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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test

Manufactured by Qingdao Hightop Biotech Co., Ltd, China - www.hightopbio.com/ 

Device identification number
463
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Crossreactivity
Reported as not possible
Fp
Evaluated
Fn
Evaluated
Precision
Not Evaluated
Accuracy
92.8 % IgM
Accuracy
96 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
82 % IgM
Clinical Sensitivity
93 % IgG
Clinical Specificity
96 % IgM
Clinical Specificity
97 % IgG

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