E-Diag   WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD  明德生物   核酸试剂   4-8-2020   http://testkit.bz/ed  ( "Inter-Office Study, not for Public Use...)

感谢您关注明德生物(证券代码:002932)!     [  RT-PCR Test kit  ]
武汉明德生物科技股份有限公司(002932.SZ) 成立于2008年,坐落于国家生物产 业基地——武汉光谷生物城。
是一家专业从事体外诊断试剂及配套仪器(POCT\分子诊断\化学发光\血气等)产品以及胸痛中心、卒中中心、心电网络等医疗服务的国家高新技术企业。
国内高通量POCT倡导者,胸痛中心、卒中中心及远程心电网络建设者。湖北省企业技术中心,武汉市企业研究开发中心单位。
目前主营业务已覆盖全国30个省、直辖市、自治区,同时在亚洲、欧盟、南美等多个区域实现销售覆盖。公司于2018年7月10日在深交所挂牌上市,股票代 码002932
明德生物为您提供POCT、化学发光、分子诊断、血气分析等诊断产品服务,还提供胸痛中心、卒中中心、心电网络等医疗服务!拨打400-880-2480进行咨询。


ED Advantage & Dis-Advantage:    (commented by: vic  4-10-2020)

**Advantage:
1. Have larger Produce Capacity & Product Stock                            2. Cn Stock Market Listing Company.
3. Have Comparision Trial Report:  success rate: 95%                       4. Kit: RT-PCR method (RT=Real Time)

**Dis-Advantage:
    1. Price Jump... 44% one day  (4-8 to 4-9)  Due to Reasons?  *-#@!~]&..   2. Storage LowTemp request....[--20+-5C]    3. WuHan
1. Technical specification for all products(产品的技术规范)
2、certifications for all products that have(产品取得的证书)
3、documentation for all standards that the products that reach different standards
(产品所有取得的标准的文件)
1)CFDA
    CE符合性声明  
    FDA
1)营业执照 (空)
2) ISO13485认证
3) 一类医疗器械备案证
4)第一类体外诊断试剂备案信息表
5)二类医疗器械经营备案凭证变更
1. Delivery time to Denmark :           7-10日交货
5、country of origin(原产地) :          China
6、quantity available可订货数量    1,00,000pieces

CN Mfr List - Test Kit








                                       <  -25C to -15C  >
Follows the Chinese companies that can produce and export the test kits.
Seven  empresas chinesas que têm autorização:
1. 广州万孚生物技术股份有限公司 (Wondfo)
     https://en.wondfo.com.cn/ (inglês)
     https://www.wondfo.com.cn/(chinês)
2. 英诺特(唐山)生物技术有限公司(Innovita)
     http://www.innovita.com.cn/index.html (inglês)
     http://www.innovita.com.cn/html/cn/ (chinês)
3. 博奥赛斯(重庆)生物科技有限公司(Bioscience)
     http://www.bioscience-tj.com/en/ (inglês)
     http://www.bioscience-tj.com/?zh=en (chinês)
4. 厦门万泰凯瑞生物技术有限公司(Innodx) 
     http://www.innodx.com/about/?19.html (chinês)
     http://www.innodx.com/about/?27.html (contato)
5. 广东和信健康科技有限公司(Hecin) 
     http://www.hecin-scientific.cn/ (chinês)     http://www.hecin-scientific.cn/ChannelArticle.aspx?id=00d0ad05-1dda-4dd0-8c97-4108309faf20&cid=599&pcid=575 (contato)

6. 南京诺唯赞医疗科技有限公司(Vazyme)  
     http://www.vazymebiotech.com/ (inglês)
     http://www.vazymemedical.com/ (chinês)
     http://www.vazyme.com/rencai.html?introId=16#dl (página especial do COVID-19)
7. 珠海丽珠试剂股份有限公司(Livzon) 
    http://www.livzondiagnostics.com/index.php?l=en (inglês)
    http://www.livzondiagnostics.com/(chinês)
  (上面是巴西中国总领事馆提供的清单,如果你的供货商是在名单内,可以省了很多力气)

 E-Diag   Clinical Trial Results

Clinical performance                Clinical Trial Results     Date: _____ ,2020

 [Purposes]
Use Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (Multiple Fluorescence PCR)
 (hereinafter referred to as "this kit") produced by Wuhan EasyDiagnosis Biomedicine Co., Ltd. for clinical evaluation, and verify its safety and effectiveness.

 [Methods]
 ① Through a comparative study with clinically confirmed/excluded results, make a comparison by using the clinical sensitivity, clinical specificity and clinical accuracy for statistical analysis of the results, and evaluate the clinical performance of the evaluated reagent.
② Through comparison with similar products already on the market, make a comparison by using     
          negative accordance rate,
          positive accordance rate and
          Kappa identity test for statistical analysis of the results, and
      verify whether the evaluated reagent is equivalent to the similar product to detect 2019-nCoV.

 [Results]
 ① The comparative study of the evaluated reagents with clinically confirmed/excluded results for a total of 681 cases is completed, and 681 statistical cases are included,
including 288 confirmed cases and 393 excluded cases.
Comparison between evaluated reagent test results and clinically confirmed/excluded results meets the standards as follows:
a) The clinical sensitivity is 95.14%, and the 95% confidence interval is 93.52%~96.75%;
b) The clinical specificity is 95.93%, and the 95% confidence interval is 94.44%~97.41%;
c) The clinical accuracy   is 95.59%, and the 95% confidence interval is 94.05%~97.14%.

② The comparative study of the evaluated reagents with similar products on the market for a total of 756 cases is completed, 6 cases are excluded (specimens repeatedly included in the group), and 750 cases are finally included, including 295 positive cases accounting for 39.33% of the total specimens, as well as 455 negative cases accounting for 60.67% of the total specimens.

There are 342 oropharyngeal   swab specimens,
                      including 149 positive cases and 193 negative cases;  
               249 nasopharyngeal swab specimens,
                      including 73 positive cases and 176 negative cases; and
               159 sputum specimens,
                      including 73 positive cases and 86 negative cases.

 Adopt evaluated reagent negative and positive test results,
     and compare reagent negative and positive test results to meet the standards as follows:
 a) Negative accordance rate is 94.07%, and 95% confidence interval is 92.38%~95.76%;
 b) Positive  accordance rate is 95.93%, and 95% confidence interval is 94.52%~97.35%;
 c) Total accordance rate is 94.80%, 95% confidence interval 93.21%~96.39%;
 d) Kappa identity test K value is 0.8920, and 95% confidence interval is 0.8590~0.9250.

 [Conclusions]
 ① The comparison between the evaluated reagent test results and the clinically confirmed/excluded results shows high consistency, indicating that the evaluated reagents have good clinical applicability.
 ② The evaluated reagents have high consistency with the comparison reagents, indicating that the evaluated reagents meet the requirements for safety and effectiveness in clinical use and have good clinical applicability.

Data source: General Clinical Trial Report on Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (Multiple Fluorescence PCR)


四个东西,搭配使用,才能完成一个核酸检测。 4个瓶子一组是25人份。一个盒子装4*4个瓶子,为100人份。
 Above wt & Dimension are not correct...4-10-2020 vic







inter-office communication...   see     personal file