SARS-CoV-2 Neutralizing Antibody Detection Kit
Manufactured by FENG CHUN YUAN MEDICAL EQUIPMENT(SHENZHEN) Co. Ltd., China - www.fcy-medical.com
Device identification number
2598
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Influenza A, Influenza B, MERS-CoV, Respiratory Syncytial V (RSV)
Lineages detected
B.1.1.7 (Alpha), B.1.617.1 (Kappa)
Commercial Status
In development
Last Update
2022-08-24 09:08:01 CET
Comments
The SARS-CoV-2 Neutralizing Antibody Test Kit can be used for in-vitro semi-quantitative detection of SARS-CoV-2 neutralizing antibody in human serum, plasma or whole blood samples, which is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The SARS-CoV-2 Neutralizing Antibody Test Kit should not be used to diagnose or exclude acute SARS-CoV-2 infection. For professional use only.
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Semiquantitative
Time
15 minutes
Subclass
Sandwich
LOD
20 IU/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 0 out of 27
False negatives
0 % 0 out of 28
Precision
Evaluated
Accuracy
95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % (28/28,, (95% CI 87.94%~100%))
Clinical Specificity
100 % (27/27, (95% CI 87.54%~100%))
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