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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SPESERA Covid-19 Antibody Neutralizing Rapid Test Cassette

Manufactured by SPESERA SAÄžLIK ÃœRÃœNLERÄ° İÇ VE DIÅž Ltd. ÅžTÄ°., Turkey - www.spesera.com.tr 

Device identification number
2615
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG
Specimen
Plasma, Serum, Whole blood, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
www.spesera.com.tr
Assay Type
Immuno-Antibody
Self Test
Yes
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
580 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.19 % (4/335)
False negatives
0.81 % (3/366)
Precision
Evaluated
Accuracy
99.01 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.2 %
Clinical Specificity
99.17 %
Type of antigen
Other

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