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TC1002
BioTeke
Warm warning: This product is not available for US market.
A. Description
Nucleic acid PCR detection method is still the gold standard for SARS-CoV-2 detection. The pathogen can be detected in the early stages of infection, but the long TAT and cumbersome operation are its shortage.
Antigen test is with short TAT and simple operation, but it has a window period. Generally, it can only be detected in 1-2 weeks after infection.
B. Advantage&Features
Although the development cycle of antigen detection is relatively long, its
1. Sensitivity and specificity are higher than antibody detection
2. The pathogen can be detected at the initial stage of infection
3. Short TAT and simple operation.
4. No professional technicians and equipment are required, and the test can be completed in 15 min.
5. Home use.
6. Personal test.
C. Specification
Name | Specification | components |
Anterior nasal sample collection | 1 kit /5 kit/ 10 kit /20 kit | test card ,sample duilent, sample extraction tube,sampling swab |
D. Product Qualifications（by Dec.2nd,2022）
| SARS-CoV-2 Antigen Test Kit (For professional use) 新型冠状病毒抗原检测试剂盒 | |
| CE Certification – CIBG Registration Letter | CE 证书-CIBG 注册信 |
| CE Certification –CIBG Registration Prove | CE 证书-CIBG 网站注册证明 |
| CE Certification–EC Declaration of Conformity | CE 证书-EC 符合性声明 |
| EU COVID-19 In Vitro Diagnostic Devices and Test Methods Database | 欧盟新冠诊断试剂清单 |
| Export Qualified Suppliers | 商务部出口白名单 |
| PEI tests | PEI 检测 |
| Austria Registration | 奥地利注册 |
| Italy Registration | 意大利注册 |
| Nepal List of approved COVID-19 Antigen Kits | 尼泊尔政府推荐抗原清单 |
| EU HSC common list | 欧盟抗原检测卡通用清单 |
| FIND list of immunoassays and molecular tests for COVID-19 | FIND COVID-19 免疫检测和分子检测清单 |
| Malaysia List of Recommended for Use of Covid-19 IVD Test kit (Professional use only) | 马来西亚推荐使用 Covid-19 IVD 试剂盒清单（仅限专业使用） |
| Swiss Lists of rapid tests for SARS-CoV-2 for professional use | 瑞士供专业使用的 SARS-CoV-2 快速检测清单 |
| Bulgaria list of rapid antigen test | 保加利亚抗原快速检测清单 |
| France COVID-19 Diagnostic test list - For nasopharyngeal swab | 法国 COVID-19 诊断试剂清单-鼻咽拭子 |
| Thailand List of Test Kits for COVID-19 - Antigen Rapid Test (Professional Use Only) | 泰国抗原白名单（专业版） |
| Bangladesh Emergency Use Authorization (EUA) | 孟加拉国紧急使用授权 |
| Belgium famhp List of the recommended tests | 比利时 famhp 检测试剂推荐清单 |
| Ghana Registration | 加纳注册 |
| Saudi Arabia Registration | 沙特注册 |
| Peru Registration | 秘鲁注册 |
| Peru Registration | 秘鲁注册 |
| Albania Registration | 阿尔巴尼亚注册 |
| Macao list of authorized covid-19 rapid antigen tests | 澳门获批准进口新冠病毒快速抗原检测试剂清单 |
| Thailand Clinical evaluation-1 | 泰国临床报告-1（前鼻拭子+鼻咽拭子） |
| Thailand Clinical evaluation-2 | 泰国临床报告-2（鼻咽拭子） |
| Free sale certificate-Malaysia | 自由销售证明-马来西亚 |
| Free sale certificate-Mexico | 自由销售证明-墨西哥 |
| Free sale certificate-Indonesia | 自由销售证明-印尼 |
| Free sale certificate-Sri Lanka | 自由销售证明-斯里兰卡 |
| Free sale certificate-United Arab Emirates | 自由销售证明-阿联酋 |
| Free Sale Certificate-United States | 自由销售证明书-美国 |
| Free Sale Certificate-Peru | 自由销售证明书-秘鲁 |
| Free Sale Certificate-Thailand | 自由销售证明书-泰国 |
| Free Sale Certificate-Vietnam | 自由销售证明书-越南 |
| Free Sale Certificate-Algeria | 自由销售证明书-阿尔及利亚 |
| Free Sale Certificate-Cambodia | 自由销售证明书-柬埔寨 |
| Free Sale Certificate-Ghana | 自由销售证明书-加纳 |
| ISO 13485 Certificate | ISO 13485 证书 |
| ISO 9001 Certificate | ISO 9001 证书 |
| ISO 45001 Certificate | ISO 45001职业健康安全管理体系认证证书 |
| ISO 14001 Certificate | ISO 14001环境管理体系认证证书 |
| IPMS Certificate | 知识产权管理体系认证证书 |
Warm warning: This product is not available for US market.
