HCV在检测中的应用-技术专题
2019-08-23 11:27:48
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.