Automated Blood Coagulation Analyzer CA-500

Basic Data Sheet -(Thrombin Time)

1) Reproducibility
2) Correlation
3) Heparin sensitivity
4) Fibrinogen sensitivity
 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) Reproducibility - (TT)

Results

Reconstitution in normal volume Reconstitution in half normal volume

Control Plasma N Control Plasma P Control Plasma N Control Plasma P
1 17.8 22.2 12.0 16.6
2 18.0 21.9 11.8 15.8
3 17.7 22.9 11.9 16.1
4 18.1 25.1 12.0 15.9
5 18.4 22.7 12.2 15.7
6 17.9 23.1 12.0 15.7
7 17.9 22.2 12.6 16.3
8 18.6 22.8 11.9 16.6
9 17.1 21.6 12.4 15.1
10 17.8 22.4 12.1 16.9
Mean 17.93 22.69 12.09 16.07
SD 0.406 0.967 0.247 0.540
CV(%) 2.26 4.26 2.04 3.36
(sec)

Method < Instrument > CA-500

< Reagents > Test Thrombin Reagent
(1) Reconstitution in normal volume
(2) Reconstitution in half normal volume Lot No. 515451

Specimens (1) Control plasma N Lot No. 502707

(2) Control plasma P Lot No. 512647A

Comment

Control plasma N and Control P were measured 10 times consecutively using Test Thrombin
Reagent to test within-run reproducibility. The results were excellent and the CVs were less
than 4.50%.

2
 CA-500

2)-1 Correlation - (TT)

Results

CA-500 vs CA-6000

(sec)
50

40
CA-500

30

20 n = 26
r = 0.973
y = 0.758x + 5.53

10
10 20 30 40 50 (sec)
CA-6000

Method < Instrument > (1) CA-500

(2) CA-6000
< Reagent > Test Thrombin Reagent (1/1) Lot No. 515451

Specimens Patient plasma

Comment
Correlation of Thrombin Time on the CA-500 and the CA-6000 using Test Thrombin Reagent
in both instruments.
Results were good and the correlation was r=0.973 and y=0.758x+5.53.

3
 CA-500

2)-2 Correlation - (TT)

Results

CA-500 vs CA-7000

(sec)
50

40
CA-500

30

20 n = 26
r = 0.975
y = 0.793x + 5.039

10
10 20 30 40 50 (sec)
CA-7000

Method < Instrument > (1) CA-500

(2) CA-7000
< Reagents > Test Thrombin Reagent (1/1) Lot No. 515451

Specimens Patient plasma

Comment
Correlation of Thrombin Time on the CA-500 and the CA-7000 using Test Thrombin Reagent
in both instruments.
Results were good and the correlation was r=0.975 and y=0.793x+5.039.

4
 CA-500

2)-3 Correlation - (TT)

Results

CA-500 vs CA-1500

(sec)
50

40
CA-500

30

20 n = 26
r = 0.957
y = 1.040x + 0.064

10
10 20 30 40 50 (sec)
CA-1500

Method < Instrument > (1) CA-500

(2) CA-1500
< Reagents > Test Thrombin Reagent (1/1) Lot No. 515451

Specimens Patient plasma

Comment
Correlation of Thrombin Time on the CA-500 and the CA-1500 using Test Thrombin Reagent
in both instruments.
Results were good and the correlation was r=0.957 and y=1.040x+0.064.

5
 CA-500

2)-4 Correlation - (TT)

Results

CA-500 vs CA-50

(sec)
50

40
CA-1500

30

20 n = 26
r = 0.979
y = 0.903x + 2.520

10
10 20 30 40 50 (sec)
CA-50

Method < Instrument > CA-500

CA-50
• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > Test Thrombin Reagent (1/1) Lot No. 515451

Specimens Patient plasma

Comment
Correlation of Thrombin Time on the CA-500 and the CA-50 using Test Thrombin Reagent in
both instruments.
Results were good and the correlation was r=0.979 and y=0.903x+2.520.

6
 CA-500

3)-1 Heparin sensitivity - (TT)

Results

Reconstitution in Heparin concentration (unit/mL)

normal volume 0.0 0.10 0.15 0.20 0.30 0.40

Measured value (sec) 17.8 19.7 22.9 26.1 41.0 80.2

Reconstitution in half Heparin concentration (unit/mL)

normal volume 0.0 0.10 0.15 0.20 0.30 0.40

Measured value (sec) 12.5 14.4 15.3 18.5 30.4 67.3

Method < Instrument > CA-500

< Reagents > Test Thrombin Reagent Lot No. 515451
(1) Reconstitution in normal volume
(2) Reconstitution in half normal volume
Specimens Pooled plasma

Comment
Heparin was added to pooled plasma, and the heparin sensitivity on the Thrombin Time (TT)
result was examined. The reference interval was 14-21 seconds at reconstitution in normal vol
ume and 8-13 seconds at reconstitution in half normal volume.
As a result, up to 0.10 units/mL heparin at reconstitution in normal volume made no influence
on TT results. In heparin at reconstitution in half normal volume, it was influence by 0.10
units/mL heparin.

7
 CA-500

3)-2 Heparin sensitivity - (TT)

Results

(1) Reconstitution in normal volume

(sec)
100

80
Clotting time

60

40

20 reference interval
14 - 21 seconds

0 0.1 0.2 0.3 0.4 (units/ml)

Heparin concentration

(2) Reconstitution in half normal volume

(sec)
80

60
Clotting time

40

20
reference interval
8 - 13 seconds
0

0 0.1 0.2 0.3 0.4 (units/ml)

Heparin concentration
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 CA-500

4) Fibrinogen sensitivity - (TT)

Results

Fibrinogen concentration (mg/dl) 52 83 93 141 192 266

Measured value (sec) *** 38.4 31.4 22.7 18.1 17.4

Fibrinogen concentration (mg/dl) 373 592 812 1049 1140 1539

Measured value (sec) 18.3 21.0 19.5 23.9 23.9 29.5

(sec)
60

50
Clotting Time

40

30

20 reference interval
14 - 21 seconds
10

0 400 800 1200 1600 (mg/dl)

Fibrinogen Concentration

Method < Instrument > CA-500

< Reagents > Test Thrombin Reagent (1/1) Lot No. 515451

Specimens Pooled plasma

Comment
The fibrinogen sensitivity on the TT was examined. Low-concentration fibrinogen sample with
depleted fibrinogen and high-concentration sample with added fibrinogen were prepared.
These two samples were mixed to prepare a series of samples with various fibrinogen concen
tration. Fibrinogen concentration exceeding the reference interval(14-21 seconds) was ob
served at 141mg or less and 812mg or more.