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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold)

Manufactured by Beijing Hotgen Biotech Co., Ltd., China - www.hotgen.com.cn 

Device identification number
2808
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody
Specimen
Peripheral blood, Serum, Venous whole blood, Whole blood with anti-coagulants
Pathogens detected
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV
Commercial Status
Commercialised
Last Update
2021-12-10 04:39:02 CET
Comments
There are acolorimetric cards in the product, and the user can judge the semi-quantitative result based on the colorimetric card.
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Semiquantitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
0.25 AU (The cut off Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies in serum samples detected by this kit was determined to be 0.250(O)
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.69 % (869 samples have 6 false positives)
Fn
1.47 % (339 samples have 5 false negatives)
Precision
Evaluated
Accuracy
99.09 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.53 % IgG
Clinical Specificity
99.31 % 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