COVIDTECH One Step SARS-CoV-2 IgM/IgG Antibody Rapid Test
Manufactured by Qingdao Hightop Biotech Co. Ltd., China - www.hightopbio.com
Device identification number
1452
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, 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
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
200 IU/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
18 % IgM (54/300 )
False positives
7 % IgG (21/300)
False negatives
4 % IgM (40/1000 )
False negatives
25 % IgG (25/100)
Precision
Not evaluated
Accuracy
97 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
92 % IgM
Clinical Sensitivity
96 % IgG
Type of antigen
nucleoprotein
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