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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



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
2022-04-20 12:09:38 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
Crossreactivity
Evaluated
Fp
1.33 % (For Nasal Swab Sample -(4/300);)
Fp
0.67 % (For Nasopharyngeal Swab Sample - (2/300))
Fp
1 % (For Oropharyngeal Swab Sample - (3/300); )
Fn
6.09 % (For Nasopharyngeal Swab Sample - (7/115))
Fn
6.96 % (For Oropharyngeal Swab Sample - (8/115); )
Fn
7.83 % (For Nasal Swab Sample - (9/115); )
Precision
Evaluated
Accuracy
97.35 %
Accuracy
96.87 % (For Nasal Swab Sample)
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