ASAPath COVID-19 Antigen Rapid Test
Manufactured by Microgenics Corporation, United States - www.thermofisher.com
Device identification number
2179
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Anterior nasal swab, Nasal swab
Pathogens detected
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2021-06-04 02:30:04 CET
Comments
Subclass: Enzyme-linked and Sandwich. Limit of detection (LOD): 2237 TCID50/mL (heat-inactivated virus).
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
30 minutes
Subclass
Enzyme-linked
LOD
2237 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 % Zero false positives.
Fn
6 AU (Six false negatives)
Precision
Evaluated
Accuracy
95.1 % ( (Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
80.6 % ( (Antigen))
Clinical Specificity
100 % ( (Antigen))
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