Corona Virus (COVID-19) Combined (IgM/IgG/Neutralizing antibody) Rapid Test (Colloidal gold)
Manufactured by Hoyotek Biomedical Co. Ltd., China - http://hoyotek.cn/
Device identification number
1930
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This kit consists of test card 1 and test card 2. Test card 1 adopts the principle of colloidal gold immunochromatographic sandwich method to detect the novel Corona Virus (COVID-19) IgM / IgG antibody. When a positive sample is added to the sample well，COVID-19 Antibodies (IgM/IgG) in the sample will be combined with colloidal gold labeled COVID-19 RBD recombinant protein and form into immune complexes。When reaching Test Zone, the complexes will be combined with mouse anti-human IgM monoclonal antibody and mouse anti-human IgG monoclonal antibody. M line and G line occur red color. When testing negative samples, there’s no COVID-19 IgM or IgG in the samples, no immune complexes will be formed and color only appears in the Control line. Test card 2 adopts the principle of colloidal gold immunochromatographic competition method to detect Neutralizing antibody. When testing negative samples, colloidal gold labeled ACE2 protein will be combined with COVID-19 RBD recombinant protein which coated on test line and the detection line develops color. When a positive sample is added to the sample well, COVID-19 Neutralizing antibody in the sample mix with colloidal gold labeled ACE2 protein, and does not bind to COVID-19 RBD recombinant protein. The intensity of T line color is) less than C line.
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
Detection Principle
Colloidal gold
LOD
0.5 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
3 %
False negatives
1 %
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
99 %
Clinical Specificity
97 %
Type of antigen
Other
Notes
Neutralizing antibody
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