Rapid Test Ag 2019-nCov_Self Test

Rapid Test Ag 2019-nCov | Self Test

Catalog number: V1301

Rapid Test Ag 2019-nCoV Self-Test is a sensitive screening assay for the detection of SARS-CoV-2 antigen (nucleocapsid protein) in nasal swab specimens.

General Information:

Currently there are two types of diagnostics tests available for the detection of SARS-CoV-2 in human specimens: The molecular tests that detect the virus’s genetic material (RNA) and the antigen tests that detect specific viral proteins (known as antigens).

Nucleocapsid protein is the most abundant protein of coronavirus. During virion assembly, N protein binds to viral RNA and leads to formation of the helical nucleocapsid. Nucleocapsid protein is a highly immunogenic phosphoprotein also implicated in viral genome replication and in modulating cell signaling pathways. Because of the conservation of N protein sequence and its strong immunogenicity, the N protein of coronavirus is chosen as a diagnostic tool. The antigen (Nucleocapsid Protein, NP) is generally detectable during the acute phase of infection.


Lateral Flow kit characteristics:

■ Lateral flow assay (cassette format)

■ For private use/home use/self-testing

■ Clinical Evaluation Study with 370 specimens (prior confirmed with RT-PCR assay) showed: 96.33% sensitivity & 99.62% specificity

■ Clinical performance with 528 nasal specimens (prior confirmed with RT-PCR assay) showed: 98.59% sensitivity & 99.74% specificity

■ Rapid Test Ag 2019-nCov is confirmed to detect also the new dominant variants of SARS-CoV-2, known as the UK (B.1.1.7), South African (B.1.351) and Brazilian (P.1) variants

■ Visual interpretation of the results in 15 mins

■ Easy-to-use method

■ Using a minimally invasive nasal swab

■ The product has been granted a special authorization from the National Organization for Medicines (EOF) for use in Greece, with Ref No: 33853/ 09-04-2021

■ The kit contains all reagents required for the immunoassay method

■ Shelf Life: 12 months | Storage 4-30 oC

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