sanity 2.0 system
Manufactured by Xiamen Zeesan Biotech Co. Ltd., China - http://www.zeesandx.com/
Device identification number
3074
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Target type
Nucleic acid
Targets
ORF1ab polyprotein/gene
Specimen
Bronchoalveolar lavage fluid, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum
Cross-reactivity (pathogens tested)
Epstein-Barr Virus (EBV)
Pathogens detected
Coronaviruses (HCoV)
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Based on the principle of real-time PCR detection, the product is used together with supporting testing reagents for clinical qualitative detection of target nucleic acids (DNA / RNA) from human samples, including pathogens and human genes.
Assay Type
Nucleic acid-PCR
Self Test
Yes
Method
RT-PCR
Measurement
Qualitative
Time
75 minutes
LOD
500 AU
Positive control
14 AU
Negative control
82 AU
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
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