SARS-CoV-2 antigen Test Kit (LFIA)
Manufactured by Jiangsu Medomics medical technology Co. Ltd., China - https://www.medomics-dx.net/
Device identification number
2006
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Card, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasopharyngeal swab, Throat 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), Hemophilus Influenzae, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (Influenza A H7N9，Enterovirus CA16e，Staphylococcus aureus，Candida albicansLegionella pneumophila，Staphylococcus epidermidis，Bordetella pertussis，Streptococcus pneumoniae，), Parainfluenza Virus Type 1, Respiratory Syncytial V (RSV), SARS-CoV
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.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-10-12 05:48:07 CET
Comments
Medomics SARS-CoV-2 antigen Test Kit(LFIA) is used to qualitatively detect SARS-CoV-2 in human samples in vitro. Medomics SARS-CoV-2 antigen Test Kit(LFIA) detects the SARS-CoV-2 nucleocapsid antigens with colloidal gold immunochromatography using a double antibody sandwich assay.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
10 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
9.64 %
Precision
Evaluated
Accuracy
98.9 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
90.36 %
Clinical Specificity
100 %
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