Reserved Field _

Patient Telephone _
Number

Attending Physician ID _

Special Field 1 CM Format: <Age>^<Age Unit>

Element Max Length Format
Age 3 NM
Age Unit 1 ST

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 Height (in cm) _

Patient Weight(in kg) _

Patient's Known or _
Suspected Diagnosis

Patient Active _
Medications

Patient's Diet _

16
Practice Field No.1 _

Practice Field No.2 _

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 _

2.4.6.5. Test Order Record

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

Record Type ID (P) * ST 1 Use 'O'.

Sequence Number* NM 6 Indicates the sequence number of the Test Order

Record at the current layer. This record is in the
layer following the Patient Information Record and is
reset to 1 for each occurrence of a new Patient
Information Record. It is numbered consecutively; 1,

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)

Instrument Specimen ID* ST 2 Identification procedure for samples by the analyzer.

Format:

<Sample No>^<Tray No>^<Position

No>^^<Sample Type>^<Container Type >

Element Max Format

Length

Sample No 5 NM

Tray No 1 NM

Position No 2 NM

Sample 2 ST
Type

Container 2 ST
Type

Element Description

Sample No Confirmation number when

samples are numbered in
sequence in order of input. In
case of QC material, 'Control
Number * 1000+ Sequence No.

18
 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

Container SC: Standard cup

Type

Universal Test ID* CM 10 Repeat Field

(example: ^^^21^1\^^^22^1\^^^23^1)

Specifies test request.

Format: ^^^<Application Code>^<Dilution>

The first, second and third component elements for

this format are empty. These are referred to as the
Universal Test ID.
Value is reserved until Standard Code is made that
uniquely identifies the future tests.
This format is used repeatedly with delimiters when
ordering several tests. Maximum of 80 tests can be
specified.
Element Max Format
Length

Application 3 NM
Code

Dilution 3 ST

Element Description

Application The analyzer identifies the

Code test with max of 3-digit
numbers. Specify these
max of 3-digit numbers.
Dilution 1,2,5,10,20,50. When the
value is 1, testing is done

19
 using the standard analysis
parameters.

Priority* ST 1 Indicates the priority order of the Patient Samples.

Not used for Control Samples. Values are one of
the following:
Field Description
value

R Indicates routine analysis of the

patient samples
S Indicates Stat analysis of the
patient samples
(Empty) Control Samples

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 _

Action Code* ST 1 Indicates type of information for the report.

Value Sender Description

Q CLIA 1200Indicates report for the

control sample's
analytical data.
N CLIA 1200Indicates report for the
routine sample's
analytical data.
Danger Code _

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 _

User Field No. 2 _

Laboratory Field No. 1 _

Laboratory Field No. 2 _

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 _

Report Types* ST 1 Indicates type of communications.

Value Sender Description

O host Indicates request for the test

item.
F CLIA 1200 Indicates a report for the
analytical data.
Reserved Field _

Location or Ward of _
Specimen Collection
Nosocomial Infection _
Flag
Specimen Service _

Specimen Institution _

2.4.6.6. Comment Record

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

Record Type ID (C)* ST 1 Use 'C'.

Sequence Number* NM 6 Indicates the sequence number of the Test Request

Record in the current layer. Since this record is in
the layer following the Test Request Record, it is
reset to '1' each time a new Test Request Record is
presented and then numbered consecutively; 1, 2,
etc.
Comment Source ST 1 Indicates the source of the Comment. If issued by
the CLIA 1200, it is 'I', if issued by the host it is 'L'.
Comment Text NM 3 The number of a data alarm for measured
value is given.

Comment Type ST 1 'I' is used. It indicates that this record is a

result flag.

2.4.6.7. (Result Record)

Record to transmit analytical data.

R|1|^^^26/1/not|2.380| S/CO|||| F|||||

Max
Field Name Format Comments (Data Content)
Length

Record Type ID (R)* ST 1 Use 'R'.

Sequence Number* NM 6 Indicates sequence numbers for the Test Request

Record in the current layer. Since this record is the
layer that follows the Test Request Record, it resets
to 1 for each occurrence of a new Test Request
Record. It is numbered consecutively; 1, 2, etc., for
each occurrence of this record.
Universal Test ID* CM 22 Example: ^^^2/1/not

Specifies test request.

Format:

^^^<Application Code>/<Dilution>/<Pre-Dil.>

Max
Element Format
Length

22
 Application
3 NM
Code

Dilution 3 ST

Pre-Dilution 11 ST

Element Description

Application The analyzer identifies the test

Code with 3-digit numbers. Specify
these 3-digit numbers.
Dilution 1,2,5,10,20,50. When the value
is 1, testing is done using the
standard analysis parameters.
Pre-Dilution 'yes' or 'not'.

Data or Measurement ST 12 Measurement Result with decimal point. If

Value the measurement range is larger than the
upper limit of measuring range,' >' will
appear before the value; if lower than the
lower limit,' <' will appear before the value.

