SARS-CoV-2 Neutralizing Antibody Quantitative Test Kit (Immunofluorescence Method)
Manufactured by Wuhan EasyDiagnosis Biomedicine Co. Ltd., China - http://www.easydiagnosis.com.cn/
Device identification number
3996
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody
Antibody type
Monoclonal
Targets
spike protein
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Immunodeficiency Virus (HIV), Human Metapneumovirus (HMPV), Influenza A, Influenza B, Mycobacterium Tuberculosis, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), 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), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Self Test
No
Reader Required
Yes
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Quantitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Immunofluorescence
LOD
20 AU/mL
Analytical Sensitivity
100 %
Analytical Specificity
100 %
False positives
0 %
False negatives
0 %
Accuracy
98.84 %
Clinical Sensitivity
97.12 %
Clinical Specificity
99.39 %
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