HIV1+2 (HIV MANUAL)
基本信息
产品名称：
HIV1+2 (HIV MANUAL)
英文名称：
HIV1+2 (HIV MANUAL)
国产/进口：
产地/品牌：
型号：
参考报价：
唐丽娅13701223090
销售商：
总点击数：
2580
更新日期：
2007-03-09
产品类别：
性能参数
Kewei is the first company that realizes the industry and commercializing of HIV Ag/P24 Ab diagnostic kit successfully; enjoying the patent technology in China; improving sensitivity and decreasing risk for getting HIV; adding the detection of P24 antigen and shortening the window period; 12 months expiration date, high sensitivity and specialty and stable product quality.
中国区域独享专利技术，国内第一家成功实现艾滋抗体和艾滋P24抗原联合检测试剂的商品化和产业化；提高了试剂灵敏度，降低因输血感染艾滋的风险；增加P24抗原检测指标，减小了检测窗口期；长达12个月的有效期，灵敏度、特异性具佳，产品质量更稳定。
Data of Clinical Trials
临床考核数据
Results of multicenter clinical trials
Samples The third generation importation kit The forth generation kit of Kewei
Number of detection Number of positive Number of negative Number of detection Number of positive Number of negative
Definite HIV positive samples 179 0 179 179 0 179
Definite HIV negative samples 4521 4520 1 4521 4519 2
Total 4700 4520 180 4700 4519 181
多中心临床考核结果
参评试剂样本 进口三代检测试剂 科卫四代抗原抗体联检试剂
检测数 阴性数 阳性数 检测数 阴性数 阳性数
已确认HIV阳性样本 179 0 179 179 0 179
已确认HIV阴性样本 4521 4520 1 4521 4519 2
总计 4700 4520 180 4700 4519 181
Results of a clinical trial in national institute for the control of pharmaceutical and biological products(NICPBP)
The forth generation kit of Kewei Total
The third generation importation kit Positive Negative
Positive 112 1 113
Negative 2 5 7
Total 114 6 120
中国生物制品检定所临床考核结果
科卫四代抗原抗体联检试剂 合计
进口三代试剂 阳性数 阴性数
阳性数 112 1 113
阴性数 2 5 7
总计 114 6 120
Results of comparing with definite kit
WB definite kit The third generation importation kit RNA detection P24 detection The forth generation kit of Kewei
No band Negative Negative Negative Positive
No band Positive Negative Negative Negative
No band Negative Positive Positive Positive
确认比较结果
WB确认试剂 进口三代 RNA检测 P24检测 科卫四代
无条带 阴性 阴性 阴性 阳性
无条带 阳性 阴性 阴性 阴性
无条带 阴性 阳性 阳性 阳性
Resultsof anti-interference testing
Interference factors(samples) The forth generation kit of Kewei Definite kit
Negative Positive Negative Positive
HBsAg+, HBeAg+, HBcAb+ 18 0 18 0
HBsAg+, HBeAb+, HBcAb+ 15 0 15 0
HBsAg+ 32 0 32 0
HBsAb+ 42 0 42 0
Anti-HCV+ 68 0 68 0
Anti-Rubella Virus 5 0 5 0
RF+ 7 0 7 0
Kidney disease 11 0 11 0
SLE 3 0 3 0
抗干扰能力测试
干扰因素 科卫四代结果 确认结果
阴性 阳性 阴性 阳性
大三羊标本 18 0 18 0
小三羊标本 15 0 15 0
表面抗原阳性标本 32 0 32 0
表面抗体阳性标本 42 0 42 0
丙肝抗体阳性标本 68 0 68 0
风疹阳性标本 5 0 5 0
类风湿因子阳性标本 7 0 7 0
肾病病人标本 11 0 11 0
红瘢狼疮病人标本 3 0 3 0
中国区域独享专利技术，国内第一家成功实现艾滋抗体和艾滋P24抗原联合检测试剂的商品化和产业化；提高了试剂灵敏度，降低因输血感染艾滋的风险；增加P24抗原检测指标，减小了检测窗口期；长达12个月的有效期，灵敏度、特异性具佳，产品质量更稳定。
Data of Clinical Trials
临床考核数据
Results of multicenter clinical trials
Samples The third generation importation kit The forth generation kit of Kewei
Number of detection Number of positive Number of negative Number of detection Number of positive Number of negative
