COVID-19 IgG/IgM Rapid Test Dipstick
Manufactured by Acro Biotech Inc., United States - www.acrobiotech.com
Device identification number
1694
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Dipstick
Target type
Antibody, IgG, IgM
Specimen
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
10 minutes
LOD
0 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU ((IgG))
False positives
3 AU ((IgM))
False negatives
0.1 AU ((IgG))
False negatives
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