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HCV在检测中的应用-技术专题

2019-08-23 11:27:48

厦门万渤生物HCV附件一(产品).docx


1 HCV抗原说明

1.1包含HCV core/NS3/NS4抗原活性片段,其中NS3片段为全长表达。

1.2为可溶性表达抗原,保持抗原的天然构像。

1.3用亲和层析纯化,抗原纯度大于95%,MW为53KD,无融合蛋白。

1.4对美国BBI Seroconversion Panel PHV909/910/917/920,欧盟 ZeptoMetrix PanelHCV9058的检测结果均优于ORTHO产品。

1.5适用于固相包被,磁珠共价偶联,荧光微球共价偶联及其他应用。

 

2 美国BBI Seroconversion Panel PHV909/910/917/921,HCV9058的检测结果

BBI Panel

Hepatitis C Seroconversion Panel (PHV909)

HCV Genotype 3




Anti-HCV EIA Test

Ortho Anti-HCV RIBA 2.0

Direct Sandwich

Member

Bleed

Days Since

Abbott 2.0

Ortho 3.0

5--1-1

C100-3

C33C

C22-3


WinBio

 ID#

Dates

1st Bleed

s/co

s/co

NS4

NS4

NS3

CORE

Result

OD

s/co

PHV909-01

18-Jan-96

0

0.3

0

-

-

-

(+ / -)

NEG

0.022

0.16

PHV909-02

14-Feb-96

28

1.9

1.4

-

-

-

2+

IND

0.541

3.84

PHV909-03

17-Feb-96

30

1.8

1.4

-

-

-

2+

IND

0.866

6.14

 

 

 

BBI Panel

Hepatitis C Seroconversion Panel (PHV910)

HCV Genotype 1b




Anti-HCV EIA Test

Ortho Anti-HCV RIBA 2.0

Direct Sandwich

Member

Bleed

Days Since

Abbott 2.0

Ortho 3.0

5--1-1

C100-3

C33C

C22-3


WinBio

 ID#

Dates

1st Bleed

s/co

s/co

NS4

NS4

NS3

CORE

Result

OD

s/co

PHV910-01

26-Aug-96

0

0.2

0

-

-

-

-

NEG

0.028

0.20

PHV910-02

30-Aug-96

4

0.3

0

-

-

-

-

NEG

0.053

0.38

PHV910-03

3-Sep-96

8

1.3

2.1

-

-

-

2+

IND

1.509

10.70

PHV910-04

6-Sep-96

11

2.9

>5

-

-

-

3+

IND

2.63

18.65

PHV910-05

10-Sep-96

15

3.4

>5

-

-

(+/-)

3+

IND

2.557

18.13

 

BBI Panel

Anti-HCV Seroconversion Panel (PHV917)

HCV Genotype 2b




Anti-HCV  EIA Test

Ortho Anti-HCV RIBA 3.0

Direct Sandwich

Member

Bleed

Days Since

Abbott 2.0

Ortho 3.0

c100(p)

c33c

c22(p)

NS5


WinBio

 ID#

Dates

1st Bleed

s/co

s/co

NS4

NS3

CORE

NS5

Result

OD

s/co

PHV917-01

29-May-96

0

0.2

0

-

-

-

-

NEG

0.016

0.11

PHV917-02

11-Jun-96

13

0.2

0

-

-

-

-

NEG

0.019

0.13

PHV917-03

18-Jun-96

20

0.2

0

-

-

-

-

NEG

0.017

0.12

PHV917-04

20-Jun-96

22

0.1

0

-

-

-

-

NEG

0.017

0.12

PHV917-05

22-Aug-96

85

0.8

>4.7

-

4+

2+

-

POS

2.152

15.26

PHV917-06

7-Oct-96

131

0.8

>4.7

-

4+

2+

-

POS

3.089

21.91

PHV917-07

11-Oct-96

135

1

>4.7

-

4+

2+

-

POS

3.329

23.61

PHV917-08

14-Oct-96

138

1.2

>4.7

-

4+

2+

-

POS

3.444

24.43

PHV917-09

22-Oct-96

146

3.6

>4.7

(+/-)

4+

2+

-

POS

3.664

25.99

PHV917-10

28-Oct-96

152

3.9

>4.7

1+

4+

2+

-

POS

3.523

24.99

 

BBI Panel

Hepatitis C Seroconversion Panel (PHV920)

HCV Genotype 1a




Anti-HCV EIA Test

Ortho Anti-HCV RIBA 3.0

Direct Sandwich

Member

Bleed

Days Since

Abbott 2.0

Ortho 3.0

c100(p)

c33c

c22(p)

