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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 Ag Rapid Test (self-test)

Manufactured by AUTOBIO DIAGNOSTICS. Ltd., China - https://www.autobio.com.cn/ 

Device identification number
3082
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Influenza A, Influenza B, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
Chlamydia Pneumoniae, Hemophilus Influenzae, Human Metapneumovirus (HMPV), Mycoplasma Pneumoniae
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This assay is based on a colloidal gold method for the rapid, qualitative determination of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) nucleocapsid protein antigen in anterior nasal swab specimens. This test kit is intended for self-testing at home for individuals with symptoms of SARS-CoV-2 infection. This test kit shall not be used as a sole basis to diagnose or exclude SARS-CoV-2 infection.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Method
Immunoassay
Time
15 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
5.45 %
False negatives
0 %
Precision
Evaluated
Accuracy
98.94 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.55 %
Clinical Specificity
100 %
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