Saliva Orawell Covid_19 Ag
Manufactured by Jiangsu Well Biotech Co. Ltd., China - https://www.wellbioscience.com/
Device identification number
2490
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC, Semi-automated
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, 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.36, 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
Il test è costruito a ciclo chiuso antiadulterante del prelievo, con flacone reagente predisposto all'inserimento del tamponcino_prelievo e utilizzabile come contagocce( senza trasferimento o travasi del prelievo)
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Other ()
LOD
25 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.85 % (1 su 35)
False negatives
0 % 0 su 200
Precision
Evaluated
Accuracy
99.57 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.1 %
Clinical Specificity
99 %
Type of antigen
Nucleocapsid protein
Notes
Rapid test Device- CO-03 . registrato come DM n. 2015988/r al Portale DM del Ministero della Salute
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