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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Rapid COVID-19 Antigen Test

Manufactured by Healgen Scientific, United States - https://www.healgen.com/ 

Device identification number
1735
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card, Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
115 U/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.35 % (3 of 865)
False negatives
0.23 % (2 of 865)
Precision
Not evaluated
Accuracy
99.42 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
98.32 %
Type of antigen
Nucleoprotein

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