SARS-CoV-2 Antigen Test Kit (LFIA)
Manufactured by BioMedomics Inc., United States - www.biomedomics.com
Device identification number
2520
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Also tested versus a wide variety of endogenous and exogenous potential interferents and showed no interference at clinically relevants concentrations.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
2 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.49 % (2 out of 407 clinical specimens in clinical evaluation were false positives)
False negatives
2.27 % (5 out of 220 clinical specimens in clinical evaluation were false negatives)
Precision
Evaluated
Accuracy
98.88 % (antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.73 % (antigen)
Clinical Specificity
99.51 % (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