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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AMPER COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) (at-home)

Manufactured by AMPER INC, United States - http://www.amperbio.com 

Device identification number
2874
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab, Saliva
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-01-05 03:58:29 CET
Comments
See the instructions for use.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
78 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
3 %
Precision
Evaluated
Accuracy
98.03 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.62 % (Antigen)
Clinical Specificity
99.44 % (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