Novel Coronavirus (COVID-19) Antigen Testkit (Colloidal Gold
Manufactured by Hangzhou Laihe Biotech Co. Ltd., China - www.lyherbio.com
Device identification number
2224
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), 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, P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
In case of questions kindly do not hesitate to contact us.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
135
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
10% prevalence, no more than 0,1%
False negatives
10% prevalence, no more than 5,0%
Precision
Evaluated
Accuracy
97 % ((96% to 98%))
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
95 ((>95%))
Clinical Specificity
98 ((>98%))
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