CS-2000i/21000i

INTRODUCTION

Slide 1
Development of CS-2000i/2100i
 This instrument was developed based on CCPD.
CCPD = (Customer Centered Product Definition)

Partnership development of Dade Behring

and Sysmex. Global marketing research
was executed.
7 countries in Japan, US and Europe
Total 596 laboratories
WHAT ARE THE KEY IMAGES OF THE CUSTOMER DOES NOT FEEL IN CONTROL OF
OUR CUSTOMER’S ENVIRONMENT?THEIR DESTINY BECAUSE THEY ARE AT THE MERCY
OF THEIR CUSTOMERS AND THEY HAVE SO MUCH
GRIDLOCK TO DO WITH SO FEW RESOURCES
JUGGLER ON A HIGH WIRE
CHAOS EXISTS 5 P.M. ON FRIDAY AT RUSH HOUR
WHEN COMPUTER KENNEDY AIRPORT TRAFFIC JAM
SYSTEMS GO DOWN I AM GOING TO LOSE MY I AM NOT IN CONTROL THERE ARE NOT
JOB IF I CAN’T DO
ENOUGH PEOPLE TO
EVERYTHING
DO THE WORK
WE HAVE TO SHOUT
AT ONE ANOTHER
BECAUSE IT’S SO I AM EMBARRASSED

HIGH VOLUME OF
NOISY IN HERE WHEN CUSTOMERS THE ICEMAN
WHEN SUPERVISOR HAVE TO COME BACK IN
PARTS ARE RECEIVED DIDN’T GET THE RESULTS,
IN A.M. AND P.M. THEY GOT ANGRY AND I (OPERATOR) AM AT FEAR OF BEING
TOLD OUR BOSS THE BOTTOM OF THE REPLACED BY
LADDER MACHINE

SMOOTH OPERATION PROBLEM

TITLE WAVE OF PARTS I’M FRUSTRATED I DON’T TRUST
MAINTAINING TWO NOBODY CARES
AND NO ONE TO RUN THE SUPERVISOR WOULD BECAUSE I CANNOT GET AUTOMATION
SYSTEMS. NO IMPACT ABOUT ME. I’M A
THEM COME DOWN ON US IF ACCURATE RESULTS
ON ME; JUST BUTTON PUSHER
WE DIDN’T OFFER ON MY EQUIPMENT
COMPLAINING FOR A
FRIEND FLEXIBILITY
I FEAR REPLACEMENT
LAB IS WELL RUN -
BY AUTOMATION
YOU KNOW, IT’S
MILITARY
WORKERS WANT TO
WORK “BY THE CLOCK”
I AM STRESSED OUT
BUT WORK-FLOW
DOESN’T ALLOW TIME
FOR BREAKS
AUTO IS GOOD BUT I’M
THE WAY THINGS ARE EDUCATED AND NOT
TODAY, I NEED A LOT
OF ABBOTT HAIL MARY PASS AT FOOTBALL GAME BEING CHALLENGED

EQUIPMENT TO BOSS AND OPERATOR

PRODUCE RESULTS. AT EACH OTHER’S
SMALL LAB BUT FULL I’M RUNNING OUT OF AIR TRAFFIC CONTROLLER
I DON’T CARE WHAT THROATS
SERVICE. IT’S LIKE A SPACE TRYING TO FIGURE OUT WHAT
MACHINE THEY USE
GAS STATION SYSTEM IS SAYING
AS LONG AS I GET
RESULTS

I CAN’T DO MY JOB . . . MY
CUSTOMERS WILL LEAVE IF I
GET THE WRONG RESULT

IT MAKES ME LOOK BAD IF I

CAN’T GIVE AN ANSWER

= Top Vote Getter I NEED A SLIDE RULE TO

UNDERSTAND THIS STUFF
= Second Vote Getter
= Third Vote Getter

The design input has been extracted from

these investigations

Slide 2
 Concept of Development
 Achievement of a next generation platform which provides
various assays from screening tests to prevention of relapse.
(CS = Coagulation Station)
Next-generation (CS series)

