COVID-19 Antigen Detection Kit (Colloidal Gold)
Manufactured by Zhuhai Lituo Biotechnology Co. Ltd., China - www.lituo.com.cn
Device identification number
2304
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The test kit is approved for professional use as in-vitro daignostic device and adopts the double antibody sandwich method to qualitative detect noval coronavirus antigens in human nasopharyngeal swab, oropharyngeal swab specimens.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Capture
Detection Principle
Colloidal gold
LOD
428 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.53 % ( 1 of 189 (99.47% specificity))
False negatives
4.04 % ( 9 of 223 (95.96% sensitivity))
Precision
Evaluated
Accuracy
98.06 % ( (Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.96 % ((Antigen))
Clinical Specificity
99.47 % ((Antigen))
Type of antigen
Nucleorotein
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