A. Description
Nucleic acid PCR detection method is still the gold standard for SARS-CoV-2 detection. The pathogen can be detected in the early stages of infection, but the long TAT and cumbersome operation are its shortage.
Antigen test is with short TAT and simple operation, but it has a window period. Generally, it can only be detected in 1-2 weeks after infection.
B. Advantage&Features
Although the development cycle of antigen detection is relatively long, its
1. Sensitivity and specificity are higher than antibody detection
2. The pathogen can be detected at the initial stage of infection
3. Short TAT and simple operation.
4. No professional technicians and equipment are required, and the test can be completed in 15 min.
5. Home use.
6. Personal test.
C. Specification
Name | Specification | components |
Anterior nasal sample collection | 1 kit /5 kit/ 10 kit /20 kit | test card ,sample duilent, sample extraction tube,sampling swab |
D. Product Qualifications（by Dec.2nd,2022）
| SARS-CoV-2 Antigen Test Kit (For professional use) 新型冠状病毒抗原检测试剂盒 | |
| CE Certification – CIBG Registration Letter | CE 证书-CIBG 注册信 |
| CE Certification –CIBG Registration Prove | CE 证书-CIBG 网站注册证明 |
| CE Certification–EC Declaration of Conformity | CE 证书-EC 符合性声明 |
| EU COVID-19 In Vitro Diagnostic Devices and Test Methods Database | 欧盟新冠诊断试剂清单 |
| Export Qualified Suppliers | 商务部出口白名单 |
| PEI tests | PEI 检测 |
| Austria Registration | 奥地利注册 |
| Italy Registration | 意大利注册 |
| Nepal List of approved COVID-19 Antigen Kits | 尼泊尔政府推荐抗原清单 |
| EU HSC common list | 欧盟抗原检测卡通用清单 |
| FIND list of immunoassays and molecular tests for COVID-19 | FIND COVID-19 免疫检测和分子检测清单 |
| Malaysia List of Recommended for Use of Covid-19 IVD Test kit (Professional use only) | 马来西亚推荐使用 Covid-19 IVD 试剂盒清单（仅限专业使用） |
| Swiss Lists of rapid tests for SARS-CoV-2 for professional use | 瑞士供专业使用的 SARS-CoV-2 快速检测清单 |
| Bulgaria list of rapid antigen test | 保加利亚抗原快速检测清单 |
| France COVID-19 Diagnostic test list - For nasopharyngeal swab | 法国 COVID-19 诊断试剂清单-鼻咽拭子 |
| Thailand List of Test Kits for COVID-19 - Antigen Rapid Test (Professional Use Only) | 泰国抗原白名单（专业版） |
| Bangladesh Emergency Use Authorization (EUA) | 孟加拉国紧急使用授权 |
| Belgium famhp List of the recommended tests | 比利时 famhp 检测试剂推荐清单 |
| Ghana Registration | 加纳注册 |
| Saudi Arabia Registration | 沙特注册 |
| Peru Registration | 秘鲁注册 |
| Peru Registration | 秘鲁注册 |
| Albania Registration | 阿尔巴尼亚注册 |
| Macao list of authorized covid-19 rapid antigen tests | 澳门获批准进口新冠病毒快速抗原检测试剂清单 |
| Thailand Clinical evaluation-1 | 泰国临床报告-1（前鼻拭子+鼻咽拭子） |
| Thailand Clinical evaluation-2 | 泰国临床报告-2（鼻咽拭子） |
| Free sale certificate-Malaysia | 自由销售证明-马来西亚 |
| Free sale certificate-Mexico | 自由销售证明-墨西哥 |
| Free sale certificate-Indonesia | 自由销售证明-印尼 |
| Free sale certificate-Sri Lanka | 自由销售证明-斯里兰卡 |
| Free sale certificate-United Arab Emirates | 自由销售证明-阿联酋 |
| Free Sale Certificate-United States | 自由销售证明书-美国 |
| Free Sale Certificate-Peru | 自由销售证明书-秘鲁 |
| Free Sale Certificate-Thailand | 自由销售证明书-泰国 |
| Free Sale Certificate-Vietnam | 自由销售证明书-越南 |
| Free Sale Certificate-Algeria | 自由销售证明书-阿尔及利亚 |
| Free Sale Certificate-Cambodia | 自由销售证明书-柬埔寨 |
| Free Sale Certificate-Ghana | 自由销售证明书-加纳 |
| ISO 13485 Certificate | ISO 13485 证书 |
| ISO 9001 Certificate | ISO 9001 证书 |
| ISO 45001 Certificate | ISO 45001职业健康安全管理体系认证证书 |
| ISO 14001 Certificate | ISO 14001环境管理体系认证证书 |
| IPMS Certificate | 知识产权管理体系认证证书 |
