Home Test COVID-19 Ag
Manufactured by Prognosis Biotech, Greece - https://www.prognosis-biotech.com
Device identification number
3615
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Other (Self-Testing Assay)
Physical Support
Cassette, 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), Influenza A, Influenza B
Pathogens detected
Other (None)
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-09-29 09:40:48 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
No
Self Test
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
358.75 TCID50/ml
Analytical Sensitivity
358.75 %
Analytical Specificity
100 %
False positives
4 samples
False negatives
6 samples
Accuracy
98.71 %
Clinical Sensitivity
96.85 %
Clinical Specificity
99.31 %
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