PocRoc®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
Manufactured by Lumigenex (Suzhou) Co. Ltd., China - http://www.lumigenex.com/
Device identification number
2128
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.616, C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The product PocRoc SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) was registered in Spain on 1st, Nov, 2020. We have sold millions of this product on the German market. Until now, there is no negative feedback from the market. After being listed by BfArM with AT455/20, the PocRoc SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) has positive results by PEI on Mar. 15,2021.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
121 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.84 %
False negatives
6.67 %
Precision
Evaluated
Accuracy
97.38 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.33 % ((Antigen))
Clinical Specificity
99.16 % ((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