COVID-19 IgG/IgM Rapid Test Dipstick
Manufactured by ACRO BIOTECH, Inc. - www.acrobiotech.com
Device identification number
1694
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Dipstick
Target
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
03/18/2021 09:03
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
0 AU
Calibration
not evaluated
Crossreactivity
evaluated
Fp
2 AU (IgG)
Fp
3 AU (IgM)
Fn
0.1 AU (IgG)
Fn
9.1 AU (IgM)
Precision
evaluated
Accuracy
98.4 % IgG
Accuracy
95.9 % IgM
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
99.9 % IgG
Clinical Sensitivity
90.9 % IgM
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