COVID-19 Antigen Rapid Test Kit (Colloidal Gold) -for self-testing
Manufactured by Jiangsu Konsung Bio-Medical Science And Technology Co. Ltd., China - www.konsung.com
Device identification number
3076
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza B Victoria, MERS-CoV, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Lineages detected
B.1.1.529 (Omicron)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
other pathogens tested: Adenovirus type 5, Enterovirus 68, Dengue Virus Type-1
Assay Type
Immuno-Antigen
Self Test
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
50 (pg/ml)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
3 AU
False negatives
16 AU
Precision
Evaluated
Accuracy
97.254 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.103 % (Antigen)
Clinical Specificity
99.348 % (Antigen)
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