SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold )
Manufactured by ISO13485, China - https://www.lsybt.com/En/
Device identification number
2138
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal 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.1.526.2, 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
In vitro qualitative detection of SARS-CoV-2 nucleocapsid antigen in swab specimen within the first 5-7 days after onset of COVID-19 symptoms
Assay Type
Immuno-Antigen
Method
Immunochromatography
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
400 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 % ((≤1%))
False negatives
5 % ((≥95%))
Precision
Evaluated
Accuracy
99.68 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.14 %
Clinical Specificity
100 %
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