制造商 |
产品名称 |
方法 |
灵敏度(均值) % (1) |
特异性% (2) [181份阴性血清盘 |
特异性% (3) [200份阴性血清盘 |
北京万泰生物药业 |
HCV ELISA Anti-HCV Antibody ELISA Kit |
ELISA |
100.00 |
100.00 |
100.00 |
北京金伟凯医学生物技术有限公司 |
Anti-HCV Ab EIA Kit |
ELISA |
100.00 |
100.00 |
99.00 |
北京金豪制药有限公司 |
Diagnostic Kit for Antibody to Hepatitis C Virus (ELISA) |
ELISA |
99.50 |
100.00 |
100.00 |
艾康生物技术 |
Acon HCV |
Rapid |
under evaluation |
under evaluation |
under evaluation |
北京华大吉比爱生物技术有限公司 |
Diagnostic Kit for Antibody to Hepatitis C Virus (ELISA) |
ELISA |
100.00 |
100.00 |
99.50 |
英科新创(厦门)科技有限公司 |
HCV ELISA Test Kit |
ELISA |
100.00 |
97.79 |
96.50 |
郑州博赛生物工程有限责任公司 |
Anti-HCV Antibody ELISA Kit |
ELISA |
99.50 |
99.45 |
98.00 |
上海飞龙医用诊断用品有限公司 |
Diagnostic Kit for Antibody to Hepatitis C Virus (ELISA) |
ELISA |
100.00 |
100.00 |
98.50 |
上海复兴长征有限公司 |
Diagnostic Kit for Antibody to Hepatitis C Virus (ELISA) |
ELISA |
99.00 |
98.90 |
97.00 |
上海荣盛生物技术有限公司 |
QuickNow Anti-HCV Diagnostic Kit (ELISA) |
ELISA |
100.00 |
98.34 |
96.50 |
上海科华生物技术有限公司 |
Diagnostic Kit for Antibody to Hepatitis C Virus (ELISA) |
ELISA |
100.00 |
100.00 |
99.00 |
华美生物工程公司 |
Diagnostic Kit for Antibody to Hepatitis C Virus (ELISA) |
ELISA |
100.00 |
100.00 |
98.50 |
普生( 天津)科技有限公司GBT |
Anti-HCV EIA-96 |
ELISA |
99.50 |
99.45 |
99.50 |
中山生物工程有限公司 |
HCV IgG ELISA Kit |
ELISA |
100.00 |
99.45 |
97.50 |
雅培 Co. & KG (4) |
雅培 HCV 3.0 |
ELISA |
100.00 |
100.00 |
96.00 |
强生 Clinical Diagnostics, Inc. (4) |
Vitros Anti-HCV |
ELISA |
100.00 |
100.00 |
97.50 |
雅培 Co & KG (4) |
雅培 Architect Anti-HCV |
ELISA |
100.00 |
99.45 |
98.50 |
GreenCross Life Science Corp.(韩国) |
GENEDIA HCV Rapid |
Rapid |
96.50 |
99.45 |
96.50 |
GreenCross Life Science Corp.(韩国) |
GENEDIA HCV ELISA 3.0 |
ELISA |
99.00 |
100.00 |
100.00 |
GreenCross Life Science Corp.(韩国) |
GENEDIA HCV Rapid LF |
Rapid |
86.00 |
98.90 |
99.00 |
IMBIO(俄罗斯) |
Anti-HCV ELISA |
ELISA |
99.50 |
100.00 |
99.50 |
Institut Pastera Sankt- Petersburg |
Anti-HCV ELISA-G |
ELISA |
100.00 |
N/A |
N/A |
J. Mitra & Co. Ltd. |
HCV Microlisa |
ELISA |
94.00 |
100.00 |
99.50 |
Bhat Bio-Tech India (P) Ltd.(印度)
|
Hepa-Scan Hepatitis C Virus Card Test |
Rapid |
91.50 |
100.00 |
100.00 |
Bhat Bio-Tech India (P) Ltd.Hepa-Scan HCV ELISA (Pack |
