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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



P4DETECT COVID-19 Ag

Manufactured by PRIME4DIA Co,. Ltd

Device identification number
321
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Bordetella Pertussis, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Influenza A H1N1, 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) Type A, Respiratory Syncytial V (RSV) Type B, SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.429 (Epsilon), B.1.617.2 (Delta), P.1 (Gamma), B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
P4DETECT COVID-19 Ag is a qualitative, lateral flow immunoassay for the detection of specific antigens Coronavirus in nasopharyngeal specimens. In this test, antibody specific to the SARS-CoV-2 antigen is separately coated on the test line regions of the test device. During testing, the extracted specimen reacts with the antibody to SARS-CoV-2 that are coated onto particles. The mixture migrates up the membrane to react with the antibody to SARS-CoV-2 on the membrane and generate one colored lines in the test regions. If SARS-CoV-2 antigens are present in the specimen a colored test line would be visible in the result window. If SARS-CoV-2 antigens are not present in the specimen, then no color appears in the test line.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Membrane-based
LOD
800 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 AU
Fn
3.3 AU
Precision
Evaluated
Accuracy
98.33 % (Antigen)
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.67 % (Antigen)
Clinical Specificity
100 % (Antigen)
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