POCT Immunoassay System - HP-083/4
Manufactured by Shijiazhuang Hipro Biotechnology Co. Ltd., China - www.hipro.us
Device identification number
1094
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Semi-automated
Physical Support
Latex
Target type
Antigen, IgG
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 registered in 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
92 %
Clinical Specificity
97 %
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