Biomerica COVID-19 IgG/IgM Rapid Test (1507A)
Manufactured by Biomerica Inc., United States - biomerica.com/index.asp
Device identification number
1601
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antibody, IgG, IgM
Targets
nucleocapsid protein
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
data available upon request (LOD=0)
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
4 AU
False negatives
0 AU
Precision
Evaluated
Accuracy
96 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
Type of antigen
nucleoprotein
Notes
Rapid diagnostic test lateral flow
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