Automated Blood Coagulation Analyzer CA-50

Basic Data Sheet -(Intrinsic Factors)

1) Standard Curve - Factor VIII

2) Standard Curve - Factor IX
3) Standard Curve - Factor XI
4) Standard Curve - Factor XII
5) Reproducibility (F.VIII)
6) Correlation (F.VIII)
 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 Standard Curve - (F.VIII) using Pathromtin SL

Results

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

Activity (%) 138.0 92.0 46.0 23.0 11.5 5.8
Clotting time (sec) 63.7 68.9 78.8 88.6 101.1 112.5

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Pathromtin SL Lot No. 523737
(2) Clotting Factor-VIII Deficient Plasma Lot No. 503841B
(3) Calcium Chloride- 0.025mol/L Lot No. 506871
Reference Standard Human Plasma Lot No. 502566
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor VIII Activity was set up, using Pathromtin SL and Standard Hu
man Plasma. Good standard curve was provided with the plasma activity set at 92%.

2
 CA-50

1)-2 Standard Curve - (F.VIII) using ACTIN

Results

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

Activity (%) 138.0 92.0 46.0 23.0 11.5 5.8
Clotting time (sec) 52.8 57.8 68.1 76.5 85.8 96.0

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) ACTIN Lot No. APAC-806
(2) Clotting Factor-VIII Deficient Plasma Lot No. 503841B
(3) Calcium Chloride- 0.025mol/L Lot No. 506871
Reference Standard Human Plasma Lot No. 502566
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor VIII Activity was set up, using ACTIN and Standard Hu-man
Plasma. Good standard curve was provided with the plasma activity set at 92%.

3
 CA-50

2)-1 Standard Curve - (F.IX) using Pathromtin SL

Results

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

Activity (%) 150.0 100.0 50.0 25.0 12.5 6.3
Clotting time (sec) 58.0 62.9 72.4 82.0 93.9 106.1

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Pathromtin SL Lot No. 523737
(2) Clotting Factor-IX Deficient Plasma Lot No. 500855
(3) Calcium Chloride- 0.025mol/L Lot No. 506871
Reference Standard Human Plasma Lot No. 502566
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor IX Activity was set up, using Pathromtin SL and Standard Hu
man Plasma. Good standard curve was provided with the plasma activity set at 100%.

4
 CA-50

2)-2 Standard Curve - (F.IX) using ACTIN

Results

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

Activity (%) 150.0 100.0 50.0 25.0 12.5 6.3
Clotting time (sec) 50.1 54.9 62.4 72.5 81.0 92.8

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) ACTIN Lot No. APAC-806
(2) Clotting Factor-IX Deficient Plasma Lot No. 500855
(3) Calcium Chloride- 0.025mol/L Lot No. 506871
Reference Standard Human Plasma Lot No. 502566
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor IX Activity was set up, using ACTIN and Standard Hu-man Plas
ma. Good standard curve was provided with the plasma activity set at 100%.

5
 CA-50

3)-1 Standard Curve - (F.XI) using Pathromtin SL

Results

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

Activity (%) 139.5 93.0 46.5 23.3 11.7 5.9
Clotting time (sec) 75.5 82.6 94.4 106.9 121.8 135.0

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Pathromtin SL Lot No. 523737
(2) Clotting Factor-XI Deficient Plasma Lot No. 500343
(3) Calcium Chloride- 0.025mol/L Lot No. 506871
Reference Standard Human Plasma Lot No. 502566
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor XI Activity was set up, using Pathromtin SL and Standard Hu
man Plasma. Good standard curve was provided with the plasma activity set at 93%.

6
 CA-50

3)-2 Standard Curve - (F.XI) using ACTIN

Results

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

Activity (%) 139.5 93.0 46.5 23.3 11.7 5.9
Clotting time (sec) 64.0 70.2 81.4 92.4 105.4 116.8

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) ACTIN Lot No. APAC-806
(2) Clotting Factor-XI Deficient Plasma Lot No. 500343
(3) Calcium Chloride- 0.025mol/L Lot No. 506871
Reference Standard Human Plasma Lot No. 502566
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor XI Activity was set up, using ACTIN and Standard Hu-man Plas
ma. Good standard curve was provided with the plasma activity set at 93%.

7
 CA-50

4)-1 Standard Curve - (F.XII) using Pathromtin SL

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) 57.6 63.1 81.5 119.7 182.6 262.6

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Pathromtin SL Lot No. 523737
(2) Clotting Factor-XII Deficient Plasma Lot No. 500441
(3) Calcium Chloride- 0.025mol/L Lot No. 506871
Reference Standard Human Plasma Lot No. 502566
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor XII Activity was set up, using Pathromtin SL and Standard Hu
man Plasma. Good standard curve was provided with the plasma activity set at 96%.

8
 CA-50

4)-2 Standard Curve - (F.XII) using ACTIN

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) 53.8 60.4 81.7 106.0 148.6 217.1

Log.Pt.Pt

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) ACTIN Lot No. APAC-806
(2) Clotting Factor-XII Deficient Plasma Lot No. 500441
(3) Calcium Chloride- 0.025mol/L Lot No. 506871
Reference Standard Human Plasma Lot No. 502566
plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Factor XII Activity was set up, using ACTIN and Standard Hu-man
Plasma. Good standard curve was provided with the plasma activity set at 92%.

9
 CA-50

5) Reproducibility - (F.VIII) using Pathromtin SL

Results

Control plasma N Control plasma P

sec % sec %
1 64.1 96.9 84.7 23.2
2 64.9 91.1 85.9 21.5
3 64.7 92.5 85.3 22.4
4 65.7 85.7 85.3 22.4
5 65.5 87.0 85.1 22.6
6 64.9 91.1 85.9 21.5
7 65.1 89.7 85.5 22.1
8 64.5 93.9 83.7 24.7
9 64.9 91.1 85.7 21.8
10 64.7 92.5 85.9 21.5

Mean 64.90 91.15 85.30 22.37

SD 0.438 3.055 0.651 0.940
CV(%) 0.68 3.35 0.76 4.20

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > (1) Clotting Factor-VIII Deficient Plasma Lot No. 503833A
(2) Pathromtin SL Lot No. 523733A
(3) Calcium Chloride - 0.025mol/L Lot No. 506806
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 Pathrom
tin SL, Clotting Factor-VIII Deficient Plasma and Calcium Chloride - 0.025mol/L to test with
in-run reproducibility.
Results were excellent and the CVs were less than 5.00%.

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 CA-50

6) Correlation - (F.VIII) using Pathromtin SL

Results

CA-50 vs CA-6000

(%)
200

150
CA-50

100

50
y = 0.987x + 0.042
r = 0.960

0
0 50 100 150 200 (%)
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-VIII Deficient Plasma
(2) Pathromtin SL Lot No. 500762A
(2) Calcium Chloride - 0.025mol/L Lot No. 505453
Lot No. 506806
Specimens Patient plasma
Comment
Correlation of Factor VIII activity on the CA-50 and the CA-6000 using the Pathromtin, Clot
ting Factor-VIII Deficient Plasma and Calcium Chloride - 0.025mol/L in both instruments.
Results were excellent and the correlation was r=0.960 and y=0.987x+0.042.
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