COVID-19 Antigen Rapid Test
Manufactured by Shenzhen Everbest Machinery lndustry Co. Ltd., China - www.cem-instruments.com
Device identification number
3125
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card
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), Chlamydia Pneumoniae, Coronaviruses (HCoV), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Hepatitis A Virus (HAV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Rhinovirus, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay test for detection of the Nucleocapsid (N) Protein of SARS-CoV-2 virus and used for in vitro qualitative detection of SARS-CoV-2 antigen in human anterior nasal swab specimens.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
N.A.
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
494 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
SARS-coronavirus shows 90.52% homology across 100% of the nucleocapsid sequence.
False negatives
Negative test results are not intended to rule in other non-SARS viral or bacterial infections.
Precision
Evaluated
Accuracy
98.62 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.73 %
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