Automated Blood Coagulation Analyzer CA-50

Basic Data Sheet -(Extrinsic Factors)

1) Standard Curve - Factor II

2) Standard Curve - Factor V
3) Standard Curve - Factor VII
4) Standard Curve - Factor X
5) Reproducibility (F.VII)
6) Correlation (F.VII)
 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

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 CA-50

1)-1 Standard Curve - (F.II) using Thromborel S

Results

Dilution ratio 3/2 1/1 1/2 1/4 1/8 1/16

Activity (%) 144.0 96.0 48.0 24.0 12.0 6.0
Clotting time (sec) 21.2 24.7 30.6 39.5 54.2 78.1

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Thromborel S Lot No. 505445
(2) Clotting Factor-II Deficient Plasma Lot No. 500549
Reference Standard Human Plasma Lot No. 502567B
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor II Activity was set up, using Thromborel S and Standard Human
Plasma. Good standard curve was provided with the plasma activity set at 96%.

2
 CA-50

1)-2 Standard Curve - (F.II) using Thromboplastin•C Plus

Results

Dilution ratio 3/2 1/1 1/2 1/4 1/8 1/16

Activity (%) 144.0 96.0 48.0 24.0 12.0 6.0
Clotting time (sec) 17.4 19.4 24.7 31.6 42.8 57.6

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Thromboplastin•C Plus Lot No. 527014
(2) Clotting Factor-II Deficient Plasma Lot No. 500549
Reference Standard Human Plasma Lot No. 502567B
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor II Activity was set up, using Thromboplastin•C Plus and Standard
Hu-man Plasma. Good standard curve was provided with the plasma activity set at 96%.

3
 CA-50

2)-1 Standard Curve - (F.V) using Thromborel S

Results

Dilution ratio 3/2 1/1 1/2 1/4 1/8 1/16

Activity (%) 135.0 90.0 45.0 22.5 11.3 5.6
Clotting time (sec) 23.0 25.8 32.3 40.0 48.4 60.0

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Thromborel S Lot No. 505445
(2) Clotting Factor-V Deficient Plasma Lot No. 503564
Reference Standard Human Plasma Lot No. 502567B
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor V Activity was set up, using Thromborel S and Standard Human
Plasma. Good standard curve was provided with the plasma activity set at 90%.

4
 CA-50

2)-2 Standard Curve - (F.V) using Thromboplastin•C Plus

Results

Dilution ratio 3/2 1/1 1/2 1/4 1/8 1/16

Activity (%) 135.0 90.0 45.0 22.5 11.3 5.6
Clotting time (sec) 17.7 20.3 24.1 28.7 34.5 41.6

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Thromboplastin•C Plus Lot No. 527014
(2) Clotting Factor-V Deficient Plasma Lot No. 503564
Reference Standard Human Plasma Lot No. 502567B
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor V Activity was set up, using Thromboplastin•C Plus and Stan
dard Hu-man Plasma. Good standard curve was provided with the plasma activity set at 90%.

5
 CA-50

3)-1 Standard Curve - (F.VII) using Thromborel S

Results

Dilution ratio 3/2 1/1 1/2 1/4 1/8 1/16

Activity (%) 142.5 95.0 47.5 23.8 11.9 6.0
Clotting time (sec) 23.9 27.3 36.2 45.8 60.9 78.5

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Thromborel S Lot No. 505445
(2) Clotting Factor-VII Deficient Plasma Lot No. 500760
Reference Standard Human Plasma Lot No. 502567B
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor VII Activity was set up, using Thromborel S and Standard Hu
man Plasma. Good standard curve was provided with the plasma activity set at 95%.

6
 CA-50

3)-2 Standard Curve - (F.VII) using Thromboplastin•C Plus

Results

Dilution ratio 3/2 1/1 1/2 1/4 1/8 1/16

Activity (%) 142.5 95.0 47.5 23.8 11.9 6.0
Clotting time (sec) 18.8 21.0 26.1 32.7 41.4 51.1

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Thromboplastin•C Plus Lot No. 527014
(2) Clotting Factor-VII Deficient Plasma Lot No. 500760
Reference Standard Human Plasma Lot No. 502567B
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor VII Activity was set up, using Thromboplastin•C Plus and Stan
dard Hu-man Plasma. Good standard curve was provided with the plasma activity set at 95%.

7
 CA-50

4)-1 Standard Curve - (F.X) using Thromborel S

Results

Dilution ratio 3/2 1/1 1/2 1/4 1/8 1/16

Activity (%) 145.5 97.0 48.5 24.3 12.2 6.1
Clotting time (sec) 24.8 28.3 37.8 51.0 72.3 108.3

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Thromborel S Lot No. 505445
(2) Clotting Factor-X Deficient Plasma Lot No. 504246
Reference Standard Human Plasma Lot No. 502567B
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor X Activity was set up, using Thromborel S and Standard Human
Plasma. Good standard curve was provided with the plasma activity set at 97%.

8
 CA-50

4)-2 Standard Curve - (F.X) using Thromboplastin•C Plus

Results

Dilution ratio 3/2 1/1 1/2 1/4 1/8 1/16

Activity (%) 145.5 97.0 48.5 24.3 12.2 6.1
Clotting time (sec) 19.0 22.0 28.0 36.6 48.5 63.9

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Thromboplastin•C Plus Lot No. 527014
(2) Clotting Factor-X Deficient Plasma Lot No. 504246
Reference Standard Human Plasma Lot No. 502567B
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor X Activity was set up, using Thromboplastin•C Plus and Stan
dard Hu-man Plasma. Good standard curve was provided with the plasma activity set at 97%.

9
 CA-50

5) Reproducibility - (F.VII) using Thromborel S

Results

Control plasma N Control plasma P

sec % sec %
1 24.3 83.3 34.6 24.6
2 24.8 78.2 34.3 25.4
3 24.1 85.5 34.6 24.6
4 24.2 84.4 34.5 24.9
5 24.1 85.5 34.2 25.7
6 24.1 85.5 34.4 25.1
7 24.1 85.5 34.5 24.9
8 24.1 85.5 34.6 24.6
9 23.9 87.8 34.6 24.6
10 24.3 83.3 33.8 26.9

Mean 24.20 84.45 34.41 25.13

SD 0.228 2.418 0.243 0.690
CV(%) 0.94 2.86 0.71 2.75

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Clotting Factor-VII Deficient Plasma Lot No. 500762A
(2) Thromborel S Lot No. 505453

Specimens (1) Control Plasma N Lot No. 502704B

(2) Control Plasma P Lot No. 512645B

Comment

Control Plasma N and Control Plasma P were measured 10 times consecutively using Throm
borel S and Clotting Factor-VII Deficient Plasma to test within-run reproducibility.
Results were excellent and the CVs were less than 3.00%.

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 CA-50

6) Correlation - (F.VII) using Thrombrrel S

Results

CA-50 vs CA-6000

(%)
125

100

75
CA-50

50

25 y = 0.976x - 1.565
r = 0.990

0
0 25 50 75 100 125 (%)
CA-6000

Method < Instrument > (1) CA-6000

(2) CA-50
• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Clotting Factor-VII Deficient Plasma Lot No. 500762A
(2) Thromborel S Lot No. 505453
Specimens Patient plasma
Comment
Correlation of Factor VII activity on the CA-50 and the CA-6000 using the Thrombrel S and
Clotting Factor-VII Deficient Plasma in both instruments.
Results were excellent and the correlation was r=0.990 and y=0.976x-1.565.
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