SARS-CoV-2 Neutralizing Antibody Fast Test Kit (Immunofluorescence Assay)
Manufactured by Getein Biotech Inc., China - en.bio-gp.com.cn
Device identification number
2592
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Semi-automated
Physical Support
Card, Lateral flow
Target type
Antibody
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), Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Immunodeficiency Virus (HIV), Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
SARS-CoV-2 Neutralizing Antibody Fast Test Kit (Immunofluorescence Assay) is intended for in vitro qualitative detection of SARS-CoV-2 neutralizing antibody in serum, plasma or whole blood samples. The test is only used for professional and laboratory use, not for home testing.
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
Detection Principle
Immunofluorescence
LOD
0.50 BAU/mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.38 % (1 of 257)
False negatives
0.65 % (1 of 152)
Precision
Evaluated
Accuracy
99.51 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.34 %
Clinical Specificity
99.61 %
Type of antigen
Other
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