CS-2000i
Function

CA-7000
CR-800
BCS
CA-6000
BCT
CA-1500
CA-500
Current lineup

Throughput capacity
Slide 3
Main Specifications (1)
CS-Series

Throughput (tests/h) PT: 180 tests/hour

PT and aPTT: 115 tests/hour
PT, aPTT, Fbg and ATIII: 100 tests/hour

Principles Multi-Wavelength Detection System: Transmitted Light Detection Method

▪ Clotting Assays: 405, 660, 800 nm (Percentage Detection Method)
▪ Chromogenic Assays: 405, 340 nm (Rate Method)
▪ Immunoassays: 575, 800 nm (Rate Method, VLin Method)

Detector 10 channels for Clotting Assays, Chromogenic Assays and Immunoassays

(4 channels for Aggregation Assays)
▪ The transmitted light (or A/D value) is detected every 0.1 seconds.
▪ Maximum Reading Time is 1800 seconds.

Sample Quality Check HIL (Hemolysis, Icterus and Lipemia) Flag

Wavelength Switching Automatically selects the appropriate wavelength
New Parameter Factor XIII
Data Storage 10,000 sample results with reaction curves

Slide 4
Main Specifications (2)
CS-Series

Auto Sampler Capacity of 50 samples (Rack Type)

STAT 5 holders

Reagent Holder 40 positions (10°C), 5 positions (room temperature)

Reagent ID Automatically reads the reagent barcode

Sample Volume PT, APTT = 50 ul FXIII = 20ul

Fbg = 10 ul PC = 15ul
TT = 100 ul DD = 16ul
Extrinsic / Intrinsic Factors = 5ul VWFAg = 10ul
ATIII, α2-AP, PLG = 16 μL
PAI = 10 ul

Calibration Curve Max. 250 parameters

Max. 10 lots of reagent/parameter
Max. 10 calibration curves/lot
Max. 12 points

Reaction Tubes Automatically supplied from an internal hopper. Capacity: 500 tubes

Slide 5
Main Specifications (3)
CS-Series

Quality Control X Control, Levey- Jennings Control

Multi-rule (Westgard) monitoring
1200 data points x 750 parameters in memory

Sample Aspiration The sample probe, with the surface liquid level sensor, quantitatively
aspirates plasma from a centrifuged whole blood samples.

Dimensions Main Unit:

W x H x D (mm) Approx. 775 x 865 x 675 (mm) Approx. 100 (kg)
Weight (kg) Pneumatic Unit:
Approx. 280 x 400 x 355 (mm) Approx. 17.0 (kg)

Power Consumption Main Unit : 800VA max Pneumatic Unit : 280VA max

Installation mode Desktop

Optional instrument Graphic /Data printer

Slide 6
CS-2000i/2100i

FEATURES & BENEFITS

Slide 7
Feature 1– Multi-wavelength Detection system

CS-2100i
• Fully automated
• Optical fiber supplies light at 5 different wavelengths
• Detector can receive light in all 5 wavelengths
• Can simultaneously measure multiple parameters of
clotting, chromogenic and immunoassay methods
• Can identify sample interference using this multi-wavelength
system.

This feature translates to accuracy and efficiency in a

busy lab that handles high volume samples and
specialized testing parameters

Slide 8
Feature 2 – HIL Detection System

CS-2100i
• Perform a sample quality check for interfering
substances (Hemolysis, Icterus, Lipemia) prior to
testing.

• “Wavelength Switching” system automatically

switches to a default sub-wavelength should a light
volume error or slight coagulation error occurs on
clotting assay.

The Sample Quality check function helps to identify

problematic samples. End-users have a chance to
report safe and accurate patient’s results by either
rejecting, repeating or re-diluting the problematic
samples

Slide 9
Feature 3 – Multipurpose Detector

CS-2100i
• 10 incubation and 10 measurement channels
• 4 out of 10 measurement channels equipped with
rotating magnet for aggregation assays
• High throughput

For laboratories that perform many specialized chromogenic

and immunologic parameters, a high throughput can still be
achieved with use of all the detection channels the Multi-
Wavelength Detection system.

Slide 10
Feature 3: Multipurpose Detector

Slide 11
Feature 4 – Cooled Reagent System

CS-2100i
• Specially designed reagent rack system
• Reagent bottles are slightly tilted so dead volume is
greatly reduced.
• Double-ring reagent table can hold 40 reagent bottles
• Reagent tables are cooled at 10oC.
• One position in each reagent rack has stirring function
• Multiple vials (up to 3 vials) of same reagent can be
loaded

Helps ensure stability of reagents thus maintaining high

quality performance of the reagents with minimal
wastage. This translates to cost saving.
Multiple-vial capacity gives flexibility to busy
laboratories with high sample volume.