Example:

1.117

>1000.000

<2.000

Units ST 6 Indicates units of the analytical data.

Example:

IU/mL

mIU/mL

S/CO

Reference Ranges _

Result Abnormal Flags ST 2 Field Value Description

LL Lower than Repeat

Limit

HH Higher than Repeat

Limit

23
 L Lower value than
normal

H Higher value than

normal

A Abnormal

N Normal

_ Unused

Nature of Abnormality _
Testing
Result Status ST 1 Test times of analysis result

Field Value Description

F Indicates analytical data

from the first test
C Indicates analytical data
from the rerun
Date of Change in _
Instrument Normative
Values Units
Operator Identification ST 6 Identifies the operator. This field is not specified by a
host.
Date/Time Test Started _

Date/Time Test Started _

Instrument Identification _

2.4.6.8. Request Information Record

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

Format Max Comments (Data Content)

Field Name
Length

Record Type ID (R)* ST 1 Use 'Q'

Sequence Number* NM 6 Indicates the sequence numbers for the Test

Request Record in the current layer. Since this

24
 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>

Element Max Format

Length

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

Specimen Identification procedure

ID for samples by the
analyzer.
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. No.:CLIA
1200 sets the start as well
as end location according
to it and performs
numbering according to
initial sequence number.
Sample Confirmation number
No. when samples are
numbered in sequence in
order of input.
Tray No. ID of the Sample Tray with

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'

Nature of Request Time _

Limits
Beginning Request _
Results Date and Time
Ending Request Results _
Date and Time
Requesting Physician _
Name
Requesting Physician _
Telephone Number
User Field No. 1 _

User Field No. 2 _

Request Information O: Request for Test Request only. Inquiry is sent to

Status Codes a host from the analyzer using this code.

2.5. Communication Examples

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.

TS Inquiry / Realtime / Barcode - YES / CLIA 1200 to Host

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'

TS / Realtime / Barcode - YES / Host to CLIA 1200

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'

Routine Result / Realtime / Barcode - YES / CLIA 1200 to Host

CLIA 1200 #5'

HOST #6'
CLIA 1200 #2'1H|\^&|||CLIA 1200PLUS^1|||||host|RSUPL^REAL|P|1#13'P|1|||||||U||||||0^#13'O|1|0001
40940004|3^1^3^^S1^SC|^^^23^1\^^^24^1\^^^25^1\^^^26^1\^^^27^1|R||2014040910
5405||||N||||1|||||||20140409105307|||F#13'C|1|I|^^^^|G#13'R|1|^^^23/1/not|0.921|S/CO
||||F|||||#13'C|1|I|#23'2C#13'#10'
HOST #6'
CLIA 1200 #2'20|I#13'R|2|^^^24/1/not|716.058|mIU/mL||||F|||||#13'C|1|I|0|I#13'R|3|^^^25/1/not|0.9
19|S/CO||||F|||||#13'C|1|I|0|I#13'R|4|^^^26/1/not|1.220|S/CO||||F|||||#13'C|1|I|0|I#13'R|5
|^^^27/1/not|1.085|S/CO||||F|||||#13'C|1|I|0|I#13'L|1|N#13'#3'73#13'#10'
HOST #6'
CLIA 1200 #4'

Routine Result / Batch / Barcode - NO / CLIA 1200 to Host

CLIA 1200 #5'
HOST #6'
CLIA 1200 #2'1H|\^&|||CLIA
1200PLUS^1|||||host|RSUPL^BATCH|P|1#13'P|1|||||||U||||||#13'O|1||12^0
^3^^S1^SC|^^^24^1|R||20140411091533||||N||||1|||||||20140411095525|||F#13'C|1|I|^^
^^|G#13'R|1|^^^24/1/not|724.413|mIU/mL||||F|||||#13'C|1|I|0|I#13'L|1|N#13'#3'0D#13'#
10'
HOST #6'
CLIA 1200 #4'

QC Result / Realtime / CLIA 1200 to Host

CLIA 1200 #5'
HOST #6'

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'

QC Result / Batch/ CLIA 1200 to Host

CLIA 1200 #5'
HOST #6'
CLIA 1200 #2'1H|\^&|||CLIA 1200PLUS^1|||||host|RSUPL^BATCH|P|1#13'P|1|||||||U||||||#13'O|1||2^0^
32^^QC^SC|^^^7^1|R||20140403113032||||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'#3'18#13'#10'
HOST #6'
CLIA 1200 #4'

3. Appendix

3.1. Application Code and Application Corresponding

Table

Application Code Application Name

1 TSH
2 FT4
3 FT3
4 T4
5 T3
6 Anti_TG
7 Anti_TPO
8 LH
9 FSH
10 PRL
11 E2
12 Prog
13 T
14 μE3
15 Freeβ_HCG
16 AFP
17 CEA
18 CA125
19 CA15_3
20 CA19_9

28
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