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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Antigen Rapid Test (Nasal Swab)

Manufactured by Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd., China

Device identification number
3622
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV
Pathogens detected
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Hemophilus Influenzae, Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV
Lineages detected
B.1.1.529 (Omicron)
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
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
N.A.
Detection Principle
Colloidal gold
LOD
115 TCID50/ml
Analytical Sensitivity
96 %
Analytical Specificity
99.6 %
False positives
96 %
False negatives
99.6 %
Accuracy
98.1 %
Clinical Sensitivity
96 %
Clinical Specificity
99.6 %

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