COVISTIX COVID-19 VIRUS Rapid Antigen Detection Test
Manufactured by Zhengzhou Fortune Bioscience Co. Ltd., China - www.fortunetest.com
Device identification number
2009
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Manufactured for Sorrento Therapeutics, Inc. USA
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
LOD
0.01 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % None
False negatives
3.64 %
Precision
Evaluated
Accuracy
98.1 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.36 %
Clinical Specificity
100 %
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