LUCA NK COVID-19 Ag LLB
Manufactured by LUCA AICELL Inc., South Korea - http://lucaaicell.com/
Device identification number
2654
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Regarding your question on the swabs, there is no distinction between nasal and nasopharyngeal. Our swabs can be used for both nasal and nasopharyngeal. Therefore, we have included only 25 swabs. Does this clarify your question?
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
2 ng/mL (Nucleocapsid protein recombinant antigen)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
3 %
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
95 % (Antigen)
Clinical Specificity
100 % (Antigen)
Type of antigen
Nucleocapsid protein
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