SARS-CoV-2 Antigen Rapid Test (Nasal Swab) For Self-testing
Manufactured by DNA Diagnostic, Denmark - https://dna-diagnostic.com/
Device identification number
2814
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This test is identical to RAT ID 2756, but evaluated for self-test use and packaged and sold as such.
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
100 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.6 % (3 out of 500 true negatives compared to PCR)
False negatives
4.61 % (16 out of 347 true positives compared to PCR)
Precision
Evaluated
Accuracy
97.8 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
95.4 %
Clinical Specificity
99.4 %
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