Coretests COVID-19 Neutralizing Ab Test
Manufactured by Core Technology Co. Ltd.
Device identification number
1923
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
COVID-19 Neutralizing Ab Test is used for qualitative detection of the Neutralizing antibodies in patients who have recovered from Novel Coronavirus Pneumonia or those who have been vaccinated. The neutralizing antibody protects the host from infection by neutralizing the activity of the virus. It is a specific antibody that can block the virus from invading cells. The neutralizing antibody is produced by the immune response after a person is vaccinated or infected with a virus. Its titer will directly determine the body's ability to neutralize the virus, that is, the body's ability to avoid virus infection. Coretests® COVID-19 Neutralizing Ab Test can detect neutralizing antibodies faster, and the test only takes 10-15 minutes.
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
AU 25
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
% 0.7%
False negatives
% 0.8%
Precision
Evaluated
Accuracy
% 99.3
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
% 99.2
Clinical Specificity
% 99.3
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