Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Antibody Test

Manufactured by LumiraDX, United Kingdom - www.lumiradx.com 

Device identification number
1147
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antibody, IgA
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
https://www.lumiradx.com/uk-en/what-we-do/diagnostics/test-technology/antibody-test; https://www.lumiradx.com/assets/pdfs/covid-19-antibody-test/s-com-art-00532_r2_sars_cov-2_ab_test_strip_product_insert_ce.pdf
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
11 minutes
Detection Principle
Immunofluorescence
Crossreactivity
not cross reactivity with samples positive for antibody to Influenza A, Influenza B, Hepatitis C Virus, Hepatitis B Virus (Genotype D) Hemophilus influenzae, human coronaviruses (HKU1, NL63, OC43 and 229E), Anti-Nuclear Antibody, Respiratory Syncytial V
Clinical Sensitivity
97.2 %
Clinical Specificity
100 %

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