COVID-19 IgG/IgM Test Cassette (for Analyzer)
Manufactured by Acro Biotech Inc., United States - www.acrobiotech.com
Device identification number
1676
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
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
15 minutes
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
3.1 AU
False negatives
3.3 AU
Precision
Evaluated
Accuracy
96.9 % ((IgG, IgM))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.7 % ((IgG/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