COVID-19 Antigen Rapid Test Cassette(Oral Fluid)
Manufactured by Hangzhou Biotest Biotech Co. Ltd., China - en.biotests.com.cn
Device identification number
1878
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
A rapid test for the qualitative detection of COVID-19 antigen in oral fluid.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
0
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 324 negative samples are confirmed by RT-PCR and tested, no false positive result is observed.
False negatives
5 % (2 false negative results are observed in 40 positive samples confirmed by RT-PCR)
Precision
Evaluated
Accuracy
99.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95 %
Clinical Specificity
100 %
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