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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

GenBody COVID-19 Ag

Manufactured by GenBody Inc., South Korea - www.genbody.co.kr 

Device identification number
1244
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus A, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.526 (Iota), B.1.617.2 (Delta), P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
507 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.91 % (3/103)
False negatives
0 % 0/301
Precision
Evaluated
Accuracy
99.26 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.09 %
Clinical Specificity
100 %
Type of antigen
Nucleocapsid protein
Notes
antigen_epi Clone #2F4 for gold dye, Clone #3C3 for capture(membrane). Based on the Epitope Mapping Results, the target epitope is presented below; (Reference: NCBI Reference Sequence ID: NC_045512.2, Domain CDS 28274 to 29533; Nucleocapsid phosphoprotein) 1) Clone #2F4 258P, 260Q, 261K, 262R, 263T, 264A. 265T, 266K, 269N, 273A, 286F, 294Q, 296T, 297D, 298Y, 302P, 305A, 306Q, 311A, 312S, 313A, 316G, 335G, 340D, 343D, 356H 2) Clone #3C3 3D, 114G, 262R, 264A, 322M, 323E, 324V, 325T, 326P, 329T, 335G, 340D, 346F, 348D, 350V, 355K, 365P -Conclusion Both #2F4 and #3C3 recognize conformational epitope as below; #2F4 : PQKRTTKNAQTDYPAQASAGGDDH #3C3 : DGRAMEVTPTGDFDVKP

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