SARS-CoV-2 Antigen Test Kit (Colloidal Gold)
Manufactured by Genrui Biotech Inc., China - www.genrui-bio.com
Device identification number
2012
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)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Influenza A, Influenza B, MERS-CoV, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus
Lineages detected
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
PEI Evaluation: Positive
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
180 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.98 %
False negatives
8.85 %
Precision
Evaluated
Accuracy
94.88 % (Nasal Swab)
Accuracy
97.15 % (NP Swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.15 % (Nasal Swab)
Clinical Sensitivity
95.03 % (NP Swab)
Clinical Specificity
99.02 % (Nasal Swab)
Clinical Specificity
99.02 % (NP Swab)
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