Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

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
2022-03-14 09:42:40 CET
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