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TC1002
Bioteke
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. Product Qualification
CE Certification –CIBG Registration Letter/ CE Certification –CIBG Registration Prove/ CE Certification –EC Declaration of Conformity/ MHRA Registration/ MHRA Registration- UKCA Declaration of Conformity/ EU COVID-19 In Vitro Diagnostic Devices and Test Methods Database/ Export Qualified Suppliers/ Export Qualified Suppliers (German BfarM special approval for self-test)/ Bfarm Special approval/ Bfarm List of Antigen-tests of the coronavirus SARS-CoV-2/ PEI tests/ Czech List of antigenic tests for which issued by the ministry exemption/ Austria Registration/ Italy Registration/ Nepal List of approved COVID-19 Antigen Kits/ EU HSC common list/ EU HSC common list/ FIND list of immunoassays and molecular tests for COVID-19/ Malaysia List of Recommended for Use of Covid-19 IVD Test kit (Professional use only)/ Swiss Lists of rapid tests for SARS-CoV-2 for professional use/ Bulgaria list of rapid antigen test/ France COVID-19 Diagnostic test list - For
nasopharyngeal swab/ Thailand List of Test Kits for COVID-19 -Antigen Rapid Test (Professional Use Only)/ Thailand List of Test Kits for COVID-19 -Antigen Rapid Test (Professional Use Only)/ Bangladesh Emergency Use Authorization (EUA)/ Indonesia Registration/ Belgium famhp List of the recommended tests/ Ghana Registration/ Saudi Arabia Registration/ Thailand Clinical evaluation-1/ Thailand Clinical evaluation-2/ ISO 13485 Certificate-MDSAP/ ISO 13485 Certificate/ ISO 9001 Certificate/ Free Sale Certificate-Ghana/ ISO 13485 Certificate-MDSAP/ ISO 9001Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate
D. SARS-CoV-2 Antigen Test
Name | Specification | components |
Anterior nasal sample collection | 1 kit /5 kit/ 10 kit /20 kit | test card ,sample duilent, sample extraction tube,sampling swab |
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. Product Qualification
CE Certification –CIBG Registration Letter/ CE Certification –CIBG Registration Prove/ CE Certification –EC Declaration of Conformity/ MHRA Registration/ MHRA Registration- UKCA Declaration of Conformity/ EU COVID-19 In Vitro Diagnostic Devices and Test Methods Database/ Export Qualified Suppliers/ Export Qualified Suppliers (German BfarM special approval for self-test)/ Bfarm Special approval/ Bfarm List of Antigen-tests of the coronavirus SARS-CoV-2/ PEI tests/ Czech List of antigenic tests for which issued by the ministry exemption/ Austria Registration/ Italy Registration/ Nepal List of approved COVID-19 Antigen Kits/ EU HSC common list/ EU HSC common list/ FIND list of immunoassays and molecular tests for COVID-19/ Malaysia List of Recommended for Use of Covid-19 IVD Test kit (Professional use only)/ Swiss Lists of rapid tests for SARS-CoV-2 for professional use/ Bulgaria list of rapid antigen test/ France COVID-19 Diagnostic test list - For
nasopharyngeal swab/ Thailand List of Test Kits for COVID-19 -Antigen Rapid Test (Professional Use Only)/ Thailand List of Test Kits for COVID-19 -Antigen Rapid Test (Professional Use Only)/ Bangladesh Emergency Use Authorization (EUA)/ Indonesia Registration/ Belgium famhp List of the recommended tests/ Ghana Registration/ Saudi Arabia Registration/ Thailand Clinical evaluation-1/ Thailand Clinical evaluation-2/ ISO 13485 Certificate-MDSAP/ ISO 13485 Certificate/ ISO 9001 Certificate/ Free Sale Certificate-Ghana/ ISO 13485 Certificate-MDSAP/ ISO 9001Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate
D. SARS-CoV-2 Antigen Test
Name | Specification | components |
Anterior nasal sample collection | 1 kit /5 kit/ 10 kit /20 kit | test card ,sample duilent, sample extraction tube,sampling swab |
