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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Coretests COVID-19 Ag Test

Manufactured by Core Technology Co. Ltd.

Device identification number
1919
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
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 H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (Enterovirus/Coxsackievirus B4, Influenza A H7N9, Legionella pnuemophila, Streptococcus pneumoniae, Streptococcus pyogenes (group A), Staphylococcus aureus, Staphylococcus epidermidis, Candida albicans), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus, SARS-CoV
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-10-31 09:12:45 CET
Comments
COVID-19 Ag Test is the chromatographic assay used for qualitative detection of the COVID-19 antigen in human nasopharyngeal swab / oropharyngeal swab / nasal swab specimen. This test kit uses COVID-19 monoclonal antibody and goat anti-mouse IgG polyclonal antibodies that are respectively immobilized on a nitrocellulose membrane. It uses colloidal gold to label sufficient COVID-19 monoclonal antibody, using nano-colloidal gold technology and applying highly specific antibody-antigen reaction and immunochromatographic analysis technology principle. When testing, the COVID-19 antigen in the sample combined with the colloidal gold-labeled COVID-19 monoclonal antibody to form a complex, which was then combined with the COVID-19 monoclonal antibody coated in the T line during chromatography, at this time there is one red line in the T area .When the samples do not contain COVID-19 antigen, colloidal gold-labeled COVID-19 monoclonal antibody cannot combined with COVID-19 monoclonal antibody in the T line region, so there is no red colored line in the T area. Regardless of the presence of COVID-19 antigen in the sample, a red line will form in the quality control area (C). The red line appears in the quality control area (C) serves as 1.verification that sufficient volume is added. 2.That proper flow is obtained 3. And as a control for the reagents.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
22.5 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
%
False negatives
18 %
Precision
Evaluated
Accuracy
91.09 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
82 %
Clinical Specificity
100 %
Type of antigen
Nucleoprotein

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