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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Neutralizing Antibody Rapid Test

Manufactured by ACON Biotech (Hangzhou) Co., Ltd., China - https://www.aconbio.com/ 

Device identification number
2603
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based, Near POC / POC
Physical Support
Cassette
Target type
Antibody
Specimen
Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-09-03 02:17:51 CET
Comments
NA
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Neutralization Antibody (NAb)
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
1 %
Fp
1.33 % ((Fingertip Blood))
Fn
4.35 %
Fn
2.63 % ((Fingertip Blood))
Precision
Evaluated
Accuracy
97.78 %
Accuracy
98.23 % ((Fingertip Blood))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.65 %
Clinical Sensitivity
97.37 % ((Fingertip Blood))
Clinical Specificity
99 %
Clinical Specificity
98.67 % ((Fingertip Blood))
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