Slide 12
Feature 5- Stat Sampling Option

CS-2100i
• Option for running STAT samples
• 5 dedicated STAT positions
• Interrupt functions for emergency testing

Offers flexibility to end-users and added value for patients

A stat sample (routine or special testing) can be prioritized

and run within minutes. This can make a difference to
patient whose treatment depends on the test result.

Slide 13
Feature 6. Unique Sample Cuvette
CS-2100i
• Utilizes a uniquely designed cuvette
• Square at the top and round at the bottom
• Increase homogenous mixing of the reagents and the
sample mixture.
• With a tiny stirrer bar, the same cuvette can be used for
aggregation assays.

Good homogenous mixing of sample and reagents before

measurement ensures highly accurate and reproducible
results.

Slide 14
Feature 7: Simultaneous test analysis

CS-2100i
• Can perform simultaneous analysis of routine and
specialized test parameters
• Maximum of 60 Assay Groups.

This feature offers the end-users flexibility for a true

walk-away system.

Slide 15
Feature 8. Instrument Maintenance Management

CS2100i
• Maintenance screen can display history of regular maintenance
done
• A maintenance management checklist
• Maintenance report can be printed.

Offers convenience as the instrument automatically

‘registers’ any maintenance done and also provides ‘proof
of documentation’ needed in the upkeep of the instrument.

Slide 16
Feature 9: Automatic Reflex test
CS2100i
• Pre-set conditions or reflex tests can be programmed
• Automatically performs another test parameter to provide further
information on the abnormal sample.

This feature acts like a “consultant” which enhances the

“intelligence” of the lab by giving options in investigating a
particularly abnormal sample without disturbing the ever-
busy pathologist or hematologist. This raises the confidence
of the end users to release abnormal results.

Slide 17
Feature 10. Cap-piercing capability (Optional)

CS-2100i
• Has an option for a cap piercer
• Eliminate the need to remove caps from coagulation samples.

This feature offers safety to the end-users by avoiding the

need to open up the coagulation sample for a test to be
analyzed.

Slide 18
Feature 11. Extended and Expanded Calibration system

CS-2100i
• Provides 12 data points (max.) for each calibration done for
a 250 parameters (max.)
• Can keep 10 calibration sets per lot of reagent
• Up to 10 lots of reagents can be accommodated per
parameter.

Useful for labs that needs to keep a record of the calibration

done for a particular lot/lots. Can compare curves to detect
if any significant ‘shifting’ has occurred.

The 12 data points also exceed CLSI requirement to have

at least 7 dilution points in determining linearity range of a
particular instrument system.

Slide 19
Feature 12. Methodical QC system

CS-2100i
• Reliable QC checks using either X-control, Levey-
Jennings control or Multi-rule (Westgard Rule) monitoring
• A maximum of 1200 data points can be stored at any one
time.

Can continuously monitor the performance of the whole

system. A graphical record of the QC data enables users
to spot easily if there’s a ‘shift’ or ‘trend’ thus ensuring
reliable results.

Slide 20
Feature 13. Automatic Repeat, Re-analysis and Re-dilution

CS-2100i
• Automatically perform re-analysis and re-dilution as and when necessary for
samples that exceed set limits

This translates to reliable and accurate results.

Slide 21
Feature 14: MDA Function
CS-2100i
• Can analyze samples using multiple dilution ratio
• Especially useful when presence of inhibitors are suspected.

Like a consultant, this feature guides the user on what

step to take when the patient’s sample showed the
presence of inhibitor. This translates to time-saving.

Slide 22
Design and Function

Main unit IPU

(Information Processing Unit)

Slide 23
 CS-2000i/2100i

Main unit
Cuvette Hopper

Light Shield START button

Reagent Table Emergency STOP

button

STAT/Diluent Table

Sampler
Cuvette Trash
Tray

Slide 24
CS-2000i/2100i
IPU
(Information Processing Unit)

17” Touch screen

monitor

Desktop PC

Keyboard

Slide 25
 CS-2000i/2100i

 Main Unit  17 inch touch panel display

 IPU

 Sampler
(50 samples) Rinse tank
(20L)

 Pneumatic Unit

Slide 26
Data Calculation Flow

Slide 27
CS-2000i/2100i

TECHNOLOGY
MEASUREMENT PRINCIPLE

Slide 28
Measurement Principle

Sample dispensing Reagent addition

Reaction curve

Incubation Detection

Primary Cuvette Mixing

tube

Light is shined onto the sample and reagent mixture.

