Medicovid-AG SARS-CoV-2 Antigen Selbsttest-Nase
Manufactured by MEDICE Arzneimittel Pütter GmbH & Co. KG, Germany - www.medice.de
Device identification number
2318
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card, Cartridge, Dipstick, Lateral flow, Strip
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Rhinovirus
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
If you need any further information, please do not hesitate to contact me.
Assay Type
Immuno-Antigen
Reader Required
No
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
AU 130
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
4 AU
Precision
Evaluated
Accuracy
98.73 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.19 %
Clinical Specificity
99.2 %
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