Automated Blood Coagulation Analyzer CA-50

Basic Data Sheet -(Fibrinogen)

1) Reproducibility
2) Day-to-day reproducibility
3) Standard Curve
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

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 CA-50

using Fibrinogen Determination

1) Reproducibility - (Fbg) Reagent

Results

Normal Abnormal
pooled plasma Control plasma N Control plasma P
pooled plasma
sec mg/dL sec mg/dL sec mg/dL sec mg/dL
1 9.5 239.4 19.5 109.4 8.6 266.5 22.8 92.3
2 9.6 236.7 19.1 111.9 8.4 273.3 22.5 93.6
3 9.9 229.0 19.1 111.9 8.5 269.8 22.6 93.1
4 9.6 236.7 19.1 111.9 8.5 269.8 23.0 91.4
5 9.7 234.1 18.8 113.8 8.5 269.8 22.8 92.3
6 9.8 231.5 19.0 112.5 8.4 273.3 22.9 91.8
7 9.5 239.4 19.3 110.6 8.4 273.3 23.4 89.7
8 9.7 234.1 19.3 110.6 8.6 266.5 22.6 93.1
9 9.4 242.1 18.6 115.2 8.4 273.3 23.4 89.7
10 9.8 231.5 19.2 111.3 8.5 269.8 23.2 90.5

Mean 9.65 235.45 19.10 111.91 8.48 270.54 22.92 91.75

SD 0.150 3.937 0.245 1.576 0.075 2.555 0.309 1.333
CV(%) 1.55 1.67 1.28 1.41 0.88 0.94 1.35 1.45

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > Fibrinogen Determination Reagent Kit
Thrombin Reagent Lot No. 527502
Specimens (1) Normal pooled plasma
(2) Abnormal pooled plasma
(3) Control Plasma N Lot No. 502704B
(4) Control Plasma P Lot No. 512645B
Comment
Normal plasma (normal pooled plasma and Control Plasma N) and abnormal plasma (abnormal
pooled plasma and Control Plasma P) were measured 10 times consecutively using Thrombin
Reagent to test within-run reproducibility.
Results were excellent and the CVs were less than 2.00%.

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 CA-50

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

Reagent

Results

1 st 2 nd 3 rd 4 th 5 th Total
1 281.6 285.4 277.9 285.4 274.4
2 277.9 277.9 274.4 281.6 270.9
3 281.6 277.9 274.4 281.6 274.4
4 281.6 277.9 270.9 277.9 277.9
5 285.4 281.6 274.4 277.9 274.4
Mean 281.62 280.14 274.40 280.88 274.40 227.60
SD 2.372 2.995 2.214 2.801 2.214 2.519
CV(%) 0.84 1.07 0.81 1.00 0.81 0.91
(mg/dL)

(mg/dL)
320
Fbg Conc.

300
280
260
240
1 2 3 4 5 (days)
Time

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > Fibrinogen Determination Reagent Kit
Lot No. 527502
Thrombin Reagent
Lot No. COL1-1010
Specimens Ci-Trol Level 1

Comment

Ci-Trol Level 1 (normal rage plasma) was measured for Fibrinogen on 5 consecutive days us
ing Thrombin Reagent to test day-to-day reproducibility.
The results were excellent, and CVs 1.00% or less was achieved for each plasma.

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 CA-50

3) Standard Curve - (Fbg) using Fibrinogen Determination

Reagent

Results

Dilution ratio 1/5 1/10 1/20

Fibrinogen Conc. (mg/dL) 458 229 114.5
Measured Value (sec) 5.2 9.9 18.7

Log.Regress

Log P = a * Log T + b
r = -0.999
a = -1.083E+00
b = 3.437E+00

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > Fibrinogen Determination Reagent Kit
Thrombin Reagent Lot No. 527502

Reference Fibrinogen Standard Plasma Lot No. FSY-33

plasma

Dilution Owren's veronal buffer

Comment
The standard curve of Fibrinogen concentration (mg/dL) was set up, using Thrombin Reagent
and Fibrinogen Standard Plasma. Good standard curve was provided with the plasma Fibrino
gen concentration set at 229 mg/dL.

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 CA-50

4) Correlation - (Fbg) Using Fibrinogen Determination Reagent

Results

CA-50 vs CA-6000

(mg/dL)
600

500

400
CA-50

300

200
y = 0.992x + 8.800
r = 0.994
100

0
0 100 200 300 400 500 600 (mg/dL)
CA-6000

Method < Instrument > (1) CA-6000

(2) CA-50
• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > Fibrinogen Determination Reagent Kit
Thrombin Reagent Lot No. 527502
Specimens Patient plasma

Comment
Correlation of Fibrinogen determination on the CA-50 and the CA-6000 using the Fibrinogen
Determination Reagent in both instruments.
Results were excellent and the correlation was r=0.994 and y=0.992x+8.800.
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 CA-50

5)-1 Interference testing - (Fbg) Using Fibrinogen

Determination Reagent

Results

(1) Hemoglobin
Hemoglobin conc. (mg/dL) 0 86 172 258 344 430
Measured value (sec) 224.07 217.05 220.51 210.35 220.51 221.69
Interference (%) - -2.9% -1.5% -2.0% -1.5% -1.0%
(2) Lipid
Lipid conc. (Formazine turbidity unit) 0 566 1,132 1,698 2,264 2,830
Measured value (sec) 215.93 221.51 221.69 220.51 226.51 224.07
Interference (%) - 1.9% 2.4% 1.9% 4.3% 3.3%
(3) Conjugated bilirubin
Conjugated bilirubin conc. (mg/dL) 0 4.3 8.6 12.9 17.2 21.5
Measured value (sec) 219.35 221.69 222.87 220.51 225.29 224.07
Interference (%) - 1.0% 1.4% 0.5% 2.4% 1.9%

(measured value - without interference measured value)

Interference (%) = x 100
without interference measured value

Method < Instrument > CA-50

• Pipette : Eppendorf reference 4910 (50-200 µL)
• Chip : Eppendorf 300 µL chip
< Reagents > Fibrinogen Determination Reagent Kit
Thrombin Reagent Lot No. 527502
Specimens Pooled plasma

Comment
Interference of Hemoglobin, Lipid and Conjugated bilirubin in the PT measurement was ex
amined. Various concentration of HemogloinL, Lipid and Conjugated bilirubin were added to
the pooled plasma, which was then assayed for Fibrinogen determination, using Thrombin Re
agent. Hemoglobin made no influence on Fbg result up to 430 mg/dL. Lipid made no influence
on Fbg result up to 2,830 Formazine turbidity unit. Conjugated bilirubin made no influence on
Fbg result up to 21.5 mg/dL.

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 CA-50

5)-2 Interference testing - (Fbg) Using Fibrinogen

Determination Reagent

Results

(1) Hemoglobin
(sec)
300
Fibrinogen conc.

250

200

150
0 100 200 300 400 500 (mg/dL)
Hemoglobin concentration

(2) Lipid
(sec)
300
Fibrinogen conc.

250

200

150
0 1,000 2,000 3,000
Lipid concentration (Formazine turbidity unit)

(3) Conjugated bilirubin

(sec)
300
Fibrinogen conc.

250

200

150
0 5 10 15 20 25 (mg/dL)
Conjugated bilirubin concentration