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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



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
2022-04-20 12:09:38 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
Crossreactivity
Evaluated
Fp
0.55 %
Fn
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