SARS-CoV-2 Antigen Test Kit
Manufactured by Alphagen Bio-Technology Co.,Ltd, China - http://www.alphagen-bio.com/
Device identification number
3965
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Hemophilus Influenzae, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Rhinovirus
Pathogens detected
SARS-CoV
Information on antigen epitope targeted by the antibodies used in the design of the device
The input of epitope is 234-419aa.
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), Other (omicron B 1, B, 2, B 4, B 5), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
In development
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
N.A.
Time
15 minutes
Subclass
N.A.
Detection Principle
Colloidal gold
LOD
250 TCID50/ml
Analytical Sensitivity
97 %
Analytical Specificity
100 %
False positives
0.01 %
False negatives
0.13 %
Accuracy
95 %
Clinical Sensitivity
87 %
Clinical Specificity
98 %
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