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

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Antigen Rapid Test (Immunochromatography)

Manufactured by SHANDONG KANGHUA BIOTECHNOLOGY Co. Ltd., China - WWW.KHBIO.COM 

Device identification number
1366
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal 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
Colorimetry
LOD
1400 AU
False positives
0.25 % (1 false positive to 400 negative samples)
False negatives
5 % (5 false negatives to 100 positive samples)
Accuracy
98.8 % ((Antigen))
Clinical Sensitivity
95 % ((Antigen))
Clinical Specificity
99.75 %
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