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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Hightop COVID-19 IgM/IgG Ab Rapid Test Kit

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

Device identification number
325
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
IgG, IgM
Targets
nucleocapsid protein
Specimen
Plasma, Serum, 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
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
100 U/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
4 %
False negatives
7 %
Precision
Evaluated
Accuracy
92.8 (IgM)
Accuracy
96.5 % (IgG)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
82 % (IgM)
Clinical Sensitivity
93 % (IgG)
Type of antigen
Nucleoprotein
Notes
Rapid diagnostic test cassette

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