LOMINA SARS-CoV-2 N-Protein Antigen Rapid Test
Manufactured by Lomina Superbio a.s., Czechia - www.lomina.ch
Device identification number
2158
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Semi-automated
Physical Support
Cassette
Target type
Antigen
Specimen
Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The test kit is intended for the qualitative detection of the new Nucleocapsid (N) antigen of the coronavirus SARS-CoV-2 in human oropharyngeal swab samples in vitro. It is used as an additional early detection indicator for suspected cases of nucleic acid detection, or is used in conjunction with the detection of nucleic acid in the diagnosis of suspected cases of COVID19. It cannot be used as a main test to diagnose and rule out pneumonitis caused by a new coronavirus. Limit of detection (LOD): 20 TCID 50ml/(CT>38)
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
20 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 %
False negatives
2 %
Precision
Evaluated
Accuracy
95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90 %
Clinical Specificity
97 %
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