Novel Corona- virus IgM/IgG Combo Rapid Test
Manufactured by Shenzhen Highcreation Technology Co. Ltd., China - www.hkrgr.com/
Device identification number
1345
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Targets
nucleocapsid protein
Specimen
Peripheral blood, Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0.1 AU
False positives
1 %
False negatives
1 %
Accuracy
98.1 % IgG
Accuracy
96.7 % IgM
Clinical Sensitivity
93 % IgG
Clinical Sensitivity
91.6 % IgM
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