ACCEL ELISA COVID-19 Saliva Antigen Kit
Manufactured by Plexense Inc., South Korea - www.plexense.com
Device identification number
2378
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Microplate
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
LoD: 2.07x10^3(TCID50/mL) Calculate positive and negative results by dividing each sample’s or control’s reaction value at OD 450 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-Antigen
Reader Required
Yes
Subcategory
Sample preparation
Method
ELISA
Measurement
Qualitative
Time
95 minutes
Subclass
Enzyme-linked
LOD
2.07 TCID50/ml (x10^3)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
2 AU
Precision
Evaluated
Accuracy
94.83 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.67 %
Clinical Specificity
97.06 %
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