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.

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