ACCEL ELISA COVID-19 kit
Manufactured by Plexense Inc., South Korea - www.plexense.com
Device identification number
2005
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Semi-automated
Physical Support
Microplate
Target type
Antibody, IgA, IgG, IgM
Specimen
Plasma
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Calculate positive and negative results by dividing each sample’s or control’s reaction value at OD 650 nm by the cutoff value determined during the assay procedure. The cut-off value is determined by + 3 SD from the average OD of triplicated negative controls.
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
N.A.
Method
ELISA
Measurement
Qualitative
Time
45 minutes
Subclass
Enzyme-linked
LOD
4.3 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
1 AU
Precision
Evaluated
Accuracy
98.5 % ((IgG,IgM,IgA))
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
98 % ((IgG,IgM,IgA))
Clinical Specificity
99 % ((IgG,IgM,IgA))
Type of antigen
Nucleoprotein
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