COVID19AgLTFLOW
Manufactured by LT Biotech JSC, Lithuania - www.ltbiotech.lt
Device identification number
2094
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Additional validation is performed in third party laboratory in 2021-12-03
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Sample preparation
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Enzyme-linked
LOD
50 µg
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
20 AU
Precision
Evaluated
Accuracy
98.12 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.01 %
Clinical Specificity
99.52 %
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