Email

Human Chorionic Gonadotropin (Total HCG β)

The performance data of the Total HCG β Rapid Quantitative Test Kit(CLIA)

Manufacturer

SEKBIO

Parameter

Total HCG β

Linearity

0.500-10000 mIU/mL

Detection limit

0.500 mIU/mL

benchmark product

Beckman

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

247

238

153

213

24.39%

/

5.79

7,950

7,389

7,355

7,565

4.42%

35.57

622.95

722,593

697,041

682,661

700,765

2.89%

3295.13

1258.42

1,259,862

1,240,478

1,358,218

1,286,186

4.91%

6047.90

5998.99

4,834,497

5,537,553

5,042,930

5,138,327

7.03%

24161.41

11406.29

8,165,598

8,137,136

8,081,462

8,128,065

0.53%

38219.74


Precision

Sample

RLU

Concentration

Sample

RLU

Concentration

 

 

 

 

 

685.28

719.1

704,736

 

 

 

 

 

6517.82

6,824

5,365,410

713.3

699,429

6,441

5,110,212

714.1

700,156

6,171

4,928,047

670.0

659,635

6,864

5,391,909

714.0

700,051

6,548

5,182,126

725.7

710,760

6,794

5,345,787

672.4

661,800

6,649

5,249,877

705.7

692,437

6,441

5,110,737

658.4

648,964

6,669

5,262,868

711.4

697,639

6,394

5,078,994

AVE

700.41

687,560.70

AVE

6,579.39

5,202,596.70

SD

23.91

21,977.81

SD

221.16

147,861.12

CV

3.4%

3.2%

CV

3.4%

2.8%


Limit of detection

Sample

RLU

Concentration

 

 

 

 

Ag Diluent

207

114

0.005

0.003

317

144

0.009

0.003

331

127

0.009

0.002

307

146

0.008

0.003

166

170

0.002

0.004

163

155

0.003

0.004

225

179

0.006

0.004

199

99

0.005

0.001

177

157

0.003

0.002

204

184

0.005

0.004

AVE

189

0.051 

SD

64

0.025

AVE+2*SD

0.101


Linear

Sample( mIU/ml )

Dilution ratio

Concentration value

Average

0.00

0.0

0.0

0.0

0.0

0

2275.59

0.2

2,052.0

2,000.3

1,951.4

2,001

4551.18

0.4

4,219.2

4,556.2

4,665.2

4,480

6826.76

0.6

6,836.6

6,895.1

6,780.0

6,837

9102.35

0.8

9,901.1

9,198.6

9,144.3

9,415

11377.94

1.0

11,456.8

11,396.8

11,280.2

11,377.94

 

Human_Chorionic_Gonadotropin-1.png

Method Comparison

Human_Chorionic_Gonadotropin-2.png

Products