RAPICHECK COVID-19 Ag
Manufactured by M.I.Tech Co. Ltd., South Korea - www.mitech.co.kr
Device identification number
2928
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Rhinovirus, SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Expiration date : 18 months
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Quantitative
Time
15 minutes
LOD
15.6 PFU/mL
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
4 AU
False negatives
1 AU
Precision
Not evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 %
Clinical Specificity
99 %
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