SARS-CoV-2 Antigen Test Kit (LFIA) Self-testing
Manufactured by Jiangsu Medomics medical technology Co. Ltd., China - https://www.medomics-dx.net/
Device identification number
2982
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
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, Hemophilus Influenzae, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Respiratory Syncytial V (RSV), SARS-CoV
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Hemophilus Influenzae, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Respiratory Syncytial V (RSV), SARS-CoV
Information on antigen epitope targeted by the antibodies used in the design of the device
The epitope recognized by the C00134 antibody is 79-88, and the epitope recognized by the C0035 antibody is 113-165.
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
2022-08-24 09:08:01 CET
Comments
SARS-CoV-2 Antigen Test Kit (LFIA) is a colloidal gold immunochromatography for the rapid qualitative detection of SARS-CoV-2 nucleocapsid antigens present in human anterior nasal samples in vitro. The test kit is designed for use as self-testing. This test kit is intended use for individuals by 18 or older with clinical symptoms of SARS-CoV-2 infection or who are suspected of COVID-19. If the suspected individual exhibits respiratory symptoms or suspected to be infected, it is recommended to combine PCR test, clinical symptoms, prevalence and further clinical data to confirm the diagnosis.
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
10 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
8.18 %
False negatives
0 %
Precision
Evaluated
Accuracy
98.41 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.82 % (Antigen)
Clinical Specificity
100 (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