COVID-19 Antigen Detection Kit
Manufactured by DNA Diagnostic, Denmark - https://dna-diagnostic.com/
Device identification number
2242
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
No additional information
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
160 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.44 % (1 out of 226 true negatives compared to PCR)
False negatives
6.25 % (9 out of 144 true positives compared to PCR)
Precision
Evaluated
Accuracy
97.3 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
93.8 %
Clinical Specificity
99.6 %
Type of antigen
Nucleoprotein
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