RAPID GOLD PRO CoV-2 AG Test
Manufactured by VivaChek Biotech (Hangzhou) Co. Ltd., China - www.vivachek.com
Device identification number
3133
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, 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, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A, Influenza A H3N2, Influenza A H5N1, MERS-CoV, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Rapid Gold Pro CoV-2 Ag Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab, oropharyngeal swab or nasopharyngeal swab specimen.
Assay Type
Immuno-Antigen
Self Test
N.A.
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
75.5 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.62 % (Nasal swab)
False positives
0.01 % (Oropharyngeal swab)
False positives
0.32 % (Nasopharyngeal swab)
False negatives
1.24 % (Nasal swab)
False negatives
0.65 % (Oropharyngeal swab)
False negatives
0.63 % (Nasopharyngeal swab)
Precision
Evaluated
Accuracy
99.78 % (Oropharyngeal swab)
Accuracy
99.17 % (Nasal swab)
Accuracy
99.58 % (Nasopharyngeal swab)
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
99.37 % (Nasopharyngeal swab)
Clinical Sensitivity
99.35 % (Oropharyngeal swab)
Clinical Sensitivity
98.76 % (Nasal swab)
Clinical Specificity
99.68 % (Nasopharyngeal swab)
Clinical Specificity
99.99 % (Oropharyngeal swab)
Clinical Specificity
99.38 % (Nasal swab)
Type of antigen
Nucleocapsid protein
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