Automated Blood Coagulation Analyzer CA-500

Basic Data Sheet -(Fibrinogen)

1) Reproducibility
2) Day-to-day reproducibility
3) Standard Curve, Linearity
4) Correlation
5) Interference testing
 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
using Fibrinogen Determination
1) Reproducibility - (Fbg) Reagent

Results

Patient plasma-1 Patient plasma-2 Patient plasma-3

sec mg/dL sec mg/dL sec mg/dL
1 4.9 461.5 8.2 234.4 18.0 100.2
2 5.0 449.3 8.1 237.5 17.7 102.0
3 4.9 461.5 8.0 240.7 17.3 104.6
4 4.9 461.5 8.3 231.3 18.1 99.6
5 5.0 449.3 8.1 237.5 17.7 102.0
6 5.0 449.3 8.2 234.4 18.0 100.2
7 4.9 461.5 8.0 240.7 18.0 100.2
8 4.9 461.5 8.1 237.5 17.6 102.6
9 4.8 474.5 7.9 243.9 17.6 102.6
10 4.9 461.5 8.0 240.7 18.1 99.6
Mean 4.98 459.14 8.09 237.86 17.81 101.36
SD 0.06 7.89 0.12 3.77 0.27 1.65
CV(%) 1.29 1.72 1.48 1.59 1.51 1.63

Method < Instrument > CA-500

< Reagent > Fibrinogen Determination Reagent
Thrombin Reagent Lot No. TR-470
Specimens Patient plasma (three different levels)

Comment

Three patient plasma at three different levels were measured 10 times consecutively using Fi
brinogen Determination Reagent to test within-run reproducibility. The results were excellent
and the CVs were less than 1.80%.

2
 CA-500
using Fibrinogen Determination
2) Day-to-day reproducibility - (Fbg) Reagent

Results

Pooled plasma (mg/dL)

1 st 2 nd 3 rd 4 th 5 th Total
1 261.5 256.9 261.5 266.2 276.1
2 261.5 256.9 261.5 261.5 266.2
3 271.1 271.1 252.5 266.2 261.5
4 261.5 261.5 261.5 271.1 256.9
5 256.9 271.1 256.9 261.5 271.1
Mean 262.50 263.50 258.78 265.30 266.36 263.29
SD 5.20 7.19 4.04 4.00 7.59 2.936
CV(%) 1.98 2.73 1.56 1.51 2.85 1.12

(mg/dL)
350
Fibrinogen conc.

300

250

200
1 2 3 4 (5 (days)
Time

Method < Instrument > CA-500

< Reagent > Fibrinogen Determination Reagent
Thrombin Reagent Lot No. TR-470
Specimens Pooled plasma

Comments
Pooled plasma was measured for Fibrinogen concentration on 5 consecutive days using Fibrino
gen Determination Reagents to test day-to-day reproducibility.
The coefficient of variation were excellent and 3.0% or less for each plasma.
3
 CA-500

3)-1 Standard Curve - (Fbg) using Fibrinogen Determination

Reagent

Results

Dilution ratio 1/5 1/10 1/20

Fbg Conc. (mg/dL) 488 244 122
Clotting time (sec) 4.7 7.9 15.0

Log Lin

P = a * T+b
r = −0 . 9 9 8
a = −1 . 1 . 1 9 5 e + 0 0
b = 3.3481e+00

Method < Instrument > CA-500

< Reagent > Fibrinogen Determination Reagent Kit
Thrombin Reagent Lot No. TR-470

Specimens Fibrinogen Standard Plasma Lot No. FS-70

Dilution Owren's veronal buffer

Comment
The standard curve of Fbg Concentration was set up, using Fibrinogen Determination Reagents
and Fibrinogen Standard Plasma. Good standard curve was provided with the original plasma
Concentration set at 244mg/dL.

