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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 (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Analysis of cross reactivity
Reported as not possible
False positives
Evaluated
False negatives
Evaluated
Precision
Not evaluated
Accuracy
92.8 % IgM
Accuracy
96 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93 % IgG
Clinical Sensitivity
82 % IgM
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