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

COVID-19 In Vitro Diagnostic Medical Device - detail

DS AntijenX

Manufactured by DS Bio and Nano Technology Product Tracking Verification Corp., Turkey - www.dsbionano.com 

Device identification number
2551
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
NA
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Other ()
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.44 % (6/417)
False negatives
0 % 0/417
Precision
Not evaluated
Accuracy
98.79 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
98.56 %
Clinical Specificity
99.38 %
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