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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 Rapid Antigen Test (Colloidal Gold Method)

Manufactured by Sansure Biotech Inc., China - www.sansure.com.cn 

Device identification number
2097
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), 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) Type A, Rhinovirus
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
The SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) is intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein in human nasopharyngeal or nasal swab sampled from individuals suspected of COVID- 19.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
800 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1.6 %
Fn
1.9 %
Precision
Evaluated
Accuracy
98.2 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.4 %
Clinical Specificity
98.1 %
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