Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

OnSite COVID-19 Ag Rapid Test

Manufactured by CTK Biotech, Inc, United States - https://ctkbiotech.com/ 

Device identification number
1581
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-07 05:10:05 CET
Comments
This test is registered and for practical use in: Germany Bfarm https://antigentest.bfarm.de/ords/f?p=110:100:1379568298725:::::&tz=-7:00 Test ID AT390/21 Italy MOH https://www.salute.gov.it/interrogazioneDispositivi/RicercaDispositiviServlet?action=ACTION_MASCHERA Under CTK Biotech, Inc. Device registration number is 2095755 France ANSM https://covid-19.sante.gouv.fr/tests Denmark authorization: https://laegemiddelstyrelsen.dk/da/udstyr/covid-19-antigen-test-og-ivd/covid-19-antigen-test-til-selvtest/ Practical usage: To date, there are 11211460 tests that are in use or scheduled to be shipped to EU in the countries of Denmark, France, Germany, Italy, Ireland, Romania, Lithuania and the United Kingdom.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colorimetry
LOD
280 %
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
7.7 %
Precision
Evaluated
Accuracy
100 %
Accuracy
98.9 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.3 %
Clinical Specificity
100 %
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