SARS-oV- Antigen Rapid Test kit (Saliva Test)
Manufactured by Ningbo Home Test Bio-echnology Co. Ltd., China - http://www.nbhtbio.cn/List-how1-d-01.html
Device identification number
2021
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge, Lateral flow, Strip
Target type
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The product has passed the PEI review.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other ()
Method
Chromatography
Measurement
Qualitative
Time
15 minutes
LOD
500 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
4 AU
False negatives
5 AU
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
97.92 %
Clinical Specificity
98.34 %
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