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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

GB COVID-19 Ag POCT

Manufactured by General Biologicals Corporation, Taiwan ROC - www.gbc.com.tw/ 

Device identification number
4081
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV, SARS-CoV-2
Pathogens detected
SARS-CoV, SARS-CoV-2
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
There are two Anti-2019-nCoV Antibodies used in the kits. The Clone ID are 8C1 and 5F6. The 8C1 is coupled with colloidal gold. It is used as a conjugated colloidal gold antibody to detect the SARS-CoV-2 nucleocapsid protein (N protein) bound to the test strip. The Related Antigen Epitope Sequence of 8C1 was PSDSTGSNQNGERSGARSKQRRPQGLPN. The 5F6 This antibody is sprayed on the Test Line to bind the SARS-CoV-2 nucleocapsid protein (N protein) of the sample. The Related Antigen Epitope Sequence of 5F6 was GSRGGSQASSRSSSRSRNSSRNSTPGSS.
Lineages detected
B.1.1.529 (Omicron), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-09-20 02:54:12 CET
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
Detection Principle
Colloidal gold
LOD
100 TCID50/ml
Calibration
Evaluated
Analytical Sensitivity
84 %
Analytical Specificity
98.14 %
Analysis of cross reactivity
Evaluated
False positives
1.8 %
False negatives
16 %
Precision
Not evaluated
Accuracy
94.8 %
Robustness
Evaluated
Clinical Sensitivity
84 %
Clinical Specificity
98.14 %

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