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Ferritin(FERR)

The performance data of the Ferritin (FERR) Rapid Quantitative Test Kit (FIA)

Manufacturer

SEKBIO

Parameter

Ferritin (FERR) Rapid Quantitative Test Kit (FIA)

Linearity

5~500ng/mL

Detection limit

5ng/mL

Benchmark product

Roche


Standard Curve

Cubic spline interpolation

Concentration
(ng/mL)

0

4.96

8.82

20.14

41.09

90.58

168.31

326.65

548.16

T/C

0.00656

0.19066

0.34919

0.75615

1.32838

2.18875

2.96037

3.89457

4.48854


1 Limit of detection

Result(T/C)

Concentration

0

4.89

1

0.00669

0.17825

2

0.00481

0.16259

3

0.00543

0.21832

4

0.00590

0.20732

5

0.00709

0.17296

6

0.00714

0.21059

7

0.00498

0.19037

8

0.00820

0.16665

9

0.00517

0.18596

10

0.00544

0.17762

11

0.00508

0.16428

12

0.00507

0.21809

13

0.00483

0.16854

14

0.00597

0.18710

15

0.00615

0.20406

16

0.00691

0.21046

17

0.00645

0.19234

18

0.00799

0.18373

19

0.00490

0.21242

20

0.00599

0.21825

AVE

0.00601

0.19150

SD

0.00105

/

AVE+2*SD

0.00811

/

regression equation

y=0.03793x+0.00601

LoB(ng/mL)

0.05529


2 Linear

Cal

Concentration

Result

AVERAGE

S1

4.89

4.72

4.88

4.73

5.18

S2

16.65

18.06

17.04

17.61

15.44

S3

32.54

33.63

32.56

29.97

34.09

S4

106.75

117.29

117.14

125.85

108.27

S5

254.61

242.13

261.02

266.62

274.31

S6

521.65

561.92

576.40

614.44

552.85


13.jpg


3 Accuracy

Cal

concentration

Result

Bias

A1

16.65

15.51

-6.8%

16.83

1.1%

15.36

-7.8%

A2

32.54

35.42

8.8%

33.28

2.3%

34.70

6.6%

A3

106.75

104.95

-1.7%

111.78

4.7%

115.14

7.9%


4 Precision

Cal

Concentration

Cal

Concentration

Cal

Concentration

R1

14.27

R2

37.07

R3

92.08

15.35

34.79

112.46

18.04

36.63

92.16

14.61

30.03

114.26

14.33

35.02

100.89

16.98

30.76

105.09

15.11

36.03

110.16

19.00

32.20

96.13

16.32

34.52

113.71

14.72

28.56

106.52

AVE

15.87

AVE

33.56

AVE

104.35

SD

1.65

SD

2.97

SD

8.62

CV

10.4%

CV

8.9%

CV

8.3%


5 Method Comparison


14.jpg


Sample

Roche

Sekbio

Sample

Roche

Sekbio

1

272.70

265.29

31

113.00

114.43

2

344.22

354.01

32

56.35

62.61

3

45.99

45.87

33

30.52

34.59

4

383.37

323.66

34

471.16

411.77

5

21.30

21.22

35

120.82

118.08

6

20.29

23.50

36

14.98

17.15

7

9.65

10.87

37

92.10

90.21

8

28.73

29.46

38

26.81

28.27

9

63.00

68.49

39

21.06

19.14

10

63.75

67.20

40

36.04

35.20

11

28.14

30.01

41

93.93

82.26

12

22.98

21.45

42

160.76

169.53

13

53.79

66.85

43

11.48

12.79

14

11.62

12.05

44

552.71

447.31

15

109.32

104.49

45

270.49

231.51

16

241.01

246.90

46

23.72

22.19

17

318.27

303.56

47

20.67

21.30

18

189.38

163.71

48

192.95

189.49

19

51.94

47.56

49

30.04

30.18

20

14.04

14.01

50

16.31

15.27

21

116.61

101.45

51

22.16

25.24

22

119.25

129.22

52

395.70

410.76

23

76.07

77.88

53

15.89

14.06

24

24.75

27.80

54

18.84

20.31

25

8.80

8.78

55

421.64

478.75

26

238.85

231.52

56

78.42

81.18

27

49.11

52.01

57

14.32

16.12

28

304.57

262.33

58

31.34

29.19

29

6.16

5.00

59

5.20

5.72

30

37.58

39.25

60

250.94

251.15


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