Novel Coronavirus(SARS-CoV-2) Nucleic Acid Detection Kit (Isothermal Amplification)
Manufactured by Shen Zhen Zi Jian Biotechnology Co. Ltd., China - http://www.szzijian.com/
Device identification number
2625
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Nucleic acid
Specimen
Bronchoalveolar lavage fluid, Nasopharyngeal swab, Oropharyngeal swab, Sputum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
http://www.szzijian.com/
Assay Type
Nucleic acid-Other
LOD
1000 copies/ml
Positive control
35 ct (≤35)
Negative control
UNDET or 40
Analytical Sensitivity
99 %
Analytical Specificity
100 %
Clinical Sensitivity
99 %
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