COVID-19 Antigen Mircrofluidic Chip
Manufactured by NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen), China - www.newscen.com
Device identification number
2820
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Semi-automated
Physical Support
Chip
Target type
Antigen
Specimen
Nasal swab, Saliva, Throat swab
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
For more information , please contact with us via our email address : anna.int@newscen.com
Assay Type
Immuno-Antigen
Method
Immunoassay
Time
4 minutes
LOD
2.5 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 AU
False negatives
0 AU
Precision
Evaluated
Accuracy
99.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.8 %
Clinical Specificity
99.8 %
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