MediDia COVID-19 Ag
Manufactured by Medifood Hungary Innovation Kft., Hungary - https://www.medidia.hu/en/
Device identification number
2973
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, SARS-CoV, SARS-CoV-2
Pathogens detected
SARS-CoV, SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-09-20 10:58:53 CET
Comments
MediDia COVID-19 Ag is a rapid antigen test based on the license of the P4DETECT COVID-19 Ag rapid antigen test, manufactured by PRIME4DIA Co., Ltd. (South Korea). MediDia COVID-19 Ag is manufactured according to the same quality standards, using the same raw materials and production technology as those used in the production of P4DETECT COVID-19 Ag. MediDia COVID-19 Ag is identical to P4DETECT COVID-19 Ag.
There have been successful clinical studies carried out in multiple countries using P4DETECT COVID-19 Ag or STANDARD Q COVID-19 Ag, another rapid antigen test identical to P4DETECT COVID-19 Ag.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Quantitative
Time
20 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
800 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
% 0 out of 334
False negatives
2.63 % (3 out of 114)
Precision
Evaluated
Accuracy
99.33 %
Reproducibility
Evaluated
Clinical Sensitivity
97.37 % (Antigen)
Clinical Specificity
100 %
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