Lomina SARS-CoV-2 Antigen LTX test
Manufactured by Lomina Superbio a.s., Czechia - www.lomina.ch
Device identification number
2560
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Latex
Target type
Antigen
Antibody type
Polyclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.526 (Iota), B.1.526.1, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-12-07 08:49:13 CET
Comments
The kit is used for the qualitative detection of new coronavirus nucleocapsid (N) antigen in human nasal swab samples in vitro. It is used as a supplementary detection indicator for suspected cases of new coronavirus.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Immunofluorescence
LOD
30000 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
% Of the 320 negativve samples, 0 were false positive
False negatives
2.3 % (Of the 130 positive samples, 3 were false negative)
Precision
Evaluated
Accuracy
99.33 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.7 %
Clinical Specificity
99.9 % (>99.9%)
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