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RAPID TEST AG 2019-NCOV

V1330
Lateral Flow Test
Prognosis Biotech
30 tests

DESCRIPTION:
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.

CHARACTERISTICS:
- Lateral flow in dip stick format available in 10 and 30 test sticks
- 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
- Visual interpretation of the results in 15 mins
- Simple method, no need for special equipment
- Applications: Healthcare, ports of entry, working & operating environments, universities & schools
- Shelf Life: 12 months | Storage 4-30 oC
- The test has received the CE-IVD mark and therefore is approved for diagnostic use in the E.U.
- Test should only be conducted by medical personnel