Novel Coronavirus (2019-nCoV) Antigen Test Kit (Latex Method)
Manufactured by Glallergen Co. Ltd. - www.glallergen.com
Device identification number
4064
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
non-structural protein NSP1, non-structural protein NSP10, non-structural protein NSP12, non-structural protein NSP13, non-structural protein NSP14, non-structural protein NSP15, non-structural protein NSP16, non-structural protein NSP2, non-structural protein NSP3, non-structural protein NSP4, non-structural protein NSP5, non-structural protein NSP6, non-structural protein NSP7, non-structural protein NSP8, non-structural protein NSP9, nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, 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, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
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
2022-09-29 09:07:46 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
N.A.
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
9.65 TCID50/ml
Calibration
Evaluated
Analytical Sensitivity
94.44 %
Analytical Specificity
99.02 %
Analysis of cross reactivity
Evaluated
False positives
0.66 %
False negatives
6.94 %
Precision
Evaluated
Accuracy
96.53 %
Robustness
Evaluated
Clinical Sensitivity
93.06 %
Clinical Specificity
99.34 %
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