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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Covid-19 Antigen Schnelltest (Colloidales Gold)

Manufactured by IEDAU INTERNATIONAL GMBH, Germany

Device identification number
2555
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal 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), Enterovirus A71 (EV-A71), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Lineages detected
A.23.1, AT.1, 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
2022-08-24 09:08:01 CET
Comments
The product is listed by BfArM with AT1204/21,and has positive results by PEI.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.8 % (Nasal swab)
False positives
0.8 % (Oropharyngeal swab)
False positives
0.8 % (Nasopharyngeal swab)
False negatives
3.9 % (Oropharyngeal swab)
False negatives
2.9 % ( Nasopharyngeal swab)
False negatives
3.9 % (Nasal swab)
Precision
Evaluated
Accuracy
98.7 % (Nasal swab)
Accuracy
98.7 % (Oropharyngeal swab)
Accuracy
98.8 % (Nasopharyngeal swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.1 % (Nasal swab)
Clinical Sensitivity
96.1 % (Oropharyngeal swab)
Clinical Sensitivity
97.1 % ( Nasopharyngeal swab)
Clinical Specificity
99.2 % (Oropharyngeal swab)
Clinical Specificity
99.2 % (Nasopharyngeal swab)
Clinical Specificity
99.2 % (Nasal swab)
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