Hepa-Scan HCV ELISA |
ELISA |
91.50 |
100.00 |
100.00 |
Biotech Inc. under license of J. Mitra & Co. Ltd., New Dehli
|
HCV Tri-Dot (Rapid) |
Rapid |
99.50 |
100.00 |
100.00 |
Biotechnologitzeskaja Kompanija Bioservis
|
HepaScreen |
ELISA |
99.00 |
100.00 |
96.00 |
Centro International de Investigacion yAdiestramiento Medico dela Universidad del Estado de Lousiana (LSU-ICMCosta Rica |
LSU-ICMrt EIA-Spep Screening Assay for Anti-HCV |
ELISA |
98.00 |
99.45 |
98.50 |
Dong-A PharmaceuticalCo., Ltd.(韩国) |
Dong-A HCV 3.0 |
ELISA |
99.00 |
100.00 |
98.00 |
SPAN Diagnostics Ltd. |
Signal HCV Flow Through Anti-HCV Spot / Immunodot Test Kit |
Rapid |
98.00 |
99.45 |
99.50 |
SPAN Diagnostics Ltd. marketed by Stimulus Specialty Diagnostics, Ltd. |
Innova HCV ELISA Test Kit |
ELISA |
99.50 |
100.00 |
98.50 |
Tecnosuma International S.A. |
Umelisa HCV 3ra Generacion |
ELISA |
under evaluation |
under evaluation |
under evaluation |
Union-Diagnostisches-System |
Anti-HCV ELISA |
ELISA |
99.50 |
99.45 |
97.00 |
Vector-Best |
RecombiBest anti-HCV- Strip (TMB) |
ELISA |
99.50 |
N/A |
N/A |
Vector-Best |
RecombiBest anti-HCV- Strip (OPD) |
ELISA |
100.00 |
99.45 |
97.50 |
WAMA Diagnóstica |
Imuno-RÁPIDO HCV |
Rapid |
99.50 |
98.90 |
98.00 |
Wiener Laboratories S.A.I.C. |
Hepatitis C (anti-HCV) ELISA |
ELISA |
100.00 |
99.45 |
97.50 |
Xcyton Diagnostics Ltd. marketed by Qualigens Fine Chemicals |
Hep-CheX C |
ELISA |
87.50 |
99.45 |
99.50 |
Labarotaroium Hepatika Mataram, 印尼 |
Entebe Anti HCV Dipstick |
Rapid |
under evaluation |
under evaluation |
under evaluation |
LG Life Sciences, Ltd.(汉城) |
LG HCD 3.0 Plus 96T |
ELISA |
100.00 |
100.00 |
99.50 |
Medizinische Biologische Union(俄罗斯) |
HCV- DCM |
ELISA |
99.50 |
99.45 |
97.50 |
NPP Akwapast(俄罗斯) |
Immunoenzyme Test-System for Detection of Anti-HCV |
ELISA |
99.00 |
N/A |
N/A |
Radiopreparat(乌兹别克斯坦) |
Anti-HCV ELISA |
ELISA |
98.00 |
100.00 |
98.00 |
说明:
N/A:不详(提供的检测试剂盒的质量不够满足试验)
(1) 使用由200个标本组成的ICBS HCV阳性血清盘,其包含已知基因型,ICBS通过从不同地区搜集而来(参见表2-a)。
(2) 特异性评估只要用181份已经确认的阴性样本即可,(来源于ICBS阴性血清盘的200份标本中——参见表2-b)。
排除有争议的19份样本,这些样本在不同的HCV印迹和5种欧洲的试验方法反应中成不确定性或者阳性结果。(参见表2-c)
(3)特异性评估使用ICBS阴性血清盘的200份标本(包括那19份标本)(参见表2-b)。
(4) 这些检测并不是评估的组成部分,结果仅为对照。