Test Rapid Covid-19 Antigen (tampon nazal)
Manufactured by DDS DIAGNOSTIC SRL, Romania - www.ddsdiagnostic.com
Device identification number
2986
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cartridge, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Hemophilus Influenzae, Influenza A H1N1, Influenza A H3N2, Influenza B, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The performance evaluation of Covid-19 Antigen rapid test (Test Rapid Covid-19 Antigen (tampon nazal)), regarding the new variants is continuously updated according to DDS Diagnostic internal protocol.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
2.4 ng/mL
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.2 % (2 false negatives from 986 total samples)
False negatives
0.2 % (2 false positives from 986 total samples)
Precision
Evaluated
Accuracy
99.59 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.17 % (Antigen)
Clinical Specificity
99.73 % (Antigen)
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