COVID19-CHECK1 ANTIGEN
Manufactured by VEDALAB, France - www.vedalab.com
Device identification number
1956
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal 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), Influenza A H1N1, Influenza B, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV)
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Professional version is also CE marked and available
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
LOD
0.05 ng/mL (recombinant nucleoprotein)
Analysis of cross reactivity
Evaluated
False positives
0.33 % (specificity 99.67%)
False negatives
0.92 % (sensitivity 99.08% (Ct value <=25))
Precision
Evaluated
Accuracy
99.51 % (95% IC [98.14 - 100.00] (overall agreement))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.08 % (95% IC [94.67 - 100.00] for Ct<=25 (109 tested samples))
Clinical Specificity
99.67 % (95% IC [98.03 - 100.00] (300 tested samples))
Type of antigen
Nucleoprotein
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