PCL COVID19 Ag Gold
Manufactured by PCL Inc., South Korea - www.pclchip.com/
Device identification number
2243
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, Mumps Virus (MuV), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus
Pathogens detected
SARS-CoV-2
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.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 03:42:41 CET
Comments
Compatible with Saliva specimen, NP Swab Specimen & Nasal Specimen
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
562 TCID50/ml
Calibration
Evaluated
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
9.7 %
Precision
Evaluated
Accuracy
97.52 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90.83 % (Antigen)
Clinical Specificity
99.5 % (Antigen)
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