2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography)
Manufactured by Guangdong Longsee Biomedical Co. Ltd., China - www.longseemed.com
Device identification number
1216
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cartridge, Strip
Target type
Antigen
Antibody type
Monoclonal
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 HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (Candida albicans, Legionella pneumophila, Streptococcus pyogenes, Streptococcus pneumoniae, Staphylococcus aureus, Staphylococcus epidermidis), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
A.23.1, 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.37 (Lambda), Other (BA.2,BJ.1,BA.2.12.1,BA.2.75,BA.4,BA.5,BF.7), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-10-12 09:45:49 CET
Comments
This update is mainly for vaviants detected.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
600 TCID50/ml (Oropharyngeal swab)
LOD
600 TCID50/ml (Nasal swab)
LOD
600 TCID50/ml (Nasopharyngeal swab)
Analysis of cross reactivity
Evaluated
False positives
0.28 % (Nasopharyngeal swab)
False positives
0.32 % (Nasal swab)
False positives
0.28 % (Oropharyngeal swab)
False negatives
4.49 % (Nasopharyngeal swab)
False negatives
5.85 % (Nasal swab)
False negatives
4.78 % (Oropharyngeal swab)
Precision
Evaluated
Accuracy
97.64 % (Nasopharyngeal swab)
Accuracy
97.6 % (Nasal swab)
Accuracy
97.5 % (Oropharyngeal swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.51 % (Nasopharyngeal swab)
Clinical Sensitivity
95.22 % (Oropharyngeal swab)
Clinical Sensitivity
94.15 % (Nasal swab)
Clinical Specificity
99.72 % (Nasopharyngeal swab)
Clinical Specificity
99.72 % (Oropharyngeal swab)
Clinical Specificity
99.68 % (Nasal swab)
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