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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Rapid Gold Pro SARS-CoV-2 AG Test

Manufactured by VivaChek Biotech (Hangzhou) Co. Ltd., China - www.vivachek.com 

Device identification number
3143
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-10-17 01:01:01 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
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
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