4
 CA-500

3)-2 Linearity - (Fbg) using Fibrinogen Determination Reagent

Results

Fbg mode (1/10 dilution)

Dilution ratio 10/10 9/10 8/10 7/10 6/10 5/10 4/10 3/10 2/10 1/10

Fbg Conc. (mg/dL) 511 535 511 499 412 368 283 208 137 58

+ Fbg mode (1/20 dilution)

Dilution ratio 10/10 9/10 8/10

Fbg Conc. (mg/dL) 736 646 574

(mg/dL)
800
1/10 dilution
Fibrinogen concentration

600 1/20 dilution

400

200

0
10

10

10

10

10

10

10

10

10

0
/1
1/

2/

3/

4/

5/

6/

7/

8/

9/

10

Dilution Ratio

Method < Instrument > CA-500

< Reagent > Fibrinogen Determination Reagent Kit
Thrombin Reagent Lot No. TR-470
Specimens Patient plasma of high concentration fibrinogen

Dilution Owren's veronal buffer

Comment
The Fibrinogen linearity of the measurement results were tested for CA-500 using patient plas
ma of high concentration fibrinogen. Good linearity was observed in the range between 58
and 736 mg/dL.
6
 CA-500

4) Correlation - (Fbg) Using Fibrinogen Determination Reagent

Results

CA-500 vs CA-6000

(mg/dL)
800

600
CA-500

400

n = 67
r = 0.996
200 y = 0.978x + 6.220
x = 277.87
y = 275.00

0
0 200 400 600 800 (mg/dL)
CA-6000

Method < Instrument > (1) CA-500

(2) CA-6000
< Reagent > Fibrinogen Determination Reagent Kit
Thrombin Reagent Lot No.TR-470
Specimens Patient plasma

Comment
Correlation of Fibrinogen concentration on the CA-500 and the CA-6000 using the Fibrinogen
Determination Reagent in both instruments.
Results were excellent and the correlation was r= 0.996 and y=0.978x+6.220.

6
 CA-500

5)-1 Interference testing - (Fbg) using Fibrinogen Determination

Reagent

Results

Lipid concentration (Formazine turbidity unit)

0 380 760 1,140 1,520 1,900
Fbg Conc. (mg/dL) 248.1 248.1 244.0 244.0 237.5 240.7

Hemoglobin concentration (mg/dL)

0 96 192 288 384 480
Fbg Conc. (mg/dL) 240.7 240.7 244.0 240.7 248.1 244.0

Conjugated bilirubin concentration (mg/dL)

0 5.0 10.0 15.0 20.0 25.0
Fbg Conc. (mg/dL) 248.1 244.0 240.7 240.7 244.0 240.7

Unconjugated bilirubin concentration (mg/dL)

0 3.5 7.0 10.4 14.0 17.4

Fbg Conc. (mg/dL) 244.0 237.5 248.1 240.7 231.3 237.5

Method < Instrument > CA-500

< Reagents > (1) Fibrinogen Determination Reagent Kit
Thrombin Reagent Lot No. TR-470
(2) Interference check A Plus Lot No. 6198
Specimens Pooled plasma
Comment
Interference of Lipid, Hemoglobin, Conjugated bilirubin and Unconjugated bilirubin in the Fi
brinogen measurement was examined. Various concentration of Lipid, Hemoglobin, Conjuga
ted bilirubin and Unconjugated bilirubin were added to the pooled plasma, which was then as
sayed for Fbg, using Fibrinogen Determination Reagents. Lipid made no influence on Fbg re
sult up to 1,900 Formazine turbidity unit. Hemoglobin made no influence on Fbg result up to
480 mg/dL. Conjugated bilirubin made no influence on Fbg result up to 25.0 mg/dL. Unconju
gated bilirubin made no influence on Fbg result up to 17.4 mg/dL.

7
 CA-500

5)-2 Interference testing - (Fbg) using Fibrinogen Determination

Reagent

Results

(mg/dL) (1) Lipid

300
280
Fbg conc.

260
240
220
200
0 500 1,000 1,500 2,000
Lipid concentration (Formazine turbidity unit)
(mg/dL) (2) Hemoglobin
300
280
Fbg conc.

260
240
220
200
0 100 200 300 400 500 (mg/dL)
Hemoglobin concentration
(mg/dL) (3) Conjugated bilirubin
300
280
Fbg conc.

260
240
220
200
0 5 10 15 20 25 30 (mg/dL)
Conjugated bilirubin concentration
(mg/dL) (4) Unconjugated bilirubin
300
280
Fbg conc.

260
240
220
200
0 5 10 15 20 (mg/dL)
Unconjugated bilirubin concentration
8