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

COVID-19 In Vitro Diagnostic Medical Device - detail

ADTech COVID-19 Ag RAPID KIT

Manufactured by ADTech Co., LTD, South Korea - www.adtchip.com 

Device identification number
2736
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
ADTech COVID-19 Ag RAPID KIT is based on immunochromatography for the qualitative determination of SARS-CoV-2 virus specific antigens in human Nasopharyngeal swab specimen.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
LOD
339 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.33 % (1 out of 300)
Fn
8 % (8 out of 100)
Precision
Evaluated
Accuracy
95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92 %
Clinical Specificity
99.67 %
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