Skip to main content
European Commission logo
Live, work, travel in the EU
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Previous
Next

EasyNAT COVID-19 RNA Test

Manufactured by Ustar Biotechnologies (Hangzhou) Ltd., China - en.bioustar.com 

Device identification number
3135
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Microplate
Target type
Nucleic acid
Targets
nucleocapsid protein/gene, ORF1ab polyprotein/gene
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta),
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The product was approved by Notify Body POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. on April 22, 2022 (Fig. CE1434). The EasyNAT COVID-19 RNA Test meets the applicable provisions of the EU Directive 98/79/EC on in vitro diagnostic medical devices for self-testing accordingly classes, and carry the CE1434 mark accordingly.
Assay Type
Nucleic acid-Other
Self Test
Yes
Reader Required
No
Method
Other ()
Measurement
Qualitative
Time
35 minutes
LOD
3000 cpm
Positive control
6 AU
Negative control
10 AU
Clinical Sensitivity
95.413 %
Clinical Specificity
99.803 %
Throughput
Single cartridges

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