COVID-19 IgG/IgM Rapid Test Cassette
Manufactured by Hangzhou Sejoy Electronics & Instruments Co. Ltd., China - sejoy.com/
Device identification number
1970
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 with anti-coagulants
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
We have evulated the relative interference substances.
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
40 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % IgG
False positives
2 % IgM
False negatives
0 AU
False negatives
9 % IgM
Precision
Evaluated
Accuracy
100 % IgG
Accuracy
93.33 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
88.61 % IgM
Clinical Specificity
100 % IgG
Clinical Specificity
97.67 % IgM
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