COVID-19 Neutralizing Antibody Rapid Test Kit( Whole blood/Serum/Plasma)
Manufactured by Safecare Biotech (Hangzhou) Co. Ltd., China - www.safecare.com.cnre.com.cn
Device identification number
2199
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody
Specimen
Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
LoD:Internal positive control- 5 times diluted
Assay Type
Immuno-Antibody
Subcategory
Validity test kit
Method
Immunochromatography
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
5 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.24 %
False negatives
0.71 %
Precision
Evaluated
Accuracy
99.52 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.29 %
Clinical Specificity
99.76 %
Type of antigen
Nucleoprotein
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