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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Neutralizing antibody Test Kit (ELISA)

Manufactured by Biosino Bio-Technology and Science Inc., China - www.sinobio.com.cn/ 

Device identification number
2857
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual, Semi-automated
Physical Support
Microplate
Target type
Antibody
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The SARS-CoV-2 Neutralizing Antibody Test Kit (Enzyme-Linked Immunosorbent Assay,ELISA) is intended for in vitro concentration quantification of total neutralizing antibodies to SARS-CoV-2 in human serum or plasma. The kit is only intended for testing people who have received SARS-CoV-2 vaccine, cannot be used as the basis for the confirmation and exclusion of infectious SARS-CoV-2 pneumonia, and is not applicable for general population screening.
Assay Type
Immuno-Antibody
Self Test
No
Reader Required
Yes
Method
ELISA
Measurement
Quantitative
Time
120 minutes
Subclass
Neutralization Antibody (NAb)
LOD
0.1 µg/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
98.75 % (serum)
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.25 % (serum)
Clinical Specificity
100 % (serum)
Type of antigen
Spike protein

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