Automated Blood Coagulation Analyzer Reproducibility and Standardization Data

Automated Blood Coagulation Analyzer CA-50
Basic Data Sheet -(PT)
1) Reproducibility
2) Day-to-day reproducibility
3) Standard Curve
4) Correlation
5) Interference testing
6) Difference of results between
analysis channels
To readers of this scientific data
Due to measurement conditions and nature of the speci

* men, different results from this sheet might be observed.
Sysmex corporation
Scientific division
4-4-4 Takatsukadai, Nishi-ku, Kobe 651-2271 JAPAN
Tel : 078-991-1911
Fax : 078-991-1917
E-mail address : scientific@sysmex.co.jp
1
CA-50
1)-1 Reproducibility - (PT) using Thromborel S
Results
Normal Abnormal Control Plasma N Control Plasma P

pooled plasma pooled plasma
sec % sec % sec % sec %
1 10.0 99.5 15.9 48.3 10.8 88.3 20.7 34.9
2 10.0 99.5 15.9 48.3 10.8 88.3 20.4 35.4
3 10.1 98.0 15.9 48.3 10.9 87.0 20.6 35.1
4 10.0 99.5 16.2 46.9 10.8 88.3 20.4 35.4
5 10.0 99.5 15.7 49.2 10.6 90.9 20.7 34.9
6 9.9 101.1 16.0 47.8 10.6 90.9 20.7 34.9
7 10.1 98.0 16.2 46.9 10.8 88.3 20.8 34.7
8 10.0 99.5 15.9 48.3 10.8 88.3 20.6 35.1
9 10.0 99.5 16.0 47.8 10.6 90.9 20.8 34.7
10 9.9 101.1 15.6 49.7 10.9 87.0 20.5 35.2
Mean 10.00 99.52 15.93 48.15 10.76 88.82 20.62 35.03

SD 0.063 0.981 0.179 0.835 0.111 1.448 0.140 0.241
CV(%) 0.63 0.99 1.12 1.73 1.03 1.63 0.68 0.69
Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > Thromborel S Lot No. 505453
Specimens (1) Normal pooled plasma
(2) Abnormal pooled plasma
(3) Control Plasma N Lot No. 502704B
(4) Control Plasma P Lot No. 512645B
Comment
Normal plasma (normal pooled plasma and Control Plasma) and abnormal plasma (abnormal
pooled plasma and Control Plasma P) were measured 10 times consecutively using Thromborel
S to test within-run reproducibility.
Results were excellent and the CVs were less than 2.00%.
2
CA-50
1)-2 Reproducibility - (PT) using Thromborel S
Results
Ci-Trol Level 1 Ci-Trol Level 2 Ci-Trol Level 3
sec % sec % sec %

1 11.0 85.8 36.8 18.3 61.1 10.3
2 10.8 88.3 36.7 18.3 60.7 10.4
3 11.0 85.8 35.8 18.8 60.6 10.4
4 11.0 85.8 36.3 18.5 60.9 10.4
5 11.0 85.8 36.3 18.5 59.7 10.6
6 10.6 90.9 36.5 18.4 60.0 10.5
7 10.9 87.0 36.6 18.4 59.5 10.6
8 10.6 90.9 36.1 18.7 60.2 10.5
9 10.6 90.9 36.0 18.7 60.5 10.4
10 10.8 88.3 36.8 18.3 60.7 10.4
Mean 10.83 87.95 36.39 18.49 60.39 10.45

SD 0.168 2.139 0.330 0.176 0.497 0.092
CV(%) 1.55 2.43 0.91 0.95 0.82 0.88

Specimens (1) Ci-Trol Level 1 Lot No. COL1-1010

(2) Ci-Trol Level 2 Lot No. COL2-536
Comment
Ci-Trol Level 1, 2 and 3 were measured 10 times consecutively using Thromborel S to test
within-run reproducibility.
3
CA-50
1)-3 Reproducibility - (PT) using Thromboplastin•C Plus
Results

