See Now Coronavirus nCoV antigen test
Manufactured by CAMP MEDICA DISTRIBUTION, Romania - www.campmedica.ro
Device identification number
1999
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based, Manual
Physical Support
Card, Cassette, Lateral flow
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
04/16/2021 02:30
Comments
The “See Now” Coronavirus (SARS-CoV-2) Antigen test is an immunochromatographic lateral flow device that employs the principle of double antibody sandwich method. The “See Now” Coronavirus nCoV Antigen test is used for the qualitative detection of SARS-CoV-2 antigens in nasal swabs, nasopharyngeal swabs or oropharyngeal swabs.
Assay Type
Immuno-Antigen
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
1300 TCID50/ml (1.3 x102 TCID50/mL)
Positive control
yes
Negative control
yes
Analytical Sensitivity
97 %
Analitical Specificity
99 %
Clinical Sensitivity
97 %
Clinical Specificity
99 %
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements