2019-nCoV Antigen Device

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2019-nCoV Antigen Device

Prestige Diagnostics UK Ltd
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Disease target
SARS-CoV-2
Regulatory status
CE-IVD
Time to result
0.25
Assay target
Antigen
Test format
Rapid diagnostic test (strip or cassette)
Technology principle
Lateral Flow Assay
Target analyte
N protein
Level of automation
Manual
Laboratory/Point-of-care
True Point of Care
Self-testing/Self-Collection
Intended for professional use only
Validated sample types
Nasopharyngeal swab
Connectivity
No
IMPACT OF SARS-COV-2 VARIANT:
Alpha - No expected impact (in silico analyses)
Beta - No expected impact (in silico analyses)
Gamma - Unknown
Manufacturer performance data
Sensitivity
96.4%
Specificity
99.2%