Automatic ImmunoAssay System - HP-AFS/1
Manufactured by Shijiazhuang Hipro Biotechnology Co. Ltd., China - www.hipro.us
Device identification number
1095
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Near POC / POC
Physical Support
Latex
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This product already registed on Netherlands.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Sample preparation
Method
Nephelometry
Measurement
Quantitative
Time
6 minutes
Subclass
Capture
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1
False negatives
1
Precision
Evaluated
Accuracy
90
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90
Clinical Specificity
95
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