SARS-COV-2 Antigen Rapid Test Kit
Manufactured by Jiangsu Baozhilin Medical Technology Co. Ltd., China
Device identification number
2821
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Fully automated (robot), Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Throat secretion, Throat swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Novel Coronavirus antigen rapid detection reagent is an effective early screening and diagnostic index of novel Coronavirus infection, which is an effective complement to the false positive of COVID-19 nucleic acid test. Rapid detection within 15 minutes with a nasopharyngeal test paper, the reagents can be stored at room temperature and transported, which is a great boon to the medical community.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Analytical Sensitivity
91 %
Analytical Specificity
97 %
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