Foresight SARS-CoV-2 IgM EIA Test Kit
Manufactured by ACON Laboratories Inc., United States - www.aconlabs.com
Device identification number
1672
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
30 minutes
Subclass
Other ()
LOD
1 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
97.72 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90.14 %
Notes
Manual or automated 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