New Coronavirus (COVID-19) Antigen Rapid Test (saliva)
Manufactured by Anhui Formaster Biosci Co. Ltd., China - www.for-master.com
Device identification number
2480
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
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
no
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Time
20 minutes
Subclass
Sandwich, Double
LOD
1250 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.02 %
False negatives
3.76 %
Precision
Evaluated
Accuracy
98.81 % ( (Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.24 % ( (Antigen))
Clinical Specificity
99.8 % ( (Antigen))
Type of antigen
Nucleoprotein
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