SARS-CoV-2 Antigen Rapid Test Kit - Saliva (Colloidal Gold)
Manufactured by JOYSBIO (Tianjin) Biotechnology Co. Ltd., China - en.joysbio.com/
Device identification number
1766
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
320 U/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 0 out of 260 RT-PCR negative specimens
False negatives
4.9 % (5 out of 102 RT-PCR positive specimens)
Precision
Evaluated
Accuracy
98.62 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.1 %
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