SPESERA Covid-19 Antijen Hızlı Test Kaseti
Manufactured by Zhejiang Anji Saianfu Biotech Co. Ltd., China - http://www.seinofy.com
Device identification number
2553
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat secretion, Throat swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
http://www.seinofy.com
Assay Type
Immuno-Antigen
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
580 TCID50/ml
Positive control
98.34 % (100xTP/(TP+FP)=100x238/242=98,34%)
Negative control
98.51 % (100xTN/(FN+TN)=100x530/538=98.51%)
Analytical Sensitivity
93.76 %
Analytical Specificity
97.5 %
Clinical Sensitivity
96.89 %
Clinical Specificity
99.1 %
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