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

COVID-19 In Vitro Diagnostic Medical Device - detail

Atila iAMP COVID-19 SANO Assay

Manufactured by Atila BioSystems, Inc, United States - https://atilabiosystems.com/ 

Device identification number
2184
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Microplate
Target
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, SARS-CoV
Commercial Status
Commercialised
Last Update
2021-06-07 09:15:15 CET
Comments
iAMP COVID-19 SANO Assay is a real-time fluorescent RT-isothermal assay based on Atila’s proprietary isothermal amplification technology intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs and saliva specimens from individuals with signs and symptoms of infection who are suspected of COVID-19.
Assay Type
Nucleic acid-Other
Method
LAMP
Measurement
Qualitative
Time
70 minutes
Detection Principle
Fluorescence
LOD
AU 2.5
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
0 %
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
Clinical Specificity
100 %

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