Suresign Professional 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood, Serum, Plasma))
Manufactured by CIGA Healthcare Ltd., United Kingdom - www.cigahealthcare.com/
Device identification number
1978
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
IgG, IgM
Specimen
Plasma, Saliva, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
the product was registered with the MHRA on 9th September 2020
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
LOD
2.5 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.6 %
False negatives
14 %
Precision
Evaluated
Accuracy
96.1 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
97.6 %
Clinical Specificity
95.9 %
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