2019-nCoV Ag Test (Latex Chromatography Assay)
Manufactured by Innovita Biological Technology, China - www.innovita.com.cn/
Device identification number
1994
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Other
Target
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
0 %
Precision
Evaluated
Accuracy
98.7 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.7 %
Clinical Specificity
100 %
Type of antigen
Nucleoprotein
Notes
Latex chromatography assay
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