COVID-19 IgM/IgG Rapid Test Kit
Manufactured by Shenzhen Dakewe Bio-engineering Co. Ltd., China - www.dakewe.com
Device identification number
1998
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
[Reagents and Materials Provided] COVID-19 IgM/IgG Rapid Test (20 each) Foil pouched test device containing one test strip which is encased in plastic device cassette, one pipette for blood transfer, and one piece of desiccants. Buffer Vial (1 each) The buffer vial contains 10ml phosphate buffered saline (PBS) for sample dilution. Package Insert (1 each) Instructions for use.
Assay Type
Immuno-Antibody
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
0 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.92 % ((7/364))
False negatives
6.12 % ((15/245))
Precision
Evaluated
Accuracy
96.4 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
93.9 %
Clinical Specificity
98.1 %
Type of antigen
Other
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