NS5


WinBio

 ID#

Dates

1st Bleed

s/co

s/co

NS4

NS3

CORE

NS5

Result

OD

s/co

PHV 920-01

1-Dec-99

0

0.4

0

-

-

-

-

NEG

0.009

0.06

PHV 920-02

6-Dec-99

5

0.6

0

-

-

-

-

NEG

0.014

0.10

PHV 920-03

8-Dec-99

7

1

0

-

-

-

-

NEG

0.037

0.26

PHV 920-04

14-Dec-99

13

1.8

0.5

-

1+

(+/-)

-

IND

1.198

8.50

PHV 920-05

17-Dec-99

16

2.9

3.1

-

3+

1+

-

POS

1.487

10.55

PHV 920-06

21-Dec-99

20

3.4

3.6

-

3+

1+

-

POS

0.508

3.60

PHV 920-07

27-Dec-99

26

3.4

>5.0

-

3+

1+

-

POS

0.404

2.87

PHV 920-08

29-Dec-99

28

3.7

>5.0

-

4+

2+

1+

POS

0.539

3.82

PHV 920-09

3-Jan-00

33

>4.4

>5.0

1+

4+

2+

3+

POS

1.166

8.27

PHV 920-10

5-Jan-00

35

>4.4

>5.0

1+

4+

3+

3+

POS

1.233

8.74

 

 

SeraCare Panel

Hepatitis C ZeptoMetrix Panel (HCV9058)

HCV Genotype 1a



Anti-HCV EIA Test



Direct Sandwich

other

Member

Days Since

Abbott 2.0

Ortho 3.0

Roche

RIBA

HCV RBA

WinBio


 ID#

1st Bleed

s/co

s/co

s/co


拷贝/ml

OD

S/CO

OD

S/CO

HCV 9058-1

0

0.15

0.14

0.29

NEG

POS

0.042

0.3

0.000

0.00

HCV 9058-2

3

0.19

0.2

1.47

NEG

POS

0.056

0.41

0.000

0.00

HCV 9058-3

7

0.55

0.5

23.6

NEG

POS

0.193

1.4

0.000

0.00

HCV 9058-4

10

1.63

0.99

88.04

POS

POS

0.703

5.09

0.000

0.00

HCV 9058-5

14

5.13

5.18

193

POS

POS

1.442

10.3

0.001

0.01

注:other为国内某知名厂家的HCV夹心法试剂

 

 

 

 

3 酶免平台:两步法

N1

0.047

P1

3.275

L1

2.783

N2

0.044

P2

3.356

L2

2.784

N3

0.051

P3

3.364

L3

2.199

N4

0.042

P4

2.965

L4

0.291

N5

0.047

P5

3.356

LJ

3.275

N6

0.075

P6

3.256

1NCU

2.571

N7

0.048

P7

3.286



N8

0.044

P8

2.927



N9

0.089

P9

2.225



N10

0.066

P10

3.245



N11

0.047

P11

3.286



N12

0.045

P12

3.354



N13

0.049

P13

3.256



N14

0.035

P14

3.322



N15

0.041

P15

3.265



N16

0.041

P16

3.364



N17

0.12

P17

3.335



N18

0.04

P18

3.363



N19

0.04

P19

3.245



N20

0.05

P20

2.209



N21

0.048

P21

3.024



N22

0.04

P22

3.052



N23

0.063

P23

2.063



N24

0.044

P24

2.742



N25

0.052

P25

3.285



N26

0.061

P26

3.312



N27

0.037

P27

2.449



N28

0.038

P28

2.698



N29

0.044

P29

2.785



N30

0.046

P30

3.259



 

 

 

 

 

 

 

4 胶体金平台测试临检中心的2NCU






以上数据及图片资料来源于北京铂莱瑞生物技术有限公司顾竞飞老师

5 客户反馈

某知名胶体金生产厂商用我们的抗原成功通过CE marker,试剂性能一次性通过,认证时间因而提前了两个月,出于保密原则不便提供测试数据。

 

 

 

6 相关文献

[1] 郑嘉庚,程缤雁.丙型肝炎病毒抗体胶体金免疫层析法的建立[J].标记免疫分析与临床,2018年05期

[2] Rui-Feng Yang,Yan Liu1, Cai-Yan Zhao,Ya-Xing Ding,Yu Chen,Ya-Dong Wang,Zhong-Ping Duan.A novel point-of-care oral anti-HCV assay: Is it reliable for screening hepatitis C virus

infection in the era of direct-acting antivirals? [J]. PLoS ONE 14(2): e0211795.