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INS(Insulin)

The performance data of the INS Rapid Quantitative Test Kit(CLIA)

Manufacturer

SEKBIO

Parameter

INS

Linearity

0.2-1000uIU/mL

Detection limit

0.01uIU/mL

benchmark product

Roche

Test principle and procedure

INS: Add 10 μl of sample + 30 μl of Ra, incubation for 10 minutes with cleaning, 30 μl of Rd incubation for 5 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( uIU/ml)

RLU

Average

CV

S/N

1,014.31

1,172,979

1,050,097

1,151,211

1,124,762

5.83%

962.43

200.09

204,519

236,269

200,489

213,759

9.17%

182.91

20.85

20,916

21,322

23,821

22,020

7.14%

18.84

1.95

3,033

2,775

3,191

3,000

7.00%

2.57

0.22

1,485

1,460

1,402

1,449

2.94%

1.24

0.02

1,124

1,158

1,224

1,169

4.35%

1.00


Precision

Sample

RLU

Concentration

Sample

RLU

Concentration






0.25

3,048

2.00






15.21

196,412

184.18

3,002

1.96

216,766

202.86

3,076

2.03

221,674

207.36

3,191

2.15

225,286

210.67

3,057

1.98

206,126

193.10

3,053

2.01

195,386

183.24

3,245

2.21

190,951

179.16

3,269

2.24

226,027

211.35

3,064

2.02

226,762

212.02

3,409

2.38

210,788

197.38

AVE

3,141

2.10

AVE

211,618

198.13

SD

131.00

0.14

SD

13760.15

12.63

CV

4.17%

6.67%

CV

6.50%

6.37%


Limit of detection

Sample

RLU

Concentration





Ag Diluent

1,222

1,206

0.07

0.06

1,231

1,267

0.08

0.09

1,273

1,117

0.13

0.03

1,270

1,171

0.09

0.03

1,110

1,134

0.03

0.03

1,141

1,331

0.03

0.19

1,161

1,176

0.00

0.04

1,223

1,279

0.07

0.13

1,129

1,123

0.03

0.03

1,171

1,262

0.04

0.14

AVE

1,200

0.07

SD

65.51

0.05

AVE+2*SD

0.164


Linear

Sample(uIU/ml)

Dilution ratio

Concentration value

Average

1014.31

1.0

1056.80

948.51

1037.63

1014.31

811.49

0.8

767.04

753.74

760.49

760.42

608.67

0.6

552.77

518.70

582.22

551.23

405.86

0.4

342.35

381.00

354.64

359.33

203.04

0.2

224.90

194.47

199.70

206.36

0.22

0.0

0.24

0.22

0.21

0.22


9.jpg


Method Comparison

10.jpg



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