Changes in transmitted light are detected during the process of

•Change in turbidity when fibrinogen is converted into fibrin (clotting assays)

•Color emission by a chromogenic synthetic substrate (chromogenic assays)
•Latex agglutination by antigen-antibody reaction (immunoassays)

Slide 29
Multi-Wavelength Detection System

Photo-diode Multi-Wavelength Detection System

▪ Transmitted Light Detection
Method

Assay Method
Lamp Unit
▪ Clotting Assays: 405, 660, 800nm
(Percentage Detection Method)

340nm
405nm ▪ Chromogenic Assays: 405, 340nm
575nm
660nm
(Rate Method)
800nm
Optical fiber ▪ Immunoassays: 575, 800nm
(VLin Method)
Multi-Wavelength
Filter

Slide 30
New Detector Platform
Clotting assay Chromogenic assay Immunoassay Aggregation assay

660nm 405nm 800nm or 575nm 575nm or 800nm

Scattered light Transmitted light Transmitted light Transmitted light

Multi-Purpose Detector

Multi-Wavelength Filter Common Detector Mixing Function

Channels

Slide 31
 Comparison of Detectors

CA-1500 CS-2100i
Measurable parameters are limited by
the number of detector channels. 340, 405,
340, 405, 575, 575,
660 660
andand 800nm
800nm

Incubation unit Detection unit

Incubation unit Detection unit

All channels are available for use for

clotting, chromogenic and immunoassays.
Only 4 channels for aggregation assay

Slide 32
Reaction Curve of CA-Series

Slide 33
Reaction Curve of CS Series

0%
A/D value of photometry

Start point

Change in A/D value

50%

100%
End point of reaction

Clotting time Time

Slide 34
Reaction Curve of Clotting Assay
PT with Normal Sample
2500

2000 800nm

1500 660nm
AD

575nm
1000

500
405nm
340nm
0
0 20 40 60 80 100 120
Time (sec.)

The reaction curve and clotting time are almost the same at each wavelength for a normal sample.
But, the dH, base line (bH) and end line (eH) have different AD values depending on the wavelength.

Slide 35
Reaction Curve of Clotting Assay
PT with Lipemic Sample
1000

800

600
AD

400
800nm
200
660nm
0
0 20 40 60 80 100
Time (sec.)

The reaction curves were able to be obtained at only 800nm and 660nm with a lipemic sample.
The dH at 800 nm is larger than that at 660 nm. This wavelength is most effective for measuring
such a sample.

Slide 36
Reaction Curve of Clotting Assay
APTT with Lipemic Sample
1000

800

600
AD

400
800nm
200
660nm
0
0 30 60 90 120

Time (sec.)

APTT can also generate a larger dH at 800nm with a lipemic sample.

Slide 37
Reaction Curve of Clotting Assay
Fbg with Normal Sample

3500

3300
660nm
3100
AD

2900
405nm

2700

2500
0 20 40 60 80 100
Time (sec.)

Fbg can generate a larger dH at 405nm than at 660nm with a normal sample.

Slide 38
Reaction Curve of Clotting Assay
Fbg with Lipemic Sample

3000

2000 660nm
AD

1000

405nm

0
0 20 40 60 80 100
Time (sec.)

Because measurement at 405 nm is affected by a lipemic sample, 660nm is better than 405nm in
this case.

Slide 39
Reaction Curve of Clotting Assay
Fbg with Hemolyzed Sample

4000

660nm
3000
AD

2000

1000

405nm
0
0 20 40 60 80 100
Time (sec.)

Because measurement at 405 nm is also affected by hemolyzed and icteric samples, 660nm is
better than 405nm in these cases.

Slide 40
Reaction Curve of Clotting Assay

CLOTTING DEFAULT SUB-

ASSAY WAVELENGTH WAVELENGTH

PT, APTT 660nm 800nm

Fibrinogen
(Clauss 405nm 660nm
Method)

Slide 41
Reaction Curve of Chromogenic Assay
ATIII with Normal Sample

2500

2000
340nm
1500
dOD

1000
405nm
500

0 575, 660, 800nm

0 10 20 30 40 50
Time (sec.)

Chromogenic assays measure the change in absorption of a specific chromogenic substrate at 405nm.

Slide 42
Reaction Curve of Chromogenic Assay
FXIII with Normal Sample
3000

2500
dOD

2000
340nm

1500

0
0 100 200 300 400 500 600 700
Time (sec.)

Factor XIII uses the principle of NADH measurement at 340nm.

Slide 43
Reaction Curve of Immunoassay
D-Dimer with Normal Sample
3000

2500

2000 340nm
dOD

1500 405nm

1000
575nm
500 660nm
800nm
0
0 40 80 120 160 200
Time (sec.)

The reaction curves at 340 and 405 nm contain a lot of noise for the D-Dimer assay.
The wavelengths of 575, 660 and 800nm are suitable for immunoassays. However, the
optimum wavelength has a close connection to the latex size and the assay parameter being
measured.

Slide 44
Reaction Curve of Aggregation Assay

vWF:RCoF with Normal Sample

1100

1000
mAbs

900
800nm

800
0 30 60 90
Time (sec.)

vWF:RCoF detects the transmitted light intensity at 800nm. Because the mixture of sample
and reagent is mixed by a stir bar during the reaction, the reaction curve becomes noisy.

Slide 45
Advantage of the Multi-Wavelength Detection System

Advantage

 All detector channels are available for use for clotting assays,
chromogenic assays and immunoassays. Additionally 4 of
these wells are available for use for aggregation assays.
 Measurable parameters are not limited by the detector well,
so the throughput is improved compared with the CA-1500
system.
 Because CS measures the sample at multiple wavelengths,
the optimum wavelength can be selected according to the
sample characteristics.
 This system includes application of the HIL Check function
that checks for the presence of interfering substances in the
sample.

Slide 46
Wavelength Switching Function

Default Wavelength
660nm ► 800nm
or
405nm ► 660nm

Transmitted Light High Error

Turbidity Level Over Error
Slight Coagulation Error Wavelength
Switch

Sub- Wavelength
Cannot obtain data due to
a measurement error!

Can obtain result without an error!

Slide 47
Wavelength Switching Function
Effective for lipemic samples and
low fibrinogen samples

Slide 48
Wavelength Switching Flow

Analysis at the Default Wavelength Clotting method: 660nm

Fibrinogen method: 405nm

Check
“Light Volume Error”
“SC Error”

Switch wavelength
Analysis at the Sub-Wavelength Clotting method: 800nm from 660nm
Fibrinogen method: 660nm from 405nm

Check
“Light Volume Error”
“SC Error”

Comparison of the dH between the sub-

wavelength and the default wavelength.
Report
The system selects the higher dH.

Slide 49
Wavelength Switching
PT with Lipemic Sample

1000

800

600
AD

400
800nm Obtain result !
200
660nm SC Error
0
0 20 40 60 80 100
Time (sec.)

Default Wavelength Sub Wavelength

660nm 800nm

Slide 50
Wavelength Switching
Fbg with Lipemic Sample
3000

660nm Obtain result!

2000
AD

1000

405nm SC Error

0
0 20 40 60 80 100
Time (sec.)

Default Wavelength Sub Wavelength

405nm 660nm

Slide 51
Wavelength Comparison: PT at 660nm and 800nm

Scatter Plot Bias

50 1

800nm sub-wavelength (sec.)

800nm sub-wavelength (sec.)

40
0.5

30

20

-0.5
10

0 -0.1
0 10 20 30 40 50 0 10 20 30 40 50
660nm default wavelength (sec.) 660nm default wavelength (sec.)

Regression Analysis
R 0.9999
Slope 1.000
Intercept 0.10

Slide 52
Wavelength Comparison: Fbg at 405nm and 660nm

Scatter Plot Bias

1.5
20

660nm sub-wavelength (sec.)

660nm sub-wavelength (sec.)

1.0

15
0.5

0.0
10

-0.5
5
-1.0

0 -1.5
0 5 10 15 20 0 5 10 15 50
405nm default wavelength (sec.) 405nm default wavelength (sec.)

Regression Analysis
R 0.9971
Slope 1.000
Intercept 0.20

Slide 53
Data Calculation Flow

Slide 54
CS-2000i/2100i

SMOOTHING

A process of eliminating noise signal

from the raw photometry data

Slide 55
Smoothing
CS Series has 3 filtering methods

Method Description

Reference Curve Filtering Can remove oscillation/ fluctuation from

light source

Median Value Filtering Can remove sudden/ unexpected noise

elements

Moving Average Filtering Can remove regularly occurring/

stationary noise elements

Slide 56
Reference Curve Filtering

This method removes fluctuations/ oscillations noise in the light source

Slide 57
Median Value Filtering

This method removes unexpected / sudden noise in the light source

Slide 58
Moving Average Filtering

This method removes stationary/regularly occurring noise in the light

source

Slide 59
Data Calculation Flow

Slide 60
CS-2000i/2100i

EVALUATION ALGORITHM

Slide 61
Evaluation Algorithm
CS Series has 3 evaluation algorithms
Evaluation Method Description

Percentage Detection Method Used for evaluation of Clotting Assays

The clotting time is measured.

Rate Method Used for evaluation of Chromogenic

Assays and Immunoassays
The change in light absorbance is
calculated.

VLin Integral Method Used for evaluation of Immunoassays

The change in light absorbance is
calculated

Slide 62
Percentage Detection Method

Start point of reaction

0%
A/D value of photometry

Change in A/D value (dH)

50%

End point of reaction

100%

Clotting time Time

This method allows determination of the coagulation time even for those samples
demonstrating only a slight change in transmitted light intensity (low fibrinogen
samples) or samples whose speed of change is only slight (samples with
prolonged coagulation time)

Slide 63
Percentage Detection Method
Detailed evaluation algorithm

1. SEARCH FOR BASELINE

To search for the reaction start point after the reagent is added. The
search time begins after the “Mask Time”. The amount of A/D value at
the detection point is defined as 0% (baseline).

Slide 64
Percentage Detection Method
Baseline Searching Method

The point of maximum A/D value in the “Min. Search Time” range
after the “Mask Time” is defined as the baseline

Slide 65
Percentage Detection Method
Detailed evaluation algorithm

2. SEARCH FOR END POINT

Begins to search for the reaction end point when A/D value reaches the
Reaction Start Level until the “Maximum Reading Time” that was preset in
the test protocol. The amount of A/D value at the detection point is defined
as 100%.

Slide 66
Percentage Detection Method
End Point Searching Method

Method 1 (Conventional)
The end point is defined as the point where the reaction end angle < specified
value. It will search from “Reaction Start Point” to “Maximum Reading Time”
point

Slide 67
Percentage Detection Method
End Point Searching Method

Method 2
Compares the slope of the reaction curve every 0.1 seconds. The end point is
defined as the point where the slope ratio (Slope2/Slope1) < specified value. It
will search from “Reaction Start Point” to “Maximum Reading Time” point

Slide 68
Percentage Detection Method
End Point Searching Method

Method 3
Compares the areas between the baseline and the reaction curve every 0.1 secs.
The end point is defined as the point where the area ratio (S2/S1) < specified
value. It will search from “Reaction Start Point” to “Maximum Reading Time” point.
Effective for defining end point of low Fbg samples that have low A/D value.

Slide 69
Percentage Detection Method
Detailed evaluation algorithm

3. DEFINE CLOTTING TIME

Between the detection points of 0% and 100%, the time when the amount
of A/D value reached 50% level is defined as the clotting time.

Slide 70
Rate Method

Change in absorbance between the prescribed Start Time

and End Time (linear range) is used to draw the linear
regression line. The change in absorbance per unit time
(dOD/min) is calculated from the slope of the regression line.

Slide 71
Rate Method

Detailed evaluation algorithm

1. Light at 405nm or 575nm or 340nm is irradiated on

the sample and the light intensity transmitted through
the sample is detected by photo detector during the
measurement time.

2. The light intensity is converted to digital data whose

range is 0 to 4095 ie 4096 levels by the electrical
circuit. We called this the digital data A/D value
(analog-to-digital conversion value)

Slide 72
Rate Method

Detailed evaluation algorithm

3. The A/D value is converted to a common logarithm

by the software. We call this value the transmitted
light value.

4. By plotting the transmitted light values in the linear

range set for the detector, we achieve a straight line
that indicate time-variance of the transmitted light
value by linear approximation

Slide 73
Rate Method

Detailed evaluation algorithm

5. The dOD/min is calculated from the slope of this

straight line and is reported as the dOD value.
Also, A/D value at the start point of the linear range
is reported as the baseline.

Slide 74
VLin Integral Method

VLin Integral is an evaluation method for a reaction kinetic

curve that outputs the steepest increase of the curve as
the raw value.

Slide 75
VLin Integral Method

Detailed evaluation algorithm

1. Maximum Reaction Speed Point Search

The raw data between the start time and the end time of the reaction curve
is fitted to a polynomial degree. The time (TVmax) for the maximum change
in absorbance (reaction speed) is calculated by the 1st derivative curve.

Slide 76
VLin Integral Method

Detailed evaluation algorithm

2. Linear Range Search

With the maximum reaction speed time (TVmax) as the base point, the linear
range is determined by extending the range using the difference (diff)
between the regression curve and tangent line at the base point.

Slide 77
VLin Integral Method
Detailed evaluation algorithm

3. Calculating change in the absorbance

The light absorbance in the linear range is linearly regressed by the least
square expression and then the change in light absorbance per unit of time
is calculated by the slope.

Slide 78
CS-2000i/2100i

HIL CHECK FUNCTION

Slide 79
HIL Detection System
The HIL detection system requires 100ul of plasma and a cuvette.
It checks for interfering substances at 405nm, 575nm and 660nm
wavelengths before sample analysis begins.

Multi-Wavelength Detector

Lamp unit

HIL Detector

405nm
575nm
660nm

Slide 80
HIL Detection - Principle

Slide 81
HIL Detection - Principle

Slide 82
HIL Check Flow

A/D value is converted into absorbance

Check on absorbance at 660 nm

Check Lipemia Absorbance > “L” threshold
► Flag: Error 1000.3000.0000 (Lipemic Sample)

Check on absorbance at 575 nm

Check Hemolysis Absorbance - “L” value (575nm) > “H” threshold
► Flag: Error 1000.2000.0000 (Hemolysed Sample)

Check on Abs. at 405 nm

Check Icterus Absorbance - “L” value (405nm) - “H” value (405nm)
> “I” threshold
► Flag: Error 1000.2000.0000 (Icteric Sample)

Flag

Slide 83
HIL SAMPLE CHECK - ANALYSIS
Various concentrations of interfering substances are made by
Interference Check A Plus (Sysmex) and normal pooled plasma.

Analysis results on CS-2100i and H-7180 (Hitachi)

Slide 84
HIL SAMPLE CHECK - ANALYSIS

Slide 85
HIL Detector - Settings

Slide 86
HIL Detector - Settings

Check Level Absorbance Hb mg/dl Bilirubin mg/dl Intra Lipid (%)

0 0.0 – less than 0.6 0-60 0-1.2 0-0.06

1 0.6 – less than 1.2 60-120 1.2-2.4 0.06-0.12

2 1.2 - less than 1.8 120-180 2.4-3.6 0.12-0.18

3 1.8 - less than 2.4 180-240 3.6-4.8 0.18-0.24

4 2.4 - less than 3.0 240-300 4.8-6.0 0.24-0.30

5 3.0 - less than 3.6 300-360 6.0-7.2 0.30-0.36

Slide 87
 Correlation Between HIL Check and
Quantitative Value

Hemoglobin Bilirubin Triglycerides

4 4 4
(575nm) (405nm (660n
) m)
3 3 3
Abs.

Abs.

Abs.
2 2 2

1 1 1

0 0 0
300 450 600 750 900 300 450 600 750 900 300 450 600 750 900
λ λ λ

1.500 2.500 2.500

n=9 n = 29 n = 28
y = 0.007x + 0.251 y = 0.299x - 0.092
CS-2000i : Absorbance 575nm

CS-2000i : Absorbance 660nm

CS-2000i : Absorbance 405nm

y = 0.364x + 0.046
2.000 r = 0.887 2.000 r = 0.839
r = 0.990
1.000
1.500 1.500

1.000 1.000
0.500

0.500 0.500

0.000 0.000 0.000

0.0 1.0 2.0 3.0 4.0 0 100 200 300 0.0 2.0 4.0 6.0
HemoCue: Hb (g/L) COBAS-MIRA: Bilirubin (µmol/L) COBAS-MIRA: Triglycerides (mmol/L)

Slide 88