1 10.3 114.1 13.3 52.1 10.8 98.6 15.2 39.4
2 10.3 114.1 13.3 52.1 10.8 98.6 15.5 37.9
3 10.4 110.8 13.4 50.9 10.7 101.5 15.6 37.5
4 10.3 114.1 13.3 52.1 10.7 101.5 15.4 38.4
5 10.3 114.1 13.6 48.6 10.7 101.5 15.7 37.0
6 10.3 114.1 13.4 50.9 10.8 98.6 15.4 38.4
7 10.3 114.1 13.4 50.9 10.9 95.9 15.2 39.5
8 10.3 114.1 13.2 53.3 10.6 104.5 15.3 38.9
9 10.3 114.1 13.2 53.3 10.8 98.6 15.2 39.4
10 10.4 110.8 13.3 52.1 10.7 101.5 15.7 37.0
Mean 10.32 113.44 13.34 51.63 10.75 100.08 15.42 38.34

SD 0.040 1.320 0.111 1.313 0.081 2.320 0.189 0.917
CV(%) 0.39 1.16 0.83 2.54 0.75 2.32 1.22 2.39

< Reagents > Thromboplastin•C Plus Lot No. TPC-401

Comment
Normal plasma (normal pooled plasma and Control Plasma N), abnormal plasma (abnormal
pooled plasma and Control Plasma P) were measured 10 times consecutively using Thrombo
plastin•C Plus to test within-run reproducibility.
4
CA-50
1)-4 Reproducibility - (PT) using Thromboplastin•C Plus
Results
sec % sec % sec %

1 10.7 101.5 21.9 19.7 31.0 10.2
2 10.8 98.6 22.4 18.9 31.0 10.2
3 10.8 98.6 22.6 18.6 30.7 10.4
4 10.8 98.6 22.1 19.4 30.9 10.3
5 10.7 101.5 22.3 19.1 31.0 10.2
6 10.7 101.5 22.1 19.4 30.5 10.6
7 10.8 98.6 21.8 19.9 30.1 10.8
8 10.7 101.5 22.0 19.5 31.0 10.2
9 10.7 101.5 22.1 19.4 30.6 10.5
10 10.7 101.5 21.9 19.7 30.5 10.6
Mean 10.74 100.34 22.12 19.36 30.73 10.40

SD 0.049 1.421 0.236 0.375 0.290 0.205
CV(%) 0.46 1.42 1.07 1.94 0.94 1.97


Comment
Ci-Trol Level 1, 2 and 3 were measured 10 times consecutively using Thromboplastin•C Plus
to test within-run reproducibility.
5
CA-50
1)-5 Reproducibility - (PT) using Innovin
Results

1 12.3 99.7 16.8 47.8 12.6 94.2 21.2 33.4

2 12.3 99.7 16.8 47.8 12.7 92.5 21.1 33.6
3 12.3 99.7 16.8 47.8 12.6 94.2 20.8 34.4
4 12.4 97.8 17.3 45.7 12.7 92.5 20.8 34.4
5 12.3 99.7 16.9 47.4 12.5 96.0 21.5 32.7
6 12.3 99.7 17.1 46.5 12.7 92.5 21.4 32.9
7 12.3 99.7 16.8 47.8 12.5 96.0 21.3 33.1
8 12.3 99.7 17.2 46.1 12.8 90.8 20.9 34.1
9 12.3 99.7 17.0 46.9 12.7 92.5 21.4 32.9
10 12.3 99.7 16.8 47.8 12.6 94.2 20.8 34.4
Mean 12.31 99.51 16.95 47.16 12.64 93.54 21.12 33.59
SD 0.030 0.570 0.180 0.766 0.092 1.589 0.264 0.652
CV(%) 0.24 0.57 1.06 1.62 0.73 1.70 1.25 1.94

< Reagents > Innovin Lot No. 526903

Comment
Normal plasma (normal pooled plasma and Control Plasma N) and abnormal plasma (abnormal
pooled plasma and Control Plasma P) were measured 10 times consecutively using Innovin to
test within-run reproducibility.
6
CA-50
1)-6 Reproducibility - (PT) using Innovin
Results
sec % sec % sec %

