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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

RAPiDgen SARS-CoV-2 Ag Test

Manufactured by ADALTIS srl, Italy - www.adaltis.net/ 

Device identification number
2896
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based, Manual, Near POC / POC
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-01-04 04:58:02 CET
Comments
For all study participants the antigen rapid test correctly identified 91.87% of infected participants, and 99.04% of noninfected participants . For patients with a relatively high viral load (Ct≤30), the relative sensitivity was 95.74% (N=188). The RAPiDgenSARS-CoV-2 Ag Test detects SARS-CoV-2 nucleoprotein (N). This protein has 419 amino acids. The RAPiDgenSARS-CoV-2 Ag Test detects the C-terminal end of this protein (specifically AA247-364)
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
LOD
400 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.95 % (4 on 418 negative samples tested during the clinical trial)
Fn
8.12 % (16 on 197 positive samples tested during the clinical trial)
Precision
Evaluated
Accuracy
96.75 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.87 % (Antigen)
Clinical Specificity
0.04 % (Antigen)
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