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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Anti-SARS-CoV-2 Rapid Test

Manufactured by Autobio Diagnostics Co., Ltd, China - https://www.autobio.com.cn/ 

Device identification number
665
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Cassette, Strip
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-06-18 12:36:14 CET
Comments
This assay is based on a colloidal gold method for the rapid, qualitative determination of Anti-SARS-CoV-2 (IgG/IgM antibodies of Severe Acute Respiratory Syndrome Coronavirus 2) in human serum, plasma or whole blood. IgM Positive Percent Agreement of Anti-SARS-CoV-2 Rapid Test was 85.43% (346/405), (95%CI: 81.7% - 88.5%), IgM Negative Percent Agreement was 99.68% (311/312), (95%CI: 98.2% - 99.9%). IgG Positive Percent Agreement of Anti-SARS-CoV-2 Rapid Test was 86.17% (349/405), (95%CI: 82.5% - 89.2%), IgG Negative Percent Agreement was 99.36% (310/312), (95%CI: 97.7% - 99.8%).
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
Detection Principle
Colloidal gold
Crossreactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
88.15 % ( (357/405) (95%CI: 84.6%-90.9%))
Clinical Specificity
99.04 % ( (309/312), (95%CI: 97.2%-99.7%))
Type of antigen
SARS-CoV-2 nucleocapsid

Related Scientific Literature

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