Novel Coronavirus(SARS-CoV-2) Neutralizing AntibodiesTest (Up-converting Phosphor Immunochromatographic Technology)
Manufactured by Beijing Hotgen Biotech Co. Ltd., China
Device identification number
2809
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody
Specimen
Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
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), 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
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, C.37 (Lambda)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Products need to pass UPT instrument testing to obtain results.
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Other ()
Method
Immunochromatography
Measurement
Quantitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Phosphor technology
LOD
0.25 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.57 % (869 negative samples have 5 false positives.)
False negatives
1.17 % (339 positive samples have 4 false negatives.)
Precision
Evaluated
Accuracy
99.25 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.82 % IgG
Clinical Specificity
99.42 % 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