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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV Antigen Device (Anterior Nasal Swab)

Manufactured by AMS UK (NI) Ltd., United Kingdom - www.amslabs.co.uk 

Device identification number
2605
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The 2019-nCoV Antigen Device (Anterior Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of nucleocapsid antigen of SARS-CoV-2 in anterior nasal swab samples.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
625 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.5 %
False negatives
3.7 %
Precision
Evaluated
Accuracy
98.1 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.3 %
Clinical Specificity
99.5 %
Type of antigen
Nucleocapsid protein

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