COVID-19 Antigen Rapid Test Kit(Saliva)
Manufactured by Safecare Biotech (Hangzhou) Co. Ltd., China - www.safecare.com.cn
Device identification number
1819
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
LOD: 0.25ng/ml, Ct <=30
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
0.25 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.55 %
False negatives
1.5 %
Precision
Evaluated
Accuracy
99.05 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.5 %
Clinical Specificity
99.45 %
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