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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Test Kit (DryColorLatex Immunoassay)

Manufactured by Lansion Biotechnology Co., Ltd., China - en.lansionbio.com 

Device identification number
2818
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Latex
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1 B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
The product is intended for the qualitative detection of nucleocapsid protein antigen from SARS- CoV-2 in direct nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms.Antigens are generally detectable in nasopharyngeal specimens during the acute phase of infection.COVID-19 is an acute respiratory infectious disease that is highly susceptible to human infection.Currently, the patients infected by the novel coronavirus are the main source of infection,asymptomatic infected people can also bean infectious source.Based on the current epidemiological investigation, the incubation period for COVID-19 ranges from 1 to 14 days,with most cases ranging from 3 to 7days,the main manifestations include fever,fatigue,and dry cough.Nasal congestion,runny nose,sore throat,myalgia, and diarrhea are
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Quantitative
Time
15 minutes
Detection Principle
Colorimetry
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1 AU
Fn
2 AU
Precision
Evaluated
Accuracy
95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 %
Clinical Specificity
99.9 %
Type of antigen
Spike 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