SARS-CoV-2 Antigen Rapid Testing kit(Colloidal Gold)
Manufactured by Guangzhou Yunrui Medical Technology Co. Ltd., China - https://jrui.onesite.alibaba.com/
Device identification number
2904
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Antigen
Specimen
Anterior nasal swab, Mid-turbinates swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The SARS-CoV-2 Antigen Rapid Testing kit(Colloidal Gold)of Guangzhou Yunrui Medical Technology Co., Ltd is a colloidal gold immunochromatography assay, intended for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal swab (NPS), oropharyngeal swab (OPS) and saliva specimens from individuals suspended SARS-CoV-2 infection patients. It is suitable for the pathogen examination for suspected novel coronavirus- induced pneumonia (COVID-19) patients.
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Subcategory
Validity test kit
Method
ELISA
Measurement
Qualitative
Time
15 minutes
Subclass
Microtiter
Detection Principle
Colloidal gold
LOD
0.3 ng/mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
Results are for reference only and cannot be used as the sole criterion for clinical diagnosis
False negatives
Due to methodological limitations, low virus burden in a specimen may lead to false negative resul
Precision
Evaluated
Accuracy
98.77 % (95% CI:95.61%-99.85%)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.28 % (95%CI:90.76%-99.96%)
Clinical Specificity
99.04 % (95% CI: 94.76%-99.98%)
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