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UN. Descrizione

Il metodo di rilevamento di acido nucleico PCR è ancora lo standard d'oro per il rilevamento SARS-COV-2. Il patogeno può essere rilevato nelle prime fasi di infezione, ma la lunga operazione tat e ingombrante è la sua carenza.

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. Vantaggio e caratteristiche

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

CIBG Registration Letter/ 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/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/ ISO 13485 Certificate/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate

D. SARS-CoV-2 Antigen Test

per campioni nasali

Per il campione di saliva 5 set