2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) (Oropharyngeal swab)
Manufactured by Guangdong Longsee Biomedical Co. Ltd., China - http://www.longseemed.com/
Device identification number
2509
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge, Strip
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Rhinovirus, SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
1. Type of Antigen: Nucleocapsid protein (N protein); 2. PEI test is positive; 3. Approved and registered in Germany, Italy, Belgium, Autria, Peru, and so on.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Subcategory
Other ()
Method
Immunoassay
Time
15 minutes
Subclass
Sandwich, Double
LOD
600 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
19 AU
Precision
Evaluated
Accuracy
97.21 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.66 % ((Antigen))
Clinical Specificity
99.72 % ((Antigen))
Type of antigen
Nucleocapsid protein (N 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