Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography)
Manufactured by Zhejiang Gene Science Co., Ltd, China - http://www.gene-science.com/
Device identification number
2557
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Card, Lateral flow, Latex, Strip
Target
Antigen
Specimen
Deep (cough) sputum, Nasopharyngeal swab, Oropharyngeal swab
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, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2021-08-20 09:27:31 CET
Comments
None
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
180 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
1.27 %
Fn
5.42 %
Precision
Evaluated
Accuracy
96.81 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.58 %
Clinical Specificity
98.73 %
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