Automated Blood Coagulation Analyzer CA-500

Basic Data Sheet -(Chromogenic)

1) Reproducibility
1)-1 Antithrombin III
1)-2 Plasminogen
1)-3 α2-Antiplasmin
1)-4 Protein C

2) Standard curve
2)-1 Antithrombin III
2)-2 Plasminogen
2)-3 α2-Antiplasmin
2)-4 Protein C
 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-500

1)-1 Reproducibility - (ATIII)

Results

Control Plasma N Diluted Control Plasma N (1:4)

dOD/min % dOD/min %
1 0.595 88.6 1.019 21.4
2 0.563 93.7 1.015 22.0
3 0.585 90.2 1.008 23.1
4 0.582 90.7 1.028 19.9
5 0.583 90.5 1.020 21.2
6 0.578 91.3 1.021 21.0
7 0.575 91.8 1.020 21.2
8 0.583 90.5 1.025 20.4
9 0.547 96.2 1.012 22.5
10 0.576 91.6 1.023 20.7
Mean 0.5767 91.51 1.0191 21.34
SD 0.0133 2.103 0.0060 0.966
CV(%) 2.30 2.30 0.59 4.53

Method < Instrument > CA-500

< Reagent > Berichrom® Antithrombin III(A) Lot No. 29097

Specimens (1) Control Plasma N Lot No. 502796A

(2) Diluted Control Plasma N (1:4) with Owren's
veronal buffer
Comment

Control Plasma N and diluted Control Plasma N (1:4) with Owren's veronal buffer were meas
ured using Berichrom Antithrombin III(A) 10 times consecutively to test within-run reproduci
bility. The results were excellent and the CVs were less than 5.0%.

2
 CA-500

1)-2 Reproducibility - (PLG)

Results

Control Plasma N Control Plasma P

dOD/min % dOD/min %
1 0.107 103.5 0.027 30.6
2 0.108 104.4 0.028 31.5
3 0.104 100.8 0.028 31.5
4 0.104 100.8 0.029 32.4
5 0.100 97.1 0.029 32.4
6 0.100 97.1 0.028 31.5
7 0.103 99.9 0.028 31.5
8 0.102 98.9 0.028 31.5
9 0.100 97.1 0.029 32.4
10 0.103 99.9 0.027 30.6
Mean 0.1031 99.95 0.0281 31.59
SD 0.0028 2.567 0.0007 0.664
CV(%) 2.72 2.57 2.63 2.10

Method < Instrument > CA-500

< Reagent > Berichrom® Plasminogen Lot No. 541601

Specimens (1) Control Plasma N Lot No. 502796A

(2) Control Plasma P Lot No. 512649

Comment

Control Plasma N and Control Plasma P were measured using Berichrom Plasminogen 10
times consecutively to test within-run reproducibility.
The results were excellent and the CVs were less than 2.8%.

3
 CA-500

1)-3 Reproducibility - (α2-AP)

Results

Control Plasma N Control Plasma P

dOD/min % dOD/min %
1 0.094 93.3 0.140 35.8
2 0.094 93.3 0.141 34.5
3 0.092 95.8 0.141 34.5
4 0.093 94.5 0.142 33.3
5 0.091 97.0 0.141 34.5
6 0.093 94.5 0.143 32.1
7 0.092 95.8 0.140 35.8
8 0.091 97.0 0.142 33.3
9 0.092 95.8 0.141 34.5
10 0.092 95.8 0.142 33.3
Mean 0.0924 95.28 0.1413 34.16
SD 0.001 1.336 0.001 1.169
CV(%) 1.16 1.40 0.67 3.42

Method < Instrument > CA-500

< Reagent > Berichrom® α2-Antiplasmin Lot No. 29097

Specimens (1) Control Plasma N Lot No. 502796A

(2) Control Plasma P Lot No. 512649

Comment

Control Plasma N and Control Plasma P were measured using Berichrom α2-Antiplasmin 10
times consecutively to test within-run reproducibility.
The results were excellent and the CVs were less than 3.50%.

