SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA)
Manufactured by Jiangsu Medomics Medical Technology Co., Ltd, China - www.medomics-dx.com
Device identification number
3974
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior 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), 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，Staphylococcus epidermidis，Bordetella pertussis，Legionella pneumophila，Streptococcus pneumoniae，Candida albicans), Parainfluenza Virus Type 1, Respiratory Syncytial V (RSV), SARS-CoV
Pathogens detected
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, Other (Influenza A H7N9)
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), 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
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
10 TCID50/ml
Analytical Sensitivity
86.46 %
Analytical Specificity
100 %
False positives
0 %
False negatives
13.54 %
Accuracy
97.8 %
Clinical Sensitivity
86.46 %
Clinical Specificity
100 %
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