COVID-19 Antigen Rapid Test
Manufactured by Beijing O&D Biotech Co. Ltd., China - http://www.odbio.com/
Device identification number
2494
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Epstein-Barr Virus (EBV), Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
COVID-19 Antigen Rapid Test is used for detection of COVID-19 specific antigens in human Nasal and Oropharyngeal Swab samples. It only detects the N protein and can’t detect the S protein and its mutation structure.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.33 % (For Nasal Swab Sample -(4/300);)
False positives
0.67 % (For Nasopharyngeal Swab Sample - (2/300))
False positives
1 % (For Oropharyngeal Swab Sample - (3/300); )
False negatives
6.09 % (For Nasopharyngeal Swab Sample - (7/115))
False negatives
6.96 % (For Oropharyngeal Swab Sample - (8/115); )
False negatives
7.83 % (For Nasal Swab Sample - (9/115); )
Precision
Evaluated
Accuracy
96.87 % (For Nasal Swab Sample)
Accuracy
97.35 %
Accuracy
97.83 % (For Nasopharyngeal Swab Sample)
Accuracy
97.35 % (For Oropharyngeal Swab Sample)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.17 % (For Nasal Swab Sample - (95% CI: 85.26%-96.13% ))
Clinical Sensitivity
93.04 % (For Oropharyngeal Swab Sample - (95% CI: 86.33%-96.73% ))
Clinical Sensitivity
93.91 % (For Nasopharyngeal Swab Sample - (95% CI: 87.86%-97.52% ))
Clinical Specificity
98.67 % (For Nasal Swab Sample - (95% CI: 96.39%-99.57%); )
Clinical Specificity
99 % (For Oropharyngeal Swab Sample - (95% CI: 96.86%-99.74%); )
Clinical Specificity
99.33 % (For Nasopharyngeal Swab Sample - (95% CI: 97.61%-99.92%))
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