Veri-Q SARS-CoV-2 Neutralizing Antibody Rapid Test Kit
Manufactured by MiCo Biomed Co. Ltd., South Korea - www.micobiomed.com/
Device identification number
2791
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 HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Hemophilus Influenzae, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, MERS-CoV, Respiratory Syncytial V (RSV), SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test is a lateral flow immunoassay intended for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in human plasma from anticoagulated blood, serum, finger-stick whole blood or venous whole blood samples. The Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test 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 Veri-Q SARS-CoV-2 Neutralizing Antibody Detection Rapid Test should not be used to diagnose or exclude acute SARS-CoV-2 infection.
Assay Type
Immuno-Antibody
Method
Immunochromatography
Time
20 minutes
Subclass
Neutralization Antibody (NAb)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Specificity
95.6 %
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