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Follicle Stimulating Hormone(FSH)

The performance data of the FSH rapid Quantitative Test Kit (FIA)

Manufacturer

SEKBIO

Parameter

FSH

Linearity

0.1~200 mIU/ml

Detection limit

0.1 mIU/ml

benchmark product

Roche

Test principle and procedure

FSH: Add 30 μl of sample + 30 μl of Ra+ 30 μl of Rd incubation for 10 minutes. Wash with 200 μl of washing solution. Finally, add 100 μl of A + 100 μl of B.



Six point calibration test results

Sample Concentration( mIU/ml )

 

RLU

Average

CV

S/N

0.00

270

181

124

192

38.39%

/

5.28

328,441

310,837

325,368

321,549

2.92%

1677.65

45.08

2,734,548

2,761,887

2,619,552

2,705,329

2.79%

14114.76

85.33

4,740,189

4,869,826

4,845,539

4,818,518

1.43%

25140.09

123.20

6,847,928

6,331,928

6,490,393

6,556,750

4.03%

34209.13

208.30

10,343,008

9,995,892

9,948,756

10,095,885

2.13%

52674.18 


Precision

Sample

RLU

Concentration

Sample

RLU

Concentration

 

 

 

 

 

45.08

40.6

2,429,100

 

 

 

 

 

125.54

123.5

6,636,529

45.9

2,732,893

121.6

6,551,933

45.6

2,712,839

123.6

6,644,149

44.4

2,643,743

125.7

6,734,753

44.6

2,654,937

125.7

6,734,422

45.1

2,688,235

126.9

6,790,605

43.2

2,579,281

130.0

6,925,497

46.3

2,752,775

124.8

6,694,353

43.0

2,565,633

133.4

7,077,517

43.0

2,568,870

132.3

7,026,385

AVE

44.17

2,632,830.60

AVE

126.74

6,781,614.30

SD

1.74

98,577.72

SD

3.92

174,162.04

CV

3.9%

3.7%

CV

3.1%

2.6%


1 Limit of detection

Sample

RLU

Concentration

 

 

 

 

Ag Diluent

297

255

0.003

0.003

230

174

0.002

0.002

181

183

0.002

0.003

216

158

0.002

0.002

195

132

0.002

0.000

267

135

0.003

0.000

152

128

0.002

0.000

191

113

0.002

0.000

178

166

0.001

0.002

192

206

0.002

0.002

AVE

210

0.001 

SD

48

0.0005

AVE+2*SD

0.002


2 Linear

Sample( mIU/ml )

Dilution ratio

Concentration value

Average

0.00

0.0

0

0

0

0

41.85

0.2

51.68

51.02

50.81

51

83.69

0.4

95.49

98.25

90.87

95

125.54

0.6

136.10

135.28

135.00

135

167.39

0.8

176.07

177.51

174.82

176

209.24

1.0

206.04

211.97

209.70

209.24 


Linear-1.png

3 Method Comparison

Linear-2.png



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