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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 (Colloidal Gold Method)

Manufactured by Biohit Healthcare (Hefei) Co.,Ltd., China - www.biohit.cn 

Device identification number
2230
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Anterior nasal swab
Pathogens detected
Adenovirus, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, MERS-CoV, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Varicella Zoster Virus (VZV)
Commercial Status
Commercialised
Last Update
2021-12-08 06:33:39 CET
Comments
This rapid kit is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen (hereinafter referred to as SARS-CoV-2 N-antigen) in anterior nasal swab samples.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Sample preparation
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
200 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
5 AU
Fn
1 AU
Precision
Evaluated
Accuracy
100 % ( (Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.12 %
Clinical Specificity
99.49 %
Type of antigen
Nucleoprotein

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