SARS-CoV-2 Antigen Rapid Test
Manufactured by Qingdao Hightop Biotech Co. Ltd., China - www.hightopbio.com
Device identification number
1341
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal 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), Bordetella Pertussis, Enterovirus A71 (EV-A71), Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A, SARS-CoV
Pathogens detected
SARS-CoV
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Information on antigen epitope targeted by the antibodies used in the design of the device
SARS-CoV-2 monoclonal antibody1 is a linear epitope that recognizes NTD 44-55; SARS-CoV-2 monoclonal antibody2 is a conformational epitope that recognizes NTD 134-178.
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-11-17 09:51:03 CET
Comments
HIGHTOP SARS-COV-2 ANTIGEN RAPID TEST, CAN BE USED FOR SELF-TESTING AND FOR PROFESSIONAL TESTING, CONTACT FOR ORDERS ALLEN@HIGHTOPBIO.COM
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colorimetry
LOD
8 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
%
False negatives
1.96 %
Precision
Evaluated
Accuracy
99.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.04 %
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