COVID-19 Antibody Rapid Test Kit
Manufactured by Chongqing iSIA BIO-Technology Co. Ltd., China - www.isiabio.com.cn
Device identification number
1939
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Immunoassay
Time
15 minutes
LOD
0.8 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 %
Clinical Specificity
97 %
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