NaorCov19
Manufactured by Rapid Diagnostic Systems Limited, Israel - www.naordia.com
Device identification number
2548
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cartridge, Dipstick
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, B.1.1.7 (Alpha), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
Rapid Saliva based molecular diagnostics, using an enhanced isothermal detection. Closed units with saliva collection and vials and container solution.
Assay Type
Unknown
Reader Required
No
Subcategory
Other ()
Method
LAMP
Measurement
Qualitative
Time
40 minutes
LOD
40 cpu
Positive control
Yes
Negative control
Yes
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
93.75 %
Clinical Specificity
99.95 %
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