4
 CA-500

1)-4 Reproducibility - (PC)

Results

Control Plasma N Control Plasma P

dOD/min % dOD/min %
1 0.152 104.3 0.051 34.8
2 0.148 101.5 0.049 33.4
3 0.145 99.5 0.053 36.2
4 0.145 99.8 0.051 34.8
5 0.145 99.5 0.051 34.8
6 0.147 100.8 0.053 36.2
7 0.151 103.6 0.054 36.9
8 0.149 102.2 0.054 36.9
9 0.153 105.0 0.053 36.2
10 0.154 105.7 0.053 36.2
Mean 0.1489 102.16 0.0522 35.50
SD 0.0034 2.375 0.0016 1.107
CV(%) 2.31 2.32 3.10 3.12

Method < Instrument > CA-500

< Reagent > Berichrom® Protein C Lot No. 503841

Specimens (1) Control Plasma N Lot No. 502796A

(2) Control Plasma P Lot No. 512649

Comment

Control Plasma N and Control Plasma P were measured using Berichrom Protein C 10 times
consecutively to test within-run reproducibility.
The results were excellent and the CVs were less than 3.20%.

5
 CA-500

2)-1 Standard Curve - (AT-III)

Results

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

Activity (%) 148.5 99.0 49.5 24.8 12.4
dOD/min 0.199 0.540 0.863 1.026 1.077

Lin-Lin

P = a * T+b
r = −0 . 9 9 9
a = −1 . 5 3 2 e + 0 2
b = 1.804e+02

Method < Instrument > CA-500

< Reagent > Berichrom® Antithrombin III(A) Lot No. 29097
Specimens Standard Human Plasma Lot No. 502565A

Dilution Owren's veronal buffer

Comment
The standard curve of Antithrombin III was set up, using Berichrom Antithrombin III(A) and
Standard Human Plasma. Good standard curve was provided with the plasma activity set at
99%.

6
 CA-500

2)-2 Standard Curve - (PLG)

Results

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

Activity (%) 147.0 98.0 49.0 24.5 12.3
dOD/min 0.150 0.108 0.047 0.018 0.007

Lin-Lin

P = a * T+b
r = 0.997
a = 9.155e+02
b = 5.735e+00

Method < Instrument > CA-500

< Reagent > Berichrom® Plasminogen Lot No. 541601
Specimens Standard Human Plasma Lot No. 502565A

Dilution Owren's veronal buffer

Comment
The standard curve of Plasminogen was set up, using Berichrom Plasminogen and Standard
Human Plasma. Good standard curve was provided with the plasma activity set at 98%.

7
 CA-500

2)-3 Standard Curve - (α2-AP)

Results

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

Activity (%) 141.0 94.0 47.0 23.5 11.7
dOD/min 0.058 0.092 0.129 0.150 0.161

Lin-Lin

P = a * T+b
r = −0 . 9 9 9
a = −1 . 2 5 8 e + 0 3
b = 2.119e+02

Method < Instrument > CA-500

< Reagent > Berichrom® α2-Antiplasmin Lot No. 29410
Specimens Standard Human Plasma Lot No. 502565A

Dilution Owren's veronal buffer

Comment
The standard curve of α2-Antiplasmin was set up, using Berichrom α2-Antiplasmin and Stan
dard Human Plasma. Good standard curve was provided with the plasma activity set at 94%.

8
 CA-500

2)-4 Standard Curve - (PC)

Results

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

Activity (%) 99.0 49.5 24.8 12.4 6.2
dOD/min 0.143 0.078 0.036 0.019 0.009

Lin-Lin

P = a * T+b
r = 0.999
a = 6.889e+02
b = −8 . 8 9 8 e − 0 1

Method < Instrument > CA-500

< Reagent > Berichrom® Protein C Lot No. 29097
Specimens Standard Human Plasma Lot No. 502565A

Dilution Owren's veronal buffer

Comment
The standard curve of Protein C was set up, using Berichrom Protein C and Standard Human
Plasma. Good standard curve was provided with the plasma activity set at 99%.