Definite HIV positive samples 179 0 179 179 0 179
Definite HIV negative samples 4521 4520 1 4521 4519 2
Total 4700 4520 180 4700 4519 181
多中心临床考核结果
参评试剂样本 进口三代检测试剂 科卫四代抗原抗体联检试剂
检测数 阴性数 阳性数 检测数 阴性数 阳性数
已确认HIV阳性样本 179 0 179 179 0 179
已确认HIV阴性样本 4521 4520 1 4521 4519 2
总计 4700 4520 180 4700 4519 181
Results of a clinical trial in national institute for the control of pharmaceutical and biological products(NICPBP)
The forth generation kit of Kewei Total
The third generation importation kit Positive Negative
Positive 112 1 113
Negative 2 5 7
Total 114 6 120
中国生物制品检定所临床考核结果
科卫四代抗原抗体联检试剂 合计
进口三代试剂 阳性数 阴性数
阳性数 112 1 113
阴性数 2 5 7
总计 114 6 120
Results of comparing with definite kit
WB definite kit The third generation importation kit RNA detection P24 detection The forth generation kit of Kewei
No band Negative Negative Negative Positive
No band Positive Negative Negative Negative
No band Negative Positive Positive Positive
确认比较结果
WB确认试剂 进口三代 RNA检测 P24检测 科卫四代
无条带 阴性 阴性 阴性 阳性
无条带 阳性 阴性 阴性 阴性
无条带 阴性 阳性 阳性 阳性
Resultsof anti-interference testing
Interference factors(samples) The forth generation kit of Kewei Definite kit
Negative Positive Negative Positive
HBsAg+, HBeAg+, HBcAb+ 18 0 18 0
HBsAg+, HBeAb+, HBcAb+ 15 0 15 0
HBsAg+ 32 0 32 0
HBsAb+ 42 0 42 0
Anti-HCV+ 68 0 68 0
Anti-Rubella Virus 5 0 5 0
RF+ 7 0 7 0
Kidney disease 11 0 11 0
SLE 3 0 3 0
抗干扰能力测试
干扰因素 科卫四代结果 确认结果
阴性 阳性 阴性 阳性
大三羊标本 18 0 18 0
小三羊标本 15 0 15 0
表面抗原阳性标本 32 0 32 0
表面抗体阳性标本 42 0 42 0
丙肝抗体阳性标本 68 0 68 0
风疹阳性标本 5 0 5 0
类风湿因子阳性标本 7 0 7 0
肾病病人标本 11 0 11 0
红瘢狼疮病人标本 3 0 3 0
公司简介
Beijing Jinsheng Lida Bio-Tech Co. Ltd (BJLB) is a professional kits (ELISA/ Rapid Diagnostic) and medical instrument provider, and engages in offering products with dependable quality and excellent performance to all over the world.
BJLB possesses a well trained sale team to ensure to provide 24 hour high quality service; BJLB possesses professional technical consultants, and can duly resolve any problems during the use; Before sent to clients, our products are monitored rigidly during the whole course, so that the quality thereof can be assured.
BJLB regards “create one grade quality and service, contribute to the mankind health” as the management policy to serve society and public.
BJLB possesses a well trained sale team to ensure to provide 24 hour high quality service; BJLB possesses professional technical consultants, and can duly resolve any problems during the use; Before sent to clients, our products are monitored rigidly during the whole course, so that the quality thereof can be assured.
BJLB regards “create one grade quality and service, contribute to the mankind health” as the management policy to serve society and public.
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