1 12.8 90.8 32.1 17.6 49.3 9.1
2 12.9 89.1 32.2 17.5 49.7 8.9
3 12.8 90.8 32.3 17.4 49.6 9.0
4 12.8 90.8 31.9 17.7 49.3 9.1
5 12.8 90.8 32.1 17.6 50.4 8.8
6 12.8 90.8 31.7 17.9 49.1 9.1
7 12.8 90.8 32.0 17.7 49.7 8.9
8 12.8 90.8 31.9 17.7 49.2 9.1
9 12.8 90.8 31.7 17.9 49.8 8.9
10 12.8 90.8 32.6 17.2 49.1 9.1
Mean 12.81 90.63 32.05 17.62 49.52 9.00

SD 0.030 0.510 0.262 0.204 0.384 0.110
CV(%) 0.23 0.56 0.82 1.16 0.78 1.22

• Chip : Eppendorf 300 µL chip Lot No. 526903
< Reagents > Innovin
Lot No. COL1-1010
(3) Ci-Trol Level 3
Comment
Ci-Trol Level 1, 2 and 3 were measured 10 times consecutively using Innovin to test within-
run reproducibility.
7
CA-50
2) Day-to-day reproducibility - (PT) using Thromboplastin•C Plus
Results
1 st 2 nd 3 rd 4 th 5 th Total
1 11.1 11.1 11.2 11.0 11.3
2 11.2 11.3 11.1 11.1 11.2
3 11.1 11.2 11.2 11.0 11.3
4 11.1 11.2 11.3 11.0 11.1
5 11.0 11.1 11.0 10.9 11.2
Mean 11.10 11.18 11.16 11.00 11.22 11.13
SD 0.063 0.075 0.102 0.063 0.075 0.076
CV(%) 0.57 0.67 0.91 0.57 0.67 0.68
(sec)
(sec)
12.0
Clotting time
11.5
11.0
10.5
10.0
1 2 3 4 5 (days)
Time

Specimens Ci-Trol Level 1 Lot No. COL1-1010
Comment
Ci-Trol Level 1 (normal rage plasma) was measured for PT on 5 consecutive days using
Thromboplastin•C Plus to test day-to-day reproducibility.
Results were excellent, and CVs 1.00% or less was achieved for each plasma.
8
CA-50
3)-1 Standard Curve - (PT) using Thromborel S
Results
Dilution ratio 1/1 4/5 3/5 2/5 1/5

Activity (%) 96.0 76.8 57.6 38.4 19.2
Clotting time (sec) 10.7 12.5 16.3 25.1 52.1
Log.Pt.Pt

Reference Standard Human Plasma Lot No. 502567B

plasma
Dilution Owren's veronal buffer

Comment
The standard curve of PT Activity was set up, using Thromborel S and Standard Human Plas
ma. Good standard curve was provided with the plasma activity set at 96%.
9
CA-50
3)-2 Standard Curve - (PT) using Thromboplastin•C Plus
Results
Dilution ratio 1/1 4/5 3/5 2/5 1/5

Activity (%) 99.0 79.2 59.4 39.6 19.8
Log.Pt.Pt

< Reagents > Thromboplastin•C Plus Lot No. 527019

plasma

Comment
The standard curve of PT Activity was set up, using Thromboplastin•C Plus and Standard Hu-
man Plasma. Good standard curve was provided with the plasma activity set at 99%.
10
CA-50
3)-3 Standard Curve - (PT) using Innovin
Results
Dilution ratio 1/1 4/5 3/5 2/5 1/5

Activity (%) 94.0 75.2 56.4 37.6 18.8
Log.Pt.Pt


plasma

Comment
The standard curve of PT Activity was set up, using Innovin and Standard Human Plasma.
Good standard curve was provided with the plasma activity set at 94%.
11
CA-50
4)-1 Correlation - (PT sec) using Thromborel S
Results
CA-50 vs CA-6000
(sec)
120
90
CA-50
60
30 y = 1.087x - 1.293
r = 0.998
0
0 30 60 90 120 (sec)
CA-6000
Method < Instrument > (1) CA-6000

(2) CA-50
Specimens Patient plasma
Comment
Correlation of PT determination on the CA-50 and the CA-6000 using the Thrombrel S in both
instruments. Results were excellent and the correlation was r=0.998 and y=1.087x-1.293.
12
CA-50
4)-2 Correlation - (PT %) using Thromborel S
Results
CA-50 vs CA-6000
(%)
120
90
CA-50
60
30
y = 0.932x + 2.152
r = 0.998
0
0 30 60 90 120 (%)
CA-6000

(2) CA-50
Comment
Correlation of PT activity on the CA-50 and the CA-6000 using the Thrombrel S in both in
struments. Results were excellent and the correlation was r=0.998 and y=0.932x+2.152.
13
CA-50
4)-3 Correlation - (PT sec) using Thromboplastin•C Plus
Results
CA-50 vs CA-6000
(sec)
50
40
30
CA-50
20
y = 1.026x - 0.157
10 r = 0.997
0
0 10 20 30 40 50 (sec)
CA-6000

(2) CA-6000
Comment
Correlation of PT determination on the CA-50 and the CA-6000 using the Thromboplastin•C
Plus in both instruments. Results were excellent and the correlation was r=0.997 and
y=1.026x-0.157.
14
CA-50
4)-4 Correlation - (PT %) using Thromboplastin•C Plus
Results
CA-50 vs CA-6000
(%)
150
100
CA-50
50
y = 0.912x + 3.747
r = 0.997
0
0 50 100 150 (%)
CA-6000

(2) CA-6000
Comment
Correlation of PT activity on the CA-50 and the CA-6000 using the Thromboplastin•C Plus in
both instruments. Results were excellent and the correlation was r=0.997 and y=0.912x+3.747.
15
CA-50
4)-5 Correlation - (PT sec) using Innovin
Results
CA-50 vs CA-6000
(sec)
40
30
CA-50
20
y = 0.896x + 1.236
r = 0.998
10
10 20 30 40 (sec)
CA-6000

(2) CA-50
Comment
Correlation of PT determination on the CA-50 and the CA-6000 using the Innovin in both in
struments. Results were excellent and the correlation was r=0.998 and y=0.896x+1.236.
16
CA-50
4)-6 Correlation - (PT %) using Innovin
Results
CA-50 vs CA-6000
(%)
150
100
CA-50
50
y = 1.106x + 0.503
r = 0.996
0
0 50 100 150 (%)
CA-6000

(2) CA-50
Comment
Correlation of PT determination on the CA-50 and the CA-6000 using the Innovin both instru
ments. Results were excellent and the correlation was r=0.996 and y=1.106x+0.503.
17
CA-50
5)-1 Interference testing - (PT) using Thromborel S
Results
(1) Hemoglobin
Hemoglobin conc. (mg/dL) 0 86 172 258 344 430
Measured value (sec) 12.85 12.70 12.55 12.55 12.55 12.45
Interference (%) - -1.2% -2.3% -2.3% -2.3% -3.1%
(2) Lipid
Lipid conc. (Formazine turbidity unit) 0 566 1,132 1,698 2,264 2,830
Interference (%) - 0.0% -1.6% -0.8% -1.9% -1.9%
(3) Conjugated bilirubin

Conjugated bilirubin cocn. (mg/dL) 0 4.3 8.6 12.9 17.2 21.5
Interference (%) - -0.8% -2.7% -2.7% -4.2% -3.8%
(measured value - measured value without interference)

Interference (%) = x 100
measured value without interference

< Reagents > (1) Thromborel S Lot No. 505453
(2) Interference check A Lot No. 4314
Specimens Pooled plasma
Comment
Interference of Hemoglobin, Lipid and Conjugated bilirubin in the PT measurement was ex
amined. Various concentration of Hemogloin, Lipid and Conjugated bilirubin were added to
the pooled plasma, which was then assayed for PT, using Thromborel S. Hemoglobin made no
influence on PT result up to 430 mg/dL. Lipid made no influence on PT result up to 2,830 For
mazine turbidity unit. Conjugated bilirubin made no influence on PT result up to 21.5 mg/dL.
18
CA-50
5)-2 Interference testing - (PT) using Thromborel S
Results
(1) Hemoglobin
(sec)
16.0
Clotting time
14.0
12.0
10.0
0 100 200 300 400 500 (mg/dL)
Hemoglobin concentration
(2) Lipid
(sec)
16.0
Clotting time
14.0
12.0
10.0
0 1,000 2,000 3,000
Lipid concentration (Formazine turbidity unit)

(sec)
16.0
Clotting time
14.0
12.0
10.0
0 5 10 15 20 25 (mg/dL)
Conjugated bilirubin concentration
19
CA-50
5)-3 Interference testing - (PT) using Thromboplasitn•C Plus
Results
(1) Hemoglobin
Hemoglobin conc. (mg/dL) 0 86 172 258 344 430
Interference (%) - -0.8% -2.1% -2.1% -1.7% -1.7%
(2) Lipid
Lipid conc. (Formazine turbidity unit) 0 566 1,132 1,698 2,264 2,830
Interference (%) - -0.4% -1.2% -1.2% -2.1% -1.6%

Conjugated bilirubin conc. (mg/dL) 0 4.3 8.6 12.9 17.2 21.5
Interference (%) - -0.4% -0.4% -1.2% -1.7% -2.1%
(measured value - without interference measured value)

Interference (%) = x 100
without interference measured value

< Reagents > (1) Thromboplastin•C Plus Lot No. TPC-401
(2) Interference check A Lot No. 7248
Specimens Pooled plasma
Comment
Interference of Hemoglobin, Lipid and Conjugated bilirubin in the PT measurement was ex
amined. Various concentration of HemogloinL, Lipid and Conjugated bilirubin were added to
the pooled plasma, which was then assayed for PT, using Thromboplastin•C Plus. Hemoglobin
made no influence on PT result up to 430 mg/dL. Lipid made no influence on PT result up to
2,830 Formazine turbidity unit. Conjugated bilirubin made no influence on PT result up to 21.5
mg/dL.
20
CA-50
5)-4 Interference testing - (PT) using Thromboplasitn•C Plus
Results
(1) Hemoglobin
(sec)
14.0
Clotting time
13.0
12.0
11.0
10.0
0 100 200 300 400 500 (mg/dL)
Hemoglobin concentration
(2) Lipid
(sec)
14.0
Clotting time
13.0
12.0
11.0
10.0
0 1,000 2,000 3,000
Lipid concentration (Formazine turbidity unit)

(sec)
14.0
Clotting time
13.0
12.0
11.0
10.0
0 5 10 15 20 25 (mg/dL)
Conjugated bilirubin concentration
21
CA-50
6) Difference of results between analysis channels
Results
(1) Ci-Trol Level 1 (2) Ci-Trol Level 2
Ch 1 Ch 2 Ch 3 Ch 4 Ch 1 Ch 2 Ch 3 Ch 4
1 12.2 12.0 12.1 12.1 1 24.2 24.4 24.3 24.5
2 12.0 11.9 12.0 12.0 2 24.3 24.0 24.5 24.0
3 12.0 12.1 11.9 12.0 3 24.5 24.4 24.3 24.2
4 12.1 11.9 11.8 11.9 4 24.6 24.2 24.2 24.6
5 11.9 12.0 11.9 11.8 5 24.6 24.2 24.3 24.0
6 11.8 11.8 11.9 11.8 6 24.4 24.7 24.3 24.0
7 11.9 11.9 11.9 12.0 7 24.5 24.4 24.3 24.2
8 12.2 12.1 12.2 12.1 8 24.1 24.7 24.0 24.1
9 11.8 12.0 12.0 12.0 9 24.3 24.6 24.1 24.4
10 12.1 12.2 12.0 11.9 10 24.1 24.3 24.1 24.3
Mean 12.00 11.99 11.97 11.96 Mean 24.36 24.39 24.24 24.23
SD 0.141 0.114 0.110 0.102 SD 0.180 0.217 0.136 0.205
CV(%) 1.18 0.95 0.92 0.85 CV(%) 0.74 0.89 0.56 0.85
(sec) (sec)
The order of a measurement


Comment
Difference of results between analysis channels was examined on the PT measurement. Ci-Trol
Level 1 (normal range plasma) and Ci-Trol Level 2 (abnormal range plasma) were measured
10 times consecutively each analysis channels (Ch1-4) using Thromboplastin•C Plus.
Results were excellent and showed no difference between analysis channels.
22

Automated Blood Coagulation Analyzer Reproducibility and Standardization Data

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Automated Blood Coagulation Analyzer CA-50

Basic Data Sheet -(PT)

Due to measurement conditions and nature of the speci

1)-1 Reproducibility - (PT) using Thromborel S

Normal Abnormal Control Plasma N Control Plasma P

Mean 10.00 99.52 15.93 48.15 10.76 88.82 20.62 35.03

Method < Instrument > CA-50

1)-2 Reproducibility - (PT) using Thromborel S

Ci-Trol Level 1 Ci-Trol Level 2 Ci-Trol Level 3

sec % sec % sec %

Mean 10.83 87.95 36.39 18.49 60.39 10.45

Method < Instrument > CA-50

Specimens (1) Ci-Trol Level 1 Lot No. COL1-1010

1)-3 Reproducibility - (PT) using Thromboplastin•C Plus

Normal Abnormal Control Plasma N Control Plasma P

Mean 10.32 113.44 13.34 51.63 10.75 100.08 15.42 38.34

Method < Instrument > CA-50

Specimens (1) Normal pooled plasma

1)-4 Reproducibility - (PT) using Thromboplastin•C Plus

Ci-Trol Level 1 Ci-Trol Level 2 Ci-Trol Level 3

sec % sec % sec %

Mean 10.74 100.34 22.12 19.36 30.73 10.40

Method < Instrument > CA-50

Specimens (1) Ci-Trol Level 1 Lot No. COL1-1010

1)-5 Reproducibility - (PT) using Innovin

Normal Abnormal Control Plasma N Control Plasma P

1 12.3 99.7 16.8 47.8 12.6 94.2 21.2 33.4

Method < Instrument > CA-50

Specimens (1) Normal pooled plasma

1)-6 Reproducibility - (PT) using Innovin

Ci-Trol Level 1 Ci-Trol Level 2 Ci-Trol Level 3

sec % sec % sec %

Mean 12.81 90.63 32.05 17.62 49.52 9.00

Method < Instrument > CA-50

2) Day-to-day reproducibility - (PT) using Thromboplastin•C Plus

Method < Instrument > CA-50

Specimens Ci-Trol Level 1 Lot No. COL1-1010

3)-1 Standard Curve - (PT) using Thromborel S

Dilution ratio 1/1 4/5 3/5 2/5 1/5

Method < Instrument > CA-50

Reference Standard Human Plasma Lot No. 502567B

Dilution Owren's veronal buffer

3)-2 Standard Curve - (PT) using Thromboplastin•C Plus

Dilution ratio 1/1 4/5 3/5 2/5 1/5

Method < Instrument > CA-50

Reference Standard Human Plasma Lot No. 502567B

Dilution Owren's veronal buffer

3)-3 Standard Curve - (PT) using Innovin

Dilution ratio 1/1 4/5 3/5 2/5 1/5

Method < Instrument > CA-50

Reference Standard Human Plasma Lot No. 502567B

Dilution Owren's veronal buffer

4)-1 Correlation - (PT sec) using Thromborel S

Method < Instrument > (1) CA-6000

4)-2 Correlation - (PT %) using Thromborel S

Method < Instrument > (1) CA-6000

4)-3 Correlation - (PT sec) using Thromboplastin•C Plus

Method < Instrument > (1) CA-50

Specimens Patient plasma

4)-4 Correlation - (PT %) using Thromboplastin•C Plus

Method < Instrument > (1) CA-50

Specimens Patient plasma

4)-5 Correlation - (PT sec) using Innovin