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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AMPER COVID-19 Neutralizing Antibody Rapid Testing kit (Colloidal Gold)

Manufactured by AMPER Inc., United States - http://www.amperbio.com 

Device identification number
2873
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antibody
Targets
angiotensin-converting enzyme 2
Specimen
Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
See IFU
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
30 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Colloidal gold
LOD
Not evaluated
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
5 %
False negatives
6 %
Precision
Evaluated
Accuracy
93.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90 %
Clinical Specificity
97 %

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