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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay)

Manufactured by PerGrande BioTech Development Co. Ltd., China - www.pergrande.com.cn 

Device identification number
2116
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Please review, thanks.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
20 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.89 %
False negatives
5.72 %
Precision
Evaluated
Accuracy
96.41 % (( 95.24%-97.30%)(Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.28 % (( 92.33%-95.76% )(Antigen))
Clinical Specificity
99.11 % (( 97